Scholars@Duke
Daniel Kelly Benjamin Jr.

Daniel Kelly Benjamin Jr.

Kiser-Arena Distinguished Professor
Pediatrics, Infectious Diseases
Duke Box 17969, Duke Clinical Research Institute, Durham, NC 27710
300 W Morgan St, Suite 800, Durham, NC 27701

Selected Publications

Epidemiology and outcomes of bacterial meningitis in the neonatal intensive care unit.

Journal Article J Perinatol · December 2024 OBJECTIVE: Examine pathogen distribution, antibiotic resistance patterns, and hospital outcomes of infants with bacterial meningitis in neonatal intensive care units (NICUs) in the US from 2013-2018. STUDY DESIGN: Infants were divided into 2 groups based o ... Full text Link to item Cite

Pharmacokinetics of Dexamethasone in Children and Adolescents with Obesity.

Journal Article J Clin Pharmacol · December 2024 Dexamethasone is a synthetic glucocorticoid approved for treating disorders of various organ systems in both adult and pediatric populations. Currently, approved pediatric dosing recommendations are weight-based, but it is unknown whether differences in de ... Full text Link to item Cite

Trends in Gabapentin Use in Neonatal Intensive Care Units from 2005 to 2020.

Journal Article Am J Perinatol · November 25, 2024 OBJECTIVE:  This study aimed to analyze trends in gabapentin use in neonatal intensive care units (NICUs) and examine demographic characteristics, diagnoses, and concomitant medications associated with its use. STUDY DESIGN:  Cohort study of 987,181 infant ... Full text Link to item Cite

Pharmacoepidemiology of combination pulmonary vasodilator therapy in critically ill infants.

Journal Article Cardiol Young · October 16, 2024 BACKGROUND: New drugs to target different pathways in pulmonary hypertension has resulted in increased combination therapy, but details of this use in infants are not well described. In this large multicenter database study, we describe the pharmacoepidemi ... Full text Link to item Cite

Epidemiology and treatment of herpes simplex virus in the neonatal intensive care unit.

Journal Article J Perinatol · October 11, 2024 OBJECTIVE: Describe the epidemiology and clinical characteristics of infants in the neonatal intensive care unit (NICU) with acyclovir exposure and herpes simplex virus (HSV) infection. STUDY DESIGN: Our primary analysis was to evaluate the prevalence of H ... Full text Link to item Cite

Postdiscontinuation Antibiotic Exposure in Hospitalized Infants at Risk for Late-onset Sepsis in the Neonatal Intensive Care Unit.

Journal Article Pediatr Infect Dis J · October 1, 2024 BACKGROUND: In the neonatal intensive care unit, infants are at risk for late-onset sepsis. When blood cultures are negative, antibiotic stewardship efforts encourage stopping antibiotics, yet the duration of therapeutic exposure after the last dose is unk ... Full text Link to item Cite

Physiologically-based pharmacokinetic modeling of pantoprazole to evaluate the role of CYP2C19 genetic variation and obesity in the pediatric population.

Journal Article CPT Pharmacometrics Syst Pharmacol · August 2024 Pantoprazole is a proton pump inhibitor indicated for the treatment of gastroesophageal reflux disease, a condition that disproportionately affects children with obesity. Appropriately dosing pantoprazole in children with obesity requires understanding the ... Full text Link to item Cite

Characterizing Enoxaparin's Population Pharmacokinetics to Guide Dose Individualization in the Pediatric Population.

Journal Article Clin Pharmacokinet · July 2024 BACKGROUND AND OBJECTIVE: Pediatric dosing of enoxaparin was derived based on extrapolation of the adult therapeutic range to children. However, a large fraction of children do not achieve therapeutic anticoagulation with initial dosing. We aim to use real ... Full text Link to item Cite

Acyclovir Dosing Practices Across a Multicenter Cohort of Neonatal Intensive Care Units.

Journal Article Pediatr Infect Dis J · June 26, 2024 BACKGROUND: Acyclovir is the first-line therapy for neonatal herpes simplex virus infections. Therapy can mitigate morbidity and mortality but carries a risk for toxicity. We aimed to compare acyclovir dosing in neonatal intensive care units to published r ... Full text Link to item Cite

Direct-to-participant recruitment of mothers and infants: A strategic approach during challenging pandemic times.

Journal Article Contemp Clin Trials Commun · April 2024 Under traditional circumstances, most clinical trials rely on in-person operations to identify, recruit, and enroll study participants and to complete study-related visits. During unusual circumstances, such as the COVID-19 pandemic, the typical clinical t ... Full text Link to item Cite

Abatacept Pharmacokinetics and Exposure Response in Patients Hospitalized With COVID-19: A Secondary Analysis of the ACTIV-1 IM Randomized Clinical Trial.

Journal Article JAMA Netw Open · April 1, 2024 IMPORTANCE: The pharmacokinetics of abatacept and the association between abatacept exposure and outcomes in patients with severe COVID-19 are unknown. OBJECTIVE: To characterize abatacept pharmacokinetics, relate drug exposure with clinical outcomes, and ... Full text Link to item Cite

Morbidity and mortality of twins and triplets compared to singleton infants delivered between 26-34 weeks gestation in the United States.

Journal Article J Perinatol · February 2024 OBJECTIVE: To describe in-hospital morbidities and mortality among twins and triplets delivered at ≥26 to ≤34 weeks gestational age (GA) while controlling for prematurity and growth restriction. STUDY DESIGN: Retrospective analysis of inborn infants discha ... Full text Link to item Cite

Trends in COVID-19 diagnoses and outcomes in infants hospitalized in the neonatal intensive care unit.

Journal Article J Perinatol · January 2024 OBJECTIVE: Characterize the prevalence of coronavirus disease 2019 (COVID-19) diagnosis among mothers with infants hospitalized in 294 neonatal intensive care units (NICUs), and demographics and outcomes of infants with severe acute respiratory syndrome co ... Full text Link to item Cite

Risk factors and epidemiology of spontaneous intestinal perforation among infants born at 22-24 weeks' gestational age.

Journal Article J Perinatol · January 2024 OBJECTIVE: To describe the epidemiology, risk factors, and timing of spontaneous intestinal perforation (SIP) among infants born at 22-24 weeks' gestational age (GA). STUDY DESIGN: Observational cohort study among infants born at 22-24 weeks' GA in 446 neo ... Full text Link to item Cite

Clinical Pharmacology of Antiinfective Drugs

Chapter · January 1, 2024 Neonates and young infants are at risk for serious bacterial, viral, and fungal infections. Dosing of antiinfective drugs in young infants is challenging. Effective antimicrobial treatment typically begins with empiric therapy at a dose that is most likely ... Full text Cite

Neonatal Infections

Chapter · January 1, 2024 Full text Cite

Association Between Hypoglycemia and the Occurrence of Early Onset Sepsis in Premature Infants.

Journal Article J Pediatric Infect Dis Soc · December 26, 2023 BACKGROUND: We examined the association between hypoglycemia and the occurrence of early onset sepsis (EOS) in premature infants admitted to the neonatal intensive care unit (NICU). METHODS: We included infants discharged from 358 NICUs between 1997 and 20 ... Full text Link to item Cite

Trends in Pediatric Emergency and Inpatient Healthcare Use for Mental and Behavioral Health Among North Carolinians During the Early COVID-19 Pandemic.

Journal Article J Pediatric Infect Dis Soc · December 26, 2023 BACKGROUND: Widespread school closures and health care avoidance during the COVID-19 pandemic led to disruptions in access to pediatric mental health care. METHODS: We conducted a retrospective study of emergency and inpatient administrative claims from pr ... Full text Link to item Cite

Diagnostic Utility of Cerebrospinal Fluid White Blood Cell Components for the Identification of Bacterial Meningitis in Infants.

Journal Article J Pediatric Infect Dis Soc · December 26, 2023 BACKGROUND: To evaluate the diagnostic and predictive utility of cerebrospinal fluid (CSF) white blood cell (WBC) components in the diagnosis of bacterial meningitis in infants discharged from the neonatal intensive care unit (NICU). METHODS: We identified ... Full text Link to item Cite

Leveraging School Infection Data to Address Community COVID-19 Data Gaps.

Journal Article J Pediatric Infect Dis Soc · December 26, 2023 BACKGROUND: At-home COVID-19 tests became available in the USA in April 2021 with widespread use by January 2022; however, the lack of infrastructure to report test results to public health agencies created a gap in public health data. Kindergarten through ... Full text Link to item Cite

Late-Onset Sepsis Evaluation and Empiric Therapy in Extremely Low Gestational Age Newborns.

Journal Article J Pediatric Infect Dis Soc · December 26, 2023 BACKGROUND: Little is known about late-onset sepsis (LOS) evaluations in extremely low gestational age newborns (ELGANs). We describe frequencies of LOS evaluation in ELGANs, infant characteristics, and empiric therapy choices during evaluations. METHODS: ... Full text Link to item Cite

Impact of the COVID-19 Pandemic on Pediatric Preventive Health Care Among North Carolina Children Enrolled in Medicaid.

Journal Article J Pediatric Infect Dis Soc · December 26, 2023 BACKGROUND: Children enrolled in private insurance had reduced preventive health care during the coronavirus disease 2019 (COVID-19) pandemic. However, the impact of the pandemic on children enrolled in Medicaid has been minimally described. METHODS: We us ... Full text Link to item Cite

Duke STAR Program.

Journal Article J Pediatric Infect Dis Soc · December 26, 2023 Full text Link to item Cite

School Absenteeism as a Marker for Community COVID-19 Rates.

Journal Article J Pediatric Infect Dis Soc · December 26, 2023 BACKGROUND: Reported community transmission rates of coronavirus disease 2019 (COVID-19) may not be accurate, particularly since at-home testing has become widely available. School absenteeism may serve as a marker of broader community COVID-19 transmissio ... Full text Link to item Cite

Leveraging the Expertise of the CTSA Program to Increase the Impact and Efficiency of Clinical Trials.

Journal Article JAMA Netw Open · October 2, 2023 IMPORTANCE: Multicenter clinical trials play a critical role in the translational processes that enable new treatments to reach all people and improve public health. However, conducting multicenter randomized clinical trials (mRCT) presents challenges. The ... Full text Link to item Cite

Use of vasopressors for septic shock in the neonatal intensive care unit.

Journal Article J Perinatol · October 2023 OBJECTIVE: To describe outcomes for infants in the neonatal intensive care unit with septic shock based on the vasopressor administered. METHODS: This is a multicenter cohort study of infants with an episode of septic shock. We evaluated the primary outcom ... Full text Link to item Cite

Identifying Foods That Optimize Intake of Key Micronutrients During Pregnancy.

Journal Article J Nutr · October 2023 BACKGROUND: Most pregnant women in the United States are at risk of inadequate intake of vitamin A, vitamin D, folic acid, calcium, iron, and omega-3 fatty acids from foods alone. Very few United States dietary supplements provide sufficient doses of all 6 ... Full text Link to item Cite

Early antibiotic exposure in very-low birth weight infants and infection risk at 3-7 days after birth.

Journal Article J Perinatol · September 2023 OBJECTIVE: To determine rates of late-onset infection (LOI) during postnatal days 3-7 among preterm infants, based on antibiotic exposure during days 0-2. STUDY DESIGN: Retrospective cohort study of infants born <1500 grams and ≤30 weeks gestation, 2005-20 ... Full text Link to item Cite

Caregiver Perceived Stress and Child Sleep Health: An Item-Level Individual Participant Data Meta-Analysis

Journal Article Journal of Child and Family Studies · August 1, 2023 Up to 50% of children and adolescents in the United States (U.S.) experience sleep problems. While existing research suggests that perceived stress in caregivers is associated with poorer sleep outcomes in children, research on this relationship is often l ... Full text Cite

Abatacept, Cenicriviroc, or Infliximab for Treatment of Adults Hospitalized With COVID-19 Pneumonia: A Randomized Clinical Trial.

Journal Article JAMA · July 25, 2023 IMPORTANCE: Immune dysregulation contributes to poorer outcomes in COVID-19. OBJECTIVE: To investigate whether abatacept, cenicriviroc, or infliximab provides benefit when added to standard care for COVID-19 pneumonia. DESIGN, SETTING, AND PARTICIPANTS: Ra ... Full text Open Access Link to item Cite

Building School-Academic Partnerships to Implement COVID-19 Testing in Underserved Populations.

Journal Article Pediatrics · July 1, 2023 OBJECTIVE: In April 2021, the US government made substantial investments in students' safe return to school by providing resources for school-based coronavirus disease 2019 (COVID-19) mitigation strategies, including COVID-19 diagnostic testing. However, t ... Full text Link to item Cite

In-Person Instruction and Educational Outcomes of K-8 Students During the COVID-19 Pandemic.

Journal Article Pediatrics · July 1, 2023 OBJECTIVES: Quantify the relationship between district policy permitting in-person instruction and educational outcomes during the 2020 to 2021 academic year for kindergarten through eighth grade students. METHODS: An ecological, repeated cross-sectional a ... Full text Link to item Cite

Common Data Element Collection in Underserved School Communities: Challenges and Recommendations.

Journal Article Pediatrics · July 1, 2023 OBJECTIVES: To provide recommendations for future common data element (CDE) development and collection that increases community partnership, harmonizes data interpretation, and continues to reduce barriers of mistrust between researchers and underserved co ... Full text Link to item Cite

Utilization and Impact of Symptomatic and Exposure SARS-CoV-2 Testing in K-12 Schools.

Journal Article Pediatrics · July 1, 2023 OBJECTIVES: The Centers for Disease Control and Prevention recommend that schools can offer severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostic (on-demand) testing for students and staff with coronavirus disease 2019 symptoms or exposur ... Full text Link to item Cite

Dexmedetomidine Opioid Sparing Effect in Mechanically Ventilated Children (DOSE): Trial of Fentanyl versus Fentanyl + Dexmedetomidine for Maintenance of Sedation

Journal Article Journal of Pediatric Intensive Care · May 26, 2023 Abstract Objectives This article observes the mean daily dose of fentanyl required for adequate sedation in critically ill, mechanically ventilated children randomized to receive dexmedetomidine or placebo. Full text Cite

Test-to-Stay in Kindergarten Through 12th Grade Schools After Household Exposure to Severe Acute Respiratory Syndrome Coronavirus 2.

Journal Article J Sch Health · May 2023 BACKGROUND: Test-to-stay (TTS) is a strategy to limit school exclusion following an exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We evaluated the use of TTS within universally masked kindergarten through 12th grade (K-12) schoo ... Full text Open Access Link to item Cite

Assessing clinical site readiness for electronic health record (EHR)-to-electronic data capture (EDC) automated data collection.

Journal Article Contemporary clinical trials · May 2023 BackgroundeSource software is used to automatically copy a patient's electronic health record data into a clinical study's electronic case report form. However, there is little evidence to assist sponsors in identifying the best sites for multi-ce ... Full text Cite

Defining Variability in Evaluation and Management of Children with Chronic Osteomyelitis.

Journal Article J Pediatric Infect Dis Soc · April 28, 2023 Pediatric chronic osteomyelitis is a rare, debilitating condition lacking management guidelines. In a national survey of 162 pediatric infectious disease physicians through the Emerging Infections Network, tremendous variability in diagnostic approaches an ... Full text Link to item Cite

Caregivers of Black and Latino/a/x Students and School Personnel Perspectives on School-Based SARS-CoV-2 Testing: Implications for Testing and Test-to-Stay Programs in K-12 Schools.

Journal Article J Sch Health · March 2023 BACKGROUND: "Test-to-stay" (TTS) is an effective approach for keeping students in school post-exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). To prepare for school-based SARS-CoV-2 testing, we implemented formative research to gat ... Full text Link to item Cite

Birth Outcomes in Relation to Prenatal Exposure to Per- and Polyfluoroalkyl Substances and Stress in the Environmental Influences on Child Health Outcomes (ECHO) Program.

Journal Article Environ Health Perspect · March 2023 BACKGROUND: Per- and polyfluoroalkyl substances (PFAS) are persistent and ubiquitous chemicals associated with risk of adverse birth outcomes. Results of previous studies have been inconsistent. Associations between PFAS and birth outcomes may be affected ... Full text Link to item Cite

SARS-CoV-2 Screening Testing Programs for Safe In-person Learning in K-12 Schools.

Journal Article J Pediatric Infect Dis Soc · February 27, 2023 BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) screening testing is a recommended mitigation strategy for schools, although few descriptions of program implementation are available. METHODS: Kindergarten through 12th grade (K-12) ... Full text Link to item Cite

Mechanisms to expedite pediatric clinical trial site activation: The DOSE trial experience.

Journal Article Contemp Clin Trials · February 2023 BACKGROUND: Timely trial start-up is a key determinant of trial success; however, delays during start-up are common and costly. Moreover, data on start-up metrics in pediatric clinical trials are sparse. To expedite trial start-up, the Trial Innovation Net ... Full text Link to item Cite

Exposure-response Relationships of Metronidazole in Infants: Integration of Electronic Health Record Data With Population Pharmacokinetic Modeling-derived Exposure Simulation.

Journal Article Pediatr Infect Dis J · January 1, 2023 BACKGROUND: Infants frequently receive metronidazole at variable doses and duration for surgical site infection prophylaxis and treatment of intra-abdominal infections. Seizures are a rare (but potentially devastating) side effect of metronidazole, yet the ... Full text Link to item Cite

Approaches for enhancing the informativeness and quality of clinical trials: Innovations and principles for implementing multicenter trials from the Trial Innovation Network.

Journal Article J Clin Transl Sci · 2023 One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but i ... Full text Open Access Link to item Cite

Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned.

Journal Article J Clin Transl Sci · 2023 New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitati ... Full text Link to item Cite

Development, implementation, and dissemination of operational innovations across the trial innovation network.

Journal Article J Clin Transl Sci · 2023 Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are unsuccessfu ... Full text Link to item Cite

Comparative Effectiveness of Dual- Versus Mono-Sedative Therapy on Opioid Administration, Sedative Administration, and Sedation Level in Mechanically Ventilated, Critically Ill Children.

Journal Article J Pediatr Pharmacol Ther · 2023 OBJECTIVE: We estimated the effect of early initiation of dual therapy vs monotherapy on drug administration and related outcomes in mechanically ventilated, critically ill children. METHODS: We used the electronic medical record at a single tertiary medic ... Full text Link to item Cite

Use of Electronic Health Records to Identify Exposure-Response Relationships in Critically Ill Children: An Example of Midazolam and Delirium.

Journal Article J Pediatr Intensive Care · December 2022 Adverse drug events are common in critically ill children and often result from systemic or target organ drug exposure. Methods of drug dosing and titration that consider pharmacokinetic alterations may improve our ability to optimally dose critically ill ... Full text Link to item Cite

Safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia: Rationale and methods of a phase II randomized trial.

Journal Article Contemp Clin Trials Commun · December 2022 Bronchopulmonary dysplasia (BPD) is a disease of chronic respiratory insufficiency stemming from premature birth and iatrogenic lung injury leading to alveolar simplification, impaired alveolar-capillary development, interstitial fibrosis, and often pulmon ... Full text Link to item Cite

Test-to-Stay After SARS-CoV-2 Exposure: A Mitigation Strategy for Optionally Masked K-12 Schools.

Journal Article Pediatrics · November 1, 2022 OBJECTIVES: We evaluated the impact of a test-to-stay (TTS) program on within-school transmission and missed school days in optionally masked kindergarten through 12th grade schools during a period of high community severe acute respiratory syndrome corona ... Full text Open Access Link to item Cite

Abatacept for Treatment of Adults Hospitalized with Moderate or Severe Covid-19.

Journal Article medRxiv · September 26, 2022 BACKGROUND: We investigated whether abatacept, a selective costimulation modulator, provides additional benefit when added to standard-of-care for patients hospitalized with Covid-19. METHODS: We conducted a master protocol to investigate immunomodulators ... Full text Link to item Cite

Infliximab for Treatment of Adults Hospitalized with Moderate or Severe Covid-19.

Journal Article medRxiv · September 26, 2022 BACKGROUND: Immune dysregulation contributes to poorer outcomes in severe Covid-19. Immunomodulators targeting various pathways have improved outcomes. We investigated whether infliximab provides benefit over standard of care. METHODS: We conducted a maste ... Full text Link to item Cite

Use of Real-World Data and Physiologically-Based Pharmacokinetic Modeling to Characterize Enoxaparin Disposition in Children With Obesity.

Journal Article Clin Pharmacol Ther · August 2022 Dosing guidance for children with obesity is often unknown despite the fact that nearly 20% of US children are classified as obese. Enoxaparin, a commonly prescribed low-molecular-weight heparin, is dosed based on body weight irrespective of obesity status ... Full text Link to item Cite

Ampicillin dosing in premature infants for early-onset sepsis: exposure-driven efficacy, safety, and stewardship.

Journal Article J Perinatol · July 2022 OBJECTIVE: Define optimal ampicillin dosing for empiric early-onset sepsis (EOS) therapy in preterm neonates. STUDY DESIGN: We simulated ampicillin concentrations in newborns (birthweight < 1500 g; gestational age 22-27 weeks), summarizing three 48 h regim ... Full text Link to item Cite

Solithromycin in Children and Adolescents With Community-acquired Bacterial Pneumonia.

Journal Article Pediatr Infect Dis J · July 1, 2022 BACKGROUND: Solithromycin is a new macrolide-ketolide antibiotic with potential effectiveness in pediatric community-acquired bacterial pneumonia (CABP). Our objective was to evaluate its safety and effectiveness in children with CABP. METHODS: This phase ... Full text Open Access Link to item Cite

Exposure-safety relationship for acyclovir in the treatment of neonatal herpes simplex virus disease.

Journal Article Early Hum Dev · July 2022 BACKGROUND: Neonatal herpes simplex virus (HSV) disease has been treated with high-dose (20 mg/kg/dose) acyclovir since 1991. AIMS: Determine the safety of acyclovir in infants with neonatal HSV treated with high-dose acyclovir; examine the association bet ... Full text Open Access Link to item Cite

Developing lay summaries and thank you notes in paediatric pragmatic clinical trials.

Journal Article Health Expect · June 2022 INTRODUCTION: Better transparency of research results and participant engagement may help address poor participant accrual in paediatric clinical research. We conducted formative research to assess the acceptability of lay summaries and thank you notes, as ... Full text Link to item Cite

School Masking Policies and Secondary SARS-CoV-2 Transmission.

Journal Article Pediatrics · June 1, 2022 OBJECTIVES: Throughout the COVID-19 pandemic, masking has been a widely used mitigation practice in kindergarten through 12th grade (K-12) school districts to limit within-school transmission. Prior studies attempting to quantify the impact of masking have ... Full text Link to item Cite

Use of physiologically-based pharmacokinetic modeling to inform dosing of the opioid analgesics fentanyl and methadone in children with obesity.

Journal Article CPT Pharmacometrics Syst Pharmacol · June 2022 Obesity is an increasingly alarming public health threat, with nearly 20% of children classified as obese in the United States today. Children with obesity are commonly prescribed the opioids fentanyl and methadone, and accurate dosing is critical to reduc ... Full text Link to item Cite

A Qualitative Analysis of the Remote Food Photography Method and the Automated Self-Administered 24-hour Dietary Assessment Tool for Assessing Children's Food Intake Reported by Parent Proxy.

Journal Article J Acad Nutr Diet · May 2022 BACKGROUND: Accuracy and participant burden are two key considerations in the selection of a dietary assessment tool for assessing children's full-day dietary intake. OBJECTIVE: The aim of this study was to identify barriers experienced by parents and burd ... Full text Link to item Cite

SARS-CoV-2 Infections and Incidence at a North Carolina Pre-Kindergarten-12 School During In-Person Education: August 2020 to January 2021.

Journal Article J Sch Health · May 2022 BACKGROUND: School closures were initially believed to mitigate SARS-CoV-2, but instead may have had a limited role in reducing community SARS-CoV-2 transmission. We describe a single school's experience with in-person education during the COVID-19 pandemi ... Full text Link to item Cite

Test-to-Stay After Exposure to SARS-CoV-2 in K-12 Schools.

Journal Article Pediatrics · May 1, 2022 OBJECTIVES: We evaluated the safety and efficacy of a test-to-stay program for unvaccinated students and staff who experienced an unmasked, in-school exposure to someone with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. ... Full text Open Access Link to item Cite

Development and Evaluation of a Virtual Population of Children with Obesity for Physiologically Based Pharmacokinetic Modeling.

Journal Article Clin Pharmacokinet · February 2022 BACKGROUND AND OBJECTIVE: While one in five children in the USA are now obese, and more than three-quarters receive at least one drug during childhood, there is limited dosing guidance for this vulnerable patient population. Physiologically based pharmacok ... Full text Link to item Cite

Secondary Transmission of COVID-19 in K-12 Schools: Findings From 2 States.

Journal Article Pediatrics · February 2022 ObjectivesWe evaluated the impact of distancing practices on secondary transmission of severe acute respiratory syndrome coronavirus 2 and the degree of sports-associated secondary transmission across a large diverse cohort of schools during sprin ... Full text Cite

Masking Adherence in K-12 Schools and SARS-CoV-2 Secondary Transmission.

Journal Article Pediatrics · February 1, 2022 OBJECTIVES: Masking is an essential coronavirus 2019 mitigation tool assisting in the safe return of kindergarten through 12th grade children and staff to in-person instruction; however, masking adherence, compliance evaluation methods, and potential conse ... Full text Link to item Cite

Building a National Framework to Pair Scientists and Schools During a Global Pandemic.

Journal Article Pediatrics · February 1, 2022 The coronavirus disease 2019 (COVID-19) pandemic forced the suspension of in-person education in schools serving students in kindergarten through 12th grade (K-12) across the United States. As time passed, teachers, students, and parents struggled with rem ... Full text Link to item Cite

Quarantine Elimination for K-12 Students With Mask-on-Mask Exposure to SARS-CoV-2.

Journal Article Pediatrics · February 2022 ObjectivesWith layered mitigation strategies, there are low rates of secondary transmission of severe acute respiratory syndrome coronavirus 2; therefore, quarantine after close-contact exposure to severe acute respiratory syndrome coronavirus 2 i ... Full text Cite

Urban Classification, Not COVID-19 Community Rates, Was Associated With Modes of Learning in US K-12 Schools?

Journal Article Pediatrics · February 1, 2022 OBJECTIVES: To identify factors associated with the decision to provide in-person, hybrid, and remote learning in kindergarten through 12th grade school districts during the 2020-2021 school year. METHODS: We performed a retrospective study evaluating scho ... Full text Link to item Cite

From Research to Policy: Reopening K-12 Schools in North Carolina During the COVID-19 Pandemic.

Journal Article Pediatrics · February 1, 2022 School-aged children experienced substantial challenges to health and well-being as a result of school-building closures due to the coronavirus disease 2019 pandemic. In hopes of supporting equitable and safe school reopening for every student across North ... Full text Link to item Cite

A School-Based SARS-CoV-2 Testing Program: Testing Uptake and Quarantine Length After In-School Exposures.

Journal Article Pediatrics · February 1, 2022 OBJECTIVES: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-related quarantines, which are required after close contact with infected individuals, have substantially disrupted in-person education for kindergarten through 12th grade (K-12) stud ... Full text Open Access Link to item Cite

Medication Use in the Neonatal Intensive Care Unit and Changes from 2010 to 2018.

Journal Article J Pediatr · January 2022 OBJECTIVE: To provide up-to-date medication prescribing patterns in US neonatal intensive care units (NICUs) and to examine trends in prescribing patterns over time. STUDY DESIGN: We performed a cohort study of 799 016 infants treated in NICUs managed by t ... Full text Link to item Cite

The Role of Childhood Asthma in Obesity Development: A Nationwide US Multicohort Study.

Journal Article Epidemiology · January 1, 2022 RATIONALE: Asthma and obesity often co-occur. It has been hypothesized that asthma may contribute to childhood obesity onset. OBJECTIVES: To determine if childhood asthma is associated with incident obesity and examine the role of asthma medication in this ... Full text Link to item Cite

Securely sharing DSMB reports to speed decision making from multiple, concurrent, independent studies of similar treatments in COVID-19.

Journal Article J Clin Transl Sci · 2022 INTRODUCTION: As clinical trials were rapidly initiated in response to the COVID-19 pandemic, Data and Safety Monitoring Boards (DSMBs) faced unique challenges overseeing trials of therapies never tested in a disease not yet characterized. Traditionally, i ... Full text Link to item Cite

Sharing data among clinical trials of therapeutics in COVID-19: Barriers and facilitators to collaborating in a crisis.

Journal Article J Clin Transl Sci · 2022 BACKGROUND: The Clinical and Translational Science Award Program (CTSA) Trial Innovation Network (TIN) was launched in 2016 to increase the efficiency and effectiveness of multisite trials by supporting the development of national infrastructure. With the ... Full text Link to item Cite

School Safety, Masking, and the Delta Variant.

Journal Article Pediatrics · December 7, 2021 Full text Link to item Cite

Physiologically Based Pharmacokinetic Modeling of Meropenem in Preterm and Term Infants.

Conference Clin Pharmacokinet · December 2021 BACKGROUND: Meropenem is a broad-spectrum carbapenem antibiotic approved by the US Food and Drug Administration for use in pediatric patients, including treating complicated intra-abdominal infections in infants < 3 months of age. The impact of maturation ... Full text Link to item Cite

Regional and sociodemographic differences in average BMI among US children in the ECHO program.

Journal Article Obesity (Silver Spring) · December 2021 OBJECTIVE: The aim of this study was to describe the association of individual-level characteristics (sex, race/ethnicity, birth weight, maternal education) with child BMI within each US Census region and variation in child BMI by region. METHODS: This stu ... Full text Link to item Cite

School Safety, Masking, and the Delta Variant.

Journal Article Pediatrics · October 8, 2021 Full text Link to item Cite

Community SARS-CoV-2 Surge and Within-School Transmission.

Journal Article Pediatrics · October 2021 OBJECTIVES: When the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic began, experts raised concerns about in-person instruction in the setting of high levels of community transmission. We describe secondary transmission of SARS-CoV-2 ... Full text Link to item Cite

Pharmacokinetics of Ceftazidime in Children and Adolescents with Obesity.

Journal Article Paediatr Drugs · September 2021 PURPOSE: The aim of this study was to evaluate ceftazidime pharmacokinetics (PK) in a cohort that includes a predominate number of children and adolescents with obesity and assess the efficacy of competing dosing strategies. METHODS: A population PK model ... Full text Link to item Cite

Association between neonatal intensive care unit medication safety practices, adverse events, and death.

Journal Article J Perinatol · July 2021 OBJECTIVE: Determine the associations between neonatal intensive care unit (NICU) medication safety practices, laboratory-based adverse events (lab-AEs), and death. STUDY DESIGN: We combined data from a 2016 survey of Pediatrix NICUs on use of medication s ... Full text Link to item Cite

Distributional Properties and Criterion Validity of a Shortened Version of the Social Responsiveness Scale: Results from the ECHO Program and Implications for Social Communication Research.

Journal Article Journal of autism and developmental disorders · July 2021 Prior work proposed a shortened version of the Social Responsiveness Scale (SRS), a commonly used quantitative measure of social communication traits. We used data from 3031 participants (including 190 ASD cases) from the Environmental Influences on Child ... Full text Cite

Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections.

Journal Article Pediatr Infect Dis J · June 1, 2021 BACKGROUND: In premature infants, complicated intraabdominal infections (cIAIs) are a leading cause of morbidity and mortality. Although universally prescribed, the safety and effectiveness of commonly used antibiotic regimens have not been established in ... Full text Link to item Cite

Pediatric Trials Network: Stakeholder views on thanking families and providing study findings on pragmatic pediatric clinical research.

Journal Article Contemp Clin Trials Commun · June 2021 We conducted formative research using in-depth interviews to identify preferences for and anticipated responses to receiving thank you notes and lay summaries of aggregate results among caregivers and adolescent participants of pragmatic pediatric studies ... Full text Link to item Cite

Prolonged Post-Discontinuation Antibiotic Exposure in Very Low Birth Weight Neonates at Risk for Early-Onset Sepsis.

Journal Article J Pediatric Infect Dis Soc · May 28, 2021 BACKGROUND: Premature, very low birth weight (VLBW) neonates are at risk for early-onset sepsis and receive ampicillin and gentamicin post-birth. Antimicrobial stewardship supports short-course antibiotics, but how long antibiotic concentrations remain the ... Full text Link to item Cite

Racial and Ethnic Diversity in Studies Funded Under the Best Pharmaceuticals for Children Act.

Journal Article Pediatrics · May 2021 BACKGROUND AND OBJECTIVES: The Best Pharmaceuticals for Children Act (BPCA) incentivizes the study of on-patent medicines in children and mandates that the National Institutes of Health sponsor research on off-patent drugs important to pediatric therapeuti ... Full text Link to item Cite

Response of the trial innovation network to the COVID-19 pandemic.

Journal Article J Clin Transl Sci · April 20, 2021 INTRODUCTION: The COVID-19 pandemic prompted the development and implementation of hundreds of clinical trials across the USA. The Trial Innovation Network (TIN), funded by the National Center for Advancing Translational Sciences, was an established clinic ... Full text Link to item Cite

Incidence and Secondary Transmission of SARS-CoV-2 Infections in Schools.

Journal Article Pediatrics · April 2021 BackgroundIn an effort to mitigate the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), North Carolina closed prekindergarten through grade 12 public schools to in-person instruction on March 14, 2020. On July 15, 2020, Nort ... Full text Cite

The use of supplemental hydrocortisone in the management of persistent pulmonary hypertension of the newborn.

Journal Article J Perinatol · April 2021 OBJECTIVE: Characterize association between hydrocortisone receipt and hospital outcomes of infants with persistent pulmonary hypertension of the newborn (PPHN). STUDY DESIGN: Cohort study of infants ≥34 weeks with PPHN who received inhaled nitric oxide at ... Full text Link to item Cite

Wide range of perioperative drugs and doses used in inguinal hernia repairs for premature infants.

Journal Article J Perinatol · March 2021 OBJECTIVE: Characterize the types and doses of commonly administered perioperative drugs in inguinal hernia (IH) repair for premature infants. STUDY DESIGN: Single-center, retrospective cohort study. RESULTS: In total, 112 premature infants underwent IH re ... Full text Link to item Cite

Harmonising regulatory approval for antibiotics in children.

Journal Article Lancet Child Adolesc Health · February 2021 Full text Link to item Cite

Physiologically-Based Pharmacokinetic Modeling Characterizes the CYP3A-Mediated Drug-Drug Interaction Between Fluconazole and Sildenafil in Infants.

Journal Article Clin Pharmacol Ther · January 2021 Physiologically-based pharmacokinetic (PBPK) modeling can potentially predict pediatric drug-drug interactions (DDIs) when clinical DDI data are limited. In infants for whom treatment of pulmonary hypertension and prevention or treatment of invasive candid ... Full text Link to item Cite

Early-onset sepsis in term infants admitted to neonatal intensive care units (2011-2016).

Journal Article J Perinatol · January 2021 OBJECTIVES: Investigate characteristics of term infants culture-evaluated for early-onset sepsis (EOS) in neonatal intensive care units (NICUs), frequencies of organisms causing EOS, and factors associated with EOS. STUDY DESIGN: Using a cohort design, we ... Full text Link to item Cite

Impact of COVID-19-related School Closures on the Drivers of Child Health.

Journal Article N C Med J · 2021 The COVID-19 pandemic resulted in large-scale school closures in an effort to reduce the spread of disease. This article reviews the potential impact of COVID-19-related school closures on the health of children in North Carolina, with particular attention ... Full text Link to item Cite

Population Pharmacokinetics of Metoclopramide in Infants, Children, and Adolescents.

Journal Article Clin Transl Sci · November 2020 Metoclopramide is commonly used for gastroesophageal reflux. The aims of the present study were to develop a pediatric population pharmacokinetic (PopPK) model, which was applied to simulate the metoclopramide exposure following dosing used in clinical pra ... Full text Link to item Cite

Simulated Assessment of Pharmacokinetically Guided Dosing for Investigational Treatments of Pediatric Patients With Coronavirus Disease 2019.

Journal Article JAMA Pediatr · October 1, 2020 IMPORTANCE: Children of all ages appear susceptible to severe acute respiratory syndrome coronavirus 2 infection. To support pediatric clinical studies for investigational treatments of coronavirus disease 2019 (COVID-19), pediatric-specific dosing is requ ... Full text Link to item Cite

Safety of Metronidazole in Late Pre-term and Term Infants with Complicated Intra-abdominal Infections.

Journal Article Pediatr Infect Dis J · September 2020 BACKGROUND: Metronidazole is frequently used off-label in infants with complicated intra-abdominal infections (cIAI) to provide coverage against anaerobic organisms, but its safety and efficacy in this indication are unknown. METHODS: In the Antibiotic Saf ... Full text Link to item Cite

Outcomes associated with surfactant in more mature and larger premature infants with respiratory distress syndrome.

Journal Article J Perinatol · August 2020 OBJECTIVE: Examine the effect of off-label surfactant on mortality and morbidity in more mature and larger premature infants diagnosed with respiratory distress syndrome (RDS). STUDY DESIGN: Cohort study of premature infants born at 30-36 weeks, birth weig ... Full text Link to item Cite

Population Analysis of Anidulafungin in Infants to Older Adults With Confirmed or Suspected Invasive Candidiasis.

Journal Article Clin Pharmacol Ther · August 2020 In a pooled population analysis, we investigated the pharmacokinetics of i.v. anidulafungin in four studies across a full range of adult and pediatric ages in patients with confirmed, suspected, or at high risk of invasive candidiasis (IC). Relationships b ... Full text Link to item Cite

Hospital-acquired Pneumonia and Ventilator-associated Pneumonia in Children: A Prospective Natural History and Case-Control Study.

Journal Article Pediatr Infect Dis J · August 2020 BACKGROUND: Clinical trials for antibiotics designed to treat hospital-acquired and ventilator-associated bacterial pneumonias (HABP/VABP) are hampered by making these diagnoses in a way that is acceptable to the United States Food and Drug Administration ... Full text Link to item Cite

Paradoxical Antibiotic Effect of Ampicillin: Use of a Population Pharmacokinetic Model to Evaluate a Clinical Correlate of the Eagle Effect in Infants With Bacteremia.

Journal Article Pediatr Infect Dis J · August 2020 BACKGROUND: High doses of ampicillin are often used to achieve therapeutic drug concentrations in infants. A paradoxical antibiotic effect, often called the Eagle effect, occurs when increasing concentrations of antibiotic above a threshold results in decr ... Full text Link to item Cite

Dosing of Antimicrobials in the Neonatal Intensive Care Unit: Does Clinical Practice Reflect Pharmacokinetics-based Recommendations?

Journal Article Pediatr Infect Dis J · August 2020 BACKGROUND: We sought to compare meropenem and fluconazole dosing in the neonatal intensive care unit with recommendations based on published pharmacokinetic (PK) studies in infants. METHODS: We performed an observational cohort study of infants <90 days p ... Full text Link to item Cite

Probiotic Use and Safety in the Neonatal Intensive Care Unit: A Matched Cohort Study.

Journal Article J Pediatr · July 2020 OBJECTIVE: To determine the prevalence of probiotic administration in infants born preterm over time, as well as the association between probiotic administration and select adverse outcomes. STUDY DESIGN: We performed a multicenter cohort study of infants ... Full text Link to item Cite

Impact of Personal Protective Equipment on Pediatric Cardiopulmonary Resuscitation Performance: A Controlled Trial.

Journal Article Pediatr Emerg Care · June 2020 OBJECTIVES: This study aimed to determine whether personal protective equipment (PPE) results in deterioration in chest compression (CC) quality and greater fatigue for administering health care providers (HCPs). METHODS: In this multicenter study, HCPs co ... Full text Link to item Cite

Medications and in-hospital outcomes in infants born at 22-24 weeks of gestation.

Journal Article J Perinatol · May 2020 OBJECTIVE: To evaluate the most commonly used medications and in-hospital morbidities and mortality in infants born 22-24 weeks of gestation. STUDY DESIGN: Multicenter retrospective cohort study of infants born 22-24 weeks of gestation (2006-2016), without ... Full text Link to item Cite

Impact of Gastrostomy Tube Placement on Short-Term Weight Gain in Hospitalized Premature Infants.

Journal Article JPEN J Parenter Enteral Nutr · February 2020 BACKGROUND: Gastrostomy tube (G-tube) placement is a long-term alternative to oral or nasogastric feeding for premature infants who cannot safely feed orally or need supplemental nutrition for adequate growth. METHODS: We compared daily weight changes for ... Full text Link to item Cite

Development of a Prospective Real-World Data Clinical Registry of Children and Adolescents With Migraine.

Journal Article Headache · February 2020 OBJECTIVE: To develop a multicenter, multistakeholder, prospective clinical registry of children and adolescents with migraine to support the collection of real-world data of sufficient quality to support regulatory submissions and provide site-based infra ... Full text Link to item Cite

A review of maternal prenatal exposures to environmental chemicals and psychosocial stressors-implications for research on perinatal outcomes in the ECHO program.

Journal Article J Perinatol · January 2020 Exposures to environmental chemicals and psychosocial stressors during pregnancy have been individually associated with adverse perinatal outcomes related to birthweight and gestational age, but are not often considered in combination. We review types of p ... Full text Link to item Cite

Pharmacoepidemiology of Furosemide in the Neonatal Intensive Care Unit.

Journal Article Neonatology · 2020 BACKGROUND: Furosemide is commonly used off-label in the neonatal intensive care unit (NICU), but current dosing practices vary widely. OBJECTIVES: To describe dosing practices including route, dose, and duration of exposure to furosemide in a large number ... Full text Link to item Cite

Population pharmacokinetics of sildenafil in extremely premature infants.

Journal Article Br J Clin Pharmacol · December 2019 AIMS: To characterize the population pharmacokinetics (PK) of sildenafil and its active metabolite, N-desmethyl sildenafil (DMS), in premature infants. METHODS: We performed a multicentre, open-label trial to characterize the PK of sildenafil in infants ≤2 ... Full text Link to item Cite

Population Pharmacokinetics of Doxycycline in Children.

Journal Article Antimicrob Agents Chemother · September 9, 2019 Doxycycline is a tetracycline-class antimicrobial labeled by the United States (U.S.) Food and Drug Administration for children >8 years of age for many common childhood infections. Doxycycline is not labeled for children ≤8 years of age, due to the associ ... Full text Link to item Cite

Amphotericin B Penetrates into the Central Nervous System Through Focal Disruption of the Blood Brain Barrier in Experimental Hematogenous Candida Meningoencephalitis.

Journal Article Antimicrob Agents Chemother · September 9, 2019 Hematogenous Candida meningoencephalitis (HCME) is a life-threatening complication of neonates and immunocompromised children. Amphotericin B (AmB) shows poor permeability and low cerebrospinal fluid (CSF) concentrations, but is effective in treatment of H ... Full text Link to item Cite

Cefazolin pharmacokinetics in premature infants.

Journal Article J Perinatol · September 2019 OBJECTIVE: Pharmacokinetic (PK) data to guide cefazolin dosing in premature infants are virtually non-existent. Therefore, we aimed to characterize cefazolin PK in infants aged ≤32 weeks of gestation at birth. STUDY DESIGN: We conducted a prospective, open ... Full text Link to item Cite

Dosing and Safety of Off-label Use of Caffeine Citrate in Premature Infants.

Journal Article J Pediatr · August 2019 OBJECTIVE: To characterize the dosing and safety of off-label caffeine citrate in a contemporary cohort of extremely premature infants. STUDY DESIGN: We used electronic health records (2010-2013) from 4 neonatal intensive care units to identify infants of ... Full text Link to item Cite

Physiologically-Based Pharmacokinetic Modeling of Fluconazole Using Plasma and Cerebrospinal Fluid Samples From Preterm and Term Infants.

Conference CPT Pharmacometrics Syst Pharmacol · July 2019 Fluconazole is used to treat hematogenous Candida meningoencephalitis in preterm and term infants. To characterize plasma and central nervous system exposure, an adult fluconazole physiologically-based pharmacokinetic (PBPK) model was scaled to infants, ac ... Full text Link to item Cite

Neonatal Therapeutics: Considerations for Dosing.

Journal Article Am J Perinatol · July 2019 Neonates are a uniquely vulnerable population, compromised by immature physiology and critical illness if born premature. Furthermore, neonates have frequent exposures to drugs that lack adequate data on safety, efficacy, and appropriate dosing in this pop ... Full text Link to item Cite

Rifampin Pharmacokinetics and Safety in Preterm and Term Infants.

Journal Article Antimicrob Agents Chemother · June 2019 Rifampin is active against methicillin-resistant staphylococcal species and tuberculosis (TB). We performed a multicenter, prospective pharmacokinetic (PK) and safety study of intravenous rifampin in infants of <121 days postnatal age (PNA). We enrolled 27 ... Full text Link to item Cite

Furosemide Exposure and Prevention of Bronchopulmonary Dysplasia in Premature Infants.

Journal Article J Pediatr · May 2019 OBJECTIVE: To evaluate the association between furosemide exposure and risk of bronchopulmonary dysplasia (BPD). STUDY DESIGN: This retrospective cohort study included infants (2004-2015) born at 23-29 weeks gestational age and 501-1249 g birth weight. We ... Full text Link to item Cite

Pharmacokinetics of ticarcillin-clavulanate in premature infants.

Journal Article Br J Clin Pharmacol · May 2019 Ticarcillin-clavulanate covers a broad spectrum of pathogens that are common in premature infants. In infants <30 weeks gestational age, pharmacokinetic data to guide ticarcillin-clavulanate dosing are lacking. We enrolled 15 premature infants <30 weeks ge ... Full text Link to item Cite

Safety, Effectiveness and Exposure-response of Micafungin in Infants: Application of an Established Pharmacokinetics Model to Electronic Health Records.

Journal Article Pediatr Infect Dis J · February 2019 Micafungin is used off-label in the United States to treat invasive candidiasis in neonates. We used an established pharmacokinetic model to determine micafungin exposures for 46 courses in 39 hospitalized infants. In this small cohort of infants, micafung ... Full text Link to item Cite

Product Labeling of Drugs Commonly Administered to Children and Adults with Obesity.

Journal Article Pharm Regul Aff · 2019 Obesity is a major public health problem that can affect drug disposition and dosing, particularly in vulnerable pediatric populations. Despite potentially detrimental consequences from inappropriately dosed drugs in children with obesity, drug product lab ... Link to item Cite

Evaluation of Gentamicin Exposure in the Neonatal Intensive Care Unit and Hearing Function at Discharge.

Journal Article J Pediatr · December 2018 OBJECTIVE: To characterize the association between gentamicin dosing, duration of treatment, and ototoxicity in hospitalized infants. STUDY DESIGN: This retrospective cohort study conducted at 330 neonatal intensive care units (2002-2014) included inborn i ... Full text Link to item Cite

Effect of fluconazole prophylaxis on Candida fluconazole susceptibility in premature infants.

Journal Article J Antimicrob Chemother · December 1, 2018 OBJECTIVES: Extremely premature infants are at high risk of developing invasive candidiasis; fluconazole prophylaxis is safe and effective for reducing invasive candidiasis in this population but further study is needed. We sought to better understand the ... Full text Link to item Cite

Association of Atrial Septal Defects and Bronchopulmonary Dysplasia in Premature Infants.

Journal Article J Pediatr · November 2018 OBJECTIVE: To evaluate the association between the presence of an atrial septal defect (ASD) and the odds of developing bronchopulmonary dysplasia (BPD) in premature infants. STUDY DESIGN: We identified a cohort of infants that underwent at least one echoc ... Full text Link to item Cite

Predictors of Prolonged Breast Milk Provision to Very Low Birth Weight Infants.

Journal Article J Pediatr · November 2018 OBJECTIVE: To identify factors associated with prolonged maternal breast milk (BM) provision in very low birth weight (VLBW) infants. STUDY DESIGN: This was a cohort study of VLBW infants who initially received maternal BM and were born at one of 197 neona ... Full text Link to item Cite

Prevalence and safety of diazoxide in the neonatal intensive care unit.

Journal Article J Perinatol · November 2018 OBJECTIVE: Diazoxide is used to treat infants with persistent hypoglycemia, but the prevalence of its use and adverse effects are not well described. We report demographic and clinical characteristics of infants treated with diazoxide in neonatal intensive ... Full text Link to item Cite

Population Pharmacokinetics and Exploratory Exposure-Response Relationships of Diazepam in Children Treated for Status Epilepticus.

Journal Article CPT Pharmacometrics Syst Pharmacol · November 2018 Diazepam is labeled for status epilepticus (SE) in children, but there are limited data characterizing its disposition in pediatric patients. We developed a population pharmacokinetic (PK) model of i.v. diazepam in children with SE. We evaluated relationsh ... Full text Link to item Cite

Voriconazole Treatment for an Infant With Intractable Candida glabrata Meningitis.

Journal Article Pediatr Infect Dis J · October 2018 We report voriconazole levels in an infant with disseminated Candida glabrata infection who received combination antifungal therapy and rescue voriconazole treatment. Serum and cerebrospinal fluid voriconazole levels were higher than anticipated and above ... Full text Link to item Cite

A Population-Based Pharmacokinetic Model Approach to Pantoprazole Dosing for Obese Children and Adolescents.

Journal Article Paediatr Drugs · October 2018 BACKGROUND AND AIMS: Pharmacokinetic data for proton pump inhibitors (PPIs), acid-suppression drugs commonly prescribed to children, are lacking for obese children who are at greatest risk for acid-related disease. In a recent multi-center investigation, w ... Full text Link to item Cite

Prolonged furosemide exposure and risk of abnormal newborn hearing screen in premature infants.

Journal Article Early Hum Dev · October 2018 BACKGROUND: At very high doses, furosemide is linked to ototoxicity in adults, but little is known about the risk of hearing loss in premature infants exposed to furosemide. AIMS: Evaluate the association between prolonged furosemide exposure and abnormal ... Full text Link to item Cite

A Phase 3 Study of Micafungin Versus Amphotericin B Deoxycholate in Infants With Invasive Candidiasis.

Journal Article Pediatr Infect Dis J · October 2018 BACKGROUND: Amphotericin B deoxycholate (AmB-D) is standard of care treatment for neonatal invasive candidiasis (IC). Micafungin (MCA) has broad-spectrum fungicidal activity against Candida spp. We compared the efficacy and safety of intravenous MCA with i ... Full text Link to item Cite

Antifungal Susceptibility and Clinical Outcome in Neonatal Candidiasis.

Journal Article Pediatr Infect Dis J · September 2018 BACKGROUND: Invasive candidiasis is an important cause of sepsis in extremely low birth weight infants (ELBW, < 1000 g), is often fatal, and frequently results in neurodevelopmental impairment (NDI) among survivors. We sought to assess the antifungal minim ... Full text Link to item Cite

Pediatric Antibacterial and Antifungal Trials From 2007 to 2017.

Journal Article Pediatrics · September 2018 BACKGROUND AND OBJECTIVES: The impact of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) on pediatric antibacterial or antifungal drug trials is unknown. Our objective was to identify and characterize trials co ... Full text Open Access Link to item Cite

A directory for neonatal intensive care: potential for facilitating network-based research in neonatology.

Journal Article J Perinatol · August 2018 Directories of contact information have evolved over time from thick paperback times such as the "Yellow Pages" to electronic forms that are searchable and have other functionalities. In our clinical specialty, the development of a professional directory h ... Full text Link to item Cite

Population Pharmacokinetics and Safety of Solithromycin following Intravenous and Oral Administration in Infants, Children, and Adolescents.

Journal Article Antimicrob Agents Chemother · August 2018 Solithromycin is a novel fluoroketolide antibiotic which was under investigation for the treatment of community-acquired bacterial pneumonia (CABP). A phase 1 study was performed to characterize the pharmacokinetics (PK) and safety of solithromycin in chil ... Full text Link to item Cite

A collaborative, academic approach to optimizing the national clinical research infrastructure: The first year of the Trial Innovation Network.

Journal Article J Clin Transl Sci · August 2018 Inefficiencies in the national clinical research infrastructure have been apparent for decades. The National Center for Advancing Translational Science (NCATS) -sponsored CTSA program is able to address such inefficiencies. The Trial Innovation Network (TI ... Full text Link to item Cite

Exposure-Response Analysis of Micafungin in Neonatal Candidiasis: Pooled Analysis of Two Clinical Trials.

Journal Article Pediatr Infect Dis J · June 2018 BACKGROUND: Neonatal candidiasis causes significant morbidity and mortality in high risk infants. The micafungin dosage regimen of 10 mg/kg established for the treatment of neonatal candidiasis is based on a laboratory animal model of neonatal hematogenous ... Full text Link to item Cite

Coordination of the Environmental influences on Child Health Outcomes program: so the whole is greater than the sum of its parts.

Journal Article Curr Opin Pediatr · April 2018 PURPOSE OF REVIEW: The Environmental influences on Child Health Outcomes (ECHO) program's mission is to enhance the health of children for generations to come. In this manuscript, we describe the structure of the ECHO Coordinating Center (ECHO-CC) and its ... Full text Link to item Cite

Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.

Journal Article Contemp Clin Trials Commun · March 2018 Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their ... Full text Link to item Cite

Perceived barriers to pediatrician and family practitioner participation in pediatric clinical trials: Findings from the Clinical Trials Transformation Initiative.

Journal Article Contemp Clin Trials Commun · March 2018 Despite legislation to stimulate pediatric drug development through clinical trials, enrolling children in trials continues to be challenging. Non-investigator (those who have never served as a clinical trial investigator) providers are essential to recrui ... Full text Link to item Cite

Facilitators and barriers to the successful implementation of pediatric antibacterial drug trials: Findings from CTTI's survey of investigators.

Journal Article Contemp Clin Trials Commun · March 2018 An urgent need exists to develop new antibacterial drugs for children. We conducted research with investigators of pediatric antibacterial drug trials to identify facilitators and barriers in the conduct of these trials. Seventy-three investigators complet ... Full text Link to item Cite

Early lumbar puncture and risk of intraventricular hemorrhage in very low birth weight infants.

Journal Article Early Hum Dev · February 2018 BACKGROUND: Lumbar puncture (LP) is the gold standard for diagnosing meningitis; however it is unknown whether early LP (≤3days of life) is associated with increased risk of intraventricular hemorrhage (IVH) in very low birth weight (VLBW) infants. OBJECTI ... Full text Link to item Cite

Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates.

Journal Article Ther Drug Monit · February 2018 BACKGROUND: Dried blood spot (DBS) is a practical sampling strategy for pharmacokinetic studies in neonates. The utility of DBS to determine the population pharmacokinetics (pop-PK) of ampicillin, as well as accuracy versus plasma samples, was evaluated. M ... Full text Link to item Cite

Obese Children Require Lower Doses of Pantoprazole Than Nonobese Peers to Achieve Equal Systemic Drug Exposures.

Journal Article J Pediatr · February 2018 OBJECTIVE: To assess appropriate pantoprazole dosing for obese children, we conducted a prospective pharmacokinetics (PK) investigation of pantoprazole in obese children, a patient population that is traditionally excluded from clinical trials. STUDY DESIG ... Full text Link to item Cite

Effect of renal function on antihypertensive drug safety and efficacy in children.

Journal Article Pediatr Nephrol · January 2018 BACKGROUND: Hypertension and chronic kidney disease (CKD) are common comorbidities. Guidelines recommend treating hypertension in children with CKD because it is a modifiable risk factor for subsequent cardiovascular disease. Children with CKD are frequent ... Full text Link to item Cite

The Need for Pediatric Drug Development.

Journal Article J Pediatr · January 2018 Full text Link to item Cite

Necrotizing Enterocolitis

Chapter · January 1, 2018 Full text Cite

Candida Prophylaxis

Chapter · January 1, 2018 Invasive candidiasis (IC) is a serious infection in hospitalized infants that results in significant mortality and morbidities. Antifungals are used for prophylaxis to decrease the risk of IC. Fluconazole is approved by the US Food and Drug Administration ... Full text Cite

External Evaluation of Two Fluconazole Infant Population Pharmacokinetic Models.

Journal Article Antimicrob Agents Chemother · December 2017 Fluconazole is an antifungal agent used for the treatment of invasive candidiasis, a leading cause of morbidity and mortality in premature infants. Population pharmacokinetic (PK) models of fluconazole in infants have been previously published by Wade et a ... Full text Link to item Cite

Antifungal Extraction by the Extracorporeal Membrane Oxygenation Circuit.

Journal Article J Extra Corpor Technol · September 2017 Invasive candidiasis is common and often fatal in patients supported with extracorporeal membrane oxygenation (ECMO), and treatment relies on optimal antifungal dosing. The ECMO circuit can extract drug and decrease drug exposure, placing the patient at ri ... Link to item Cite

Population Pharmacokinetics and Exploratory Pharmacodynamics of Lorazepam in Pediatric Status Epilepticus.

Journal Article Clin Pharmacokinet · August 2017 BACKGROUND: Lorazepam is one of the preferred agents used for intravenous treatment of status epilepticus (SE). We combined data from two pediatric clinical trials to characterize the population pharmacokinetics of intravenous lorazepam in infants and chil ... Full text Link to item Cite

Timing of Multiorgan Dysfunction among Hospitalized Infants with Fatal Fulminant Sepsis.

Journal Article Am J Perinatol · June 2017 Objective Identify the progression of specific signs of multiorgan dysfunction among infants with fatal sepsis. Study Design Cohort study of 679 infants who died within 3 days of the start of a late-onset sepsis (LOS) episode in neonatal intensive care uni ... Full text Link to item Cite

Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates.

Conference Pediatric research · May 2017 The study of medications among pediatric patients has increased worldwide since 1997 in response to new legislation and regulations, but these studies have not yet adequately addressed the therapeutic needs of neonates. Additionally, extant guidance develo ... Full text Cite

Effectiveness of Granulocyte Colony-Stimulating Factor in Hospitalized Infants with Neutropenia.

Journal Article Am J Perinatol · April 2017 Objective The objective of this study was to determine the time to hematologic recovery and the incidence of secondary sepsis and mortality among neutropenic infants treated or not treated with granulocyte colony-stimulating factor (G-CSF). Study Design We ... Full text Link to item Cite

Safety of High-dose Acyclovir in Infants With Suspected and Confirmed Neonatal Herpes Simplex Virus Infections.

Journal Article Pediatr Infect Dis J · April 2017 BACKGROUND: Acyclovir is used to treat herpes simplex virus disease in infants. Treatment with high-dose acyclovir, 60 mg/kg/d, is recommended; however, the safety of this dosage has not been assessed in the past 15 years, and this dosage is not currently ... Full text Link to item Cite

Pharmacokinetics of Clindamycin in Obese and Nonobese Children.

Journal Article Antimicrob Agents Chemother · April 2017 Although obesity is prevalent among children in the United States, pharmacokinetic (PK) data for obese children are limited. Clindamycin is a commonly used antibiotic that may require dose adjustment in obese children due to its lipophilic properties. We p ... Full text Link to item Cite

Risk factors for group B streptococcal disease in neonates of mothers with negative antenatal testing.

Journal Article J Perinatol · February 2017 OBJECTIVE: The aim of this study was to identify risk factors for early-onset group B Streptococcus (EOGBS) disease in neonates of mothers with negative antenatal screening. STUDY DESIGN: We performed a retrospective cohort study of neonates born to mother ... Full text Link to item Cite

Acute administration of acyl, but not desacyl ghrelin, decreases blood pressure in healthy humans.

Journal Article Eur J Endocrinol · February 2017 OBJECTIVE: To compare the effects of acyl ghrelin (AG) and desacyl ghrelin (DAG) on blood pressure (BP), heart rate (HR) and other autonomic parameters in healthy humans and to elucidate the hormonal mechanisms through which AG could exert its cardiovascul ... Full text Link to item Cite

Intermittent hypoxia during recovery from neonatal hyperoxic lung injury causes long-term impairment of alveolar development: A new rat model of BPD.

Journal Article Am J Physiol Lung Cell Mol Physiol · February 1, 2017 Bronchopulmonary dysplasia (BPD) is a chronic lung injury characterized by impaired alveologenesis that may persist into adulthood. Rat models of BPD using varying degrees of hyperoxia to produce injury either cause early mortality or spontaneously recover ... Full text Link to item Cite

Incidence of Breakthrough Urinary Tract Infection in Hospitalized Infants Receiving Antibiotic Prophylaxis.

Journal Article Clin Pediatr (Phila) · January 2017 Urinary tract infections (UTIs) are a source of substantial morbidity in children in the neonatal intensive care unit. The incidence of UTIs that occur in critically ill infants during a course of antibiotic prophylaxis (i.e., breakthrough urinary tract in ... Full text Link to item Cite

Pharmacokinetics and Safety of Micafungin in Infants Supported With Extracorporeal Membrane Oxygenation.

Journal Article Pediatr Infect Dis J · November 2016 BACKGROUND: Candida is a leading cause of infection in infants on extracorporeal membrane oxygenation (ECMO). Optimal micafungin dosing is unknown in this population because ECMO can alter drug pharmacokinetics (PK). METHODS: To characterize micafungin pha ... Full text Link to item Cite

Electronic Health Records and Pharmacokinetic Modeling to Assess the Relationship between Ampicillin Exposure and Seizure Risk in Neonates.

Journal Article J Pediatr · November 2016 OBJECTIVE: To evaluate the relationship between ampicillin dosing, exposure, and seizures. STUDY DESIGN: This was a retrospective observational cohort study of electronic health record (EHR) data combined with pharmacokinetic model derived drug exposure pr ... Full text Link to item Cite

Fluconazole Prophylaxis for the Prevention of Candidiasis in Premature Infants: A Meta-analysis Using Patient-level Data.

Journal Article Clin Infect Dis · September 1, 2016 BACKGROUND: Invasive candidiasis (IC) is an important cause of sepsis in premature infants and is associated with a high risk of death and neurodevelopmental impairment. Prevention of IC has become a major focus in very low birth weight infants, with fluco ... Full text Link to item Cite

Exposure Matching of Pediatric Anti-infective Drugs: Review of Drugs Submitted to the Food and Drug Administration for Pediatric Approval.

Journal Article Clin Ther · September 2016 PURPOSE: Over the last decade, few new antibiotics have been approved by the Food and Drug Administration (FDA) for pediatric use. For most anti-infective agents, including antibiotics, extrapolation of efficacy from adults to children is possible if the d ... Full text Link to item Cite

Harmonisation in study design and outcomes in paediatric antibiotic clinical trials: a systematic review.

Journal Article Lancet Infect Dis · September 2016 There is no global consensus on the conduct of clinical trials in children and neonates with complicated clinical infection syndromes. No comprehensive regulatory guidance exists for the design of antibiotic clinical trials in neonates and children. We did ... Full text Link to item Cite

Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams.

Journal Article Antimicrob Agents Chemother · September 2016 Fluconazole is an effective agent for prophylaxis of invasive candidiasis in premature infants. The objective of this study was to characterize the population pharmacokinetics (PK) and dosing requirements of fluconazole in infants with birth weights of <75 ... Full text Link to item Cite

Safety of histamine-2 receptor blockers in hospitalized VLBW infants.

Journal Article Early Hum Dev · August 2016 BACKGROUND: Histamine-2 receptor (H2) blockers are often used in very low birth weight infants despite lack of population specific efficacy and safety data. AIMS: We sought to describe safety and temporal trends in histamine-2 receptor (H2) blocker use in ... Full text Link to item Cite

Clindamycin Pharmacokinetics and Safety in Preterm and Term Infants.

Journal Article Antimicrob Agents Chemother · May 2016 Clindamycin may be active against methicillin-resistant Staphylococcus aureus, a common pathogen causing sepsis in infants, but optimal dosing in this population is unknown. We performed a multicenter, prospective pharmacokinetic (PK) and safety study of c ... Full text Link to item Cite

Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents.

Journal Article Antimicrob Agents Chemother · April 2016 We assessed the pharmacokinetics and safety of solithromycin, a fluoroketolide antibiotic, in a phase 1, open-label, multicenter study of 13 adolescents with suspected or confirmed bacterial infections. On days 3 to 5, the mean (standard deviation) maximum ... Full text Link to item Cite

Burden of Invasive Staphylococcus aureus Infections in Hospitalized Infants.

Journal Article JAMA Pediatr · December 2015 IMPORTANCE: Staphylococcus aureus is a frequent cause of infection in hospitalized infants. These infections are associated with increased mortality and morbidity and longer hospital stays, but data on the burden of S aureus disease in hospitalized infants ... Full text Link to item Cite

Postnatal Cytomegalovirus Infection and the Risk for Bronchopulmonary Dysplasia.

Journal Article JAMA Pediatr · December 2015 IMPORTANCE: Postnatally acquired cytomegalovirus (CMV) is typically benign in term infants but in very low-birth-weight (VLBW) infants can cause pneumonitis and sepsislike illness. Whether postnatal CMV infection results in long-term pulmonary sequelae in ... Full text Link to item Cite

Survival Benefit of Empirical Therapy for Staphylococcus aureus Bloodstream Infections in Infants.

Journal Article Pediatr Infect Dis J · November 2015 BACKGROUND: The impact of early adequate empirical antibiotic therapy on outcomes of infants in the neonatal intensive care unit (NICU) who develop Staphylococcus aureus bloodstream infections (BSI) is unknown. METHODS: Infants with S. aureus BSI discharge ... Full text Link to item Cite

Use and Safety of Erythromycin and Metoclopramide in Hospitalized Infants.

Journal Article J Pediatr Gastroenterol Nutr · September 2015 OBJECTIVE: Prokinetic medications are used in premature infants to promote motility and decrease time to full enteral feeding. Erythromycin and metoclopramide are the most commonly used prokinetic medications in the neonatal intensive care unit (NICU), but ... Full text Link to item Cite

Neonatal Escherichia coli Bloodstream Infections: Clinical Outcomes and Impact of Initial Antibiotic Therapy.

Journal Article Pediatr Infect Dis J · September 2015 BACKGROUND: Escherichia coli is a common cause of bloodstream infections (BSIs) in infants and is associated with high mortality and morbidity among survivors. The clinical significance of antibiotic resistance and timing of appropriate antimicrobial thera ... Full text Link to item Cite

Gaps in Drug Dosing for Obese Children: A Systematic Review of Commonly Prescribed Emergency Care Medications.

Journal Article Clin Ther · September 1, 2015 PURPOSE: Approximately 1 of 6 children in the United States is obese. This has important implications for drug dosing and safety because pharmacokinetic (PK) changes are known to occur in obesity due to altered body composition and physiologic mechanisms. ... Full text Link to item Cite

Cefepime and Ceftazidime Safety in Hospitalized Infants.

Journal Article Pediatr Infect Dis J · September 2015 BACKGROUND: Cefepime and ceftazidime are cephalosporins used for the treatment of serious Gram-negative infections. These cephalosporins are used off-label in the setting of minimal safety data for young infants. METHODS: We identified all infants discharg ... Full text Link to item Cite

Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28-29, 2014.

Journal Article Ther Innov Regul Sci · September 2015 The First Annual Neonatal Scientific Workshop focused on the needs of the neonate by addressing the basic question: what information is required to inform decision making both at the regulatory level and at the bedside? Priority therapeutic areas include n ... Full text Link to item Cite

Fluconazole population pharmacokinetics and dosing for prevention and treatment of invasive Candidiasis in children supported with extracorporeal membrane oxygenation.

Journal Article Antimicrob Agents Chemother · July 2015 Candida infections are a leading cause of infectious disease-related death in children supported by extracorporeal membrane oxygenation (ECMO). The ECMO circuit can alter drug pharmacokinetics (PK); thus, standard fluconazole dosing may result in suboptima ... Full text Link to item Cite

Drug Dosing and Pharmacokinetics in Children With Obesity: A Systematic Review.

Journal Article JAMA Pediatr · July 2015 IMPORTANCE: Obesity affects nearly one-sixth of US children and results in alterations to body composition and physiology that can affect drug disposition, possibly leading to therapeutic failure or toxic side effects. The depth of available literature reg ... Full text Link to item Cite

Rifampin use and safety in hospitalized infants.

Journal Article Am J Perinatol · May 2015 OBJECTIVE: This study aims to examine the use and safety of rifampin in the hospitalized infants. STUDY DESIGN: Observational study of clinical and laboratory adverse events among infants exposed to rifampin from 348 neonatal intensive care units managed b ... Full text Link to item Cite

Association of Adverse Pregnancy Outcomes With Glyburide vs Insulin in Women With Gestational Diabetes.

Journal Article JAMA Pediatr · May 2015 IMPORTANCE: Glyburide is thought to be safe for use during pregnancy for treatment of gestational diabetes mellitus (GDM). However, there are limited data on the effectiveness of glyburide when compared with insulin as used in a real-world setting. OBJECTI ... Full text Link to item Cite

Advances in the treatment of invasive neonatal candidiasis.

Journal Article Expert Opin Pharmacother · May 2015 INTRODUCTION: Invasive candidiasis is responsible for ∼ 10% of nosocomial sepsis in very-low-birth-weight infants and is associated with substantial morbidity and mortality. Over the last two decades, the antifungal armamentarium against Candida spp. has i ... Full text Link to item Cite

No survival benefit with empirical vancomycin therapy for coagulase-negative staphylococcal bloodstream infections in infants.

Journal Article Pediatr Infect Dis J · April 2015 BACKGROUND: Coagulase-negative Staphylococcus (CoNS) is the most common cause of bloodstream infections (BSI) in hospitalized infants. CoNS BSI is most reliably treated with vancomycin; however, concerns about side effects and promoting resistance often de ... Full text Link to item Cite

Neonatal-perinatal infections: an update.

Journal Article Clin Perinatol · March 2015 Full text Link to item Cite

The epidemiology and diagnosis of invasive candidiasis among premature infants.

Journal Article Clin Perinatol · March 2015 Invasive candidiasis is a leading infectious cause of morbidity and mortality in premature infants. Improved recognition of modifiable risk factors and antifungal prophylaxis has contributed to the recent decline in the incidence of this infection among in ... Full text Link to item Cite

Population pharmacokinetics of micafungin and its metabolites M1 and M5 in children and adolescents.

Journal Article Antimicrob Agents Chemother · February 2015 The aim of this analysis was to identify therapeutic micafungin regimens for children that produce the same micafungin exposures known to be effective for the prevention and treatment of Candida infections in adults. Pediatric pharmacokinetic data from 229 ... Full text Link to item Cite

ANTIFUNGAL EXTRACTION BY THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT EX VIVO.

Conference CLINICAL PHARMACOLOGY & THERAPEUTICS · February 1, 2015 Link to item Cite

Safety of milrinone use in neonatal intensive care units.

Journal Article Early Hum Dev · January 2015 BACKGROUND: Milrinone use in the neonatal intensive care unit has increased over the last 10 years despite a paucity of published safety data in infants. We sought to determine the safety of milrinone therapy among infants in the neonatal intensive care un ... Full text Link to item Cite

Anaerobic antimicrobial therapy after necrotizing enterocolitis in VLBW infants.

Journal Article Pediatrics · January 2015 OBJECTIVE: To evaluate the effect of anaerobic antimicrobial therapy for necrotizing enterocolitis (NEC) on clinical outcomes in very low birth weight (≤1500 g) infants. METHODS: We identified very low birth weight infants with NEC from 348 US NICUs from 1 ... Full text Link to item Cite

Simultaneous determination of trimethoprim and sulfamethoxazole in dried plasma and urine spots.

Journal Article Bioanalysis · 2015 BACKGROUND: Trimethoprim-sulfamethoxazole (TMP-SMX) is an antimicrobial drug combination commonly prescribed in children and adults. The study objectives were to validate and apply an HPLC-MS/MS method to quantify TMP-SMX in dried plasma spots (DPS) and dr ... Full text Link to item Cite

Career Profile

Journal Article CLINICAL PHARMACOLOGY & THERAPEUTICS · October 1, 2014 Link to item Cite

Advances in pediatric pharmacology, therapeutics, and toxicology.

Journal Article Adv Pediatr · August 2014 In the United States, passage of the FDASIA legislation made BPCA and PREA permanent, no longer requiring reauthorization every 5 years. This landmark legislation also stressed the importance of performing clinical trials in neonates when appropriate. In E ... Full text Link to item Cite

Characterization of the population pharmacokinetics of ampicillin in neonates using an opportunistic study design.

Journal Article Antimicrob Agents Chemother · June 2014 Although ampicillin is the most commonly used drug in neonates, developmental pharmacokinetic (PK) data to guide dosing are lacking. Ampicillin is primarily renally eliminated, and developmental changes are expected to influence PK. We conducted an open-la ... Full text Link to item Cite

Trends in glyburide compared with insulin use for gestational diabetes treatment in the United States, 2000-2011.

Journal Article Obstet Gynecol · June 2014 OBJECTIVE: To describe trends and identify factors associated with choice of pharmacotherapy for gestational diabetes (GDM) from 2000-2011 using a healthcare claims database. METHODS: This was a retrospective cohort study of a large nationwide population o ... Full text Link to item Cite

Pharmacokinetics and pharmacodynamics of antifungals in children: clinical implications.

Journal Article Drugs · June 2014 Invasive fungal disease (IFD) remains life threatening in premature infants and immunocompromised children despite the recent development of new antifungal agents. Optimal dosing of antifungals is one of the few factors clinicians can control to improve ou ... Full text Link to item Cite

Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants: a randomized clinical trial.

Journal Article JAMA · May 7, 2014 IMPORTANCE: Invasive candidiasis in premature infants causes death and neurodevelopmental impairment. Fluconazole prophylaxis reduces candidiasis, but its effect on mortality and the safety of fluconazole are unknown. OBJECTIVE: To evaluate the efficacy an ... Full text Link to item Cite

Developmental pharmacokinetics of piperacillin and tazobactam using plasma and dried blood spots from infants.

Journal Article Antimicrob Agents Chemother · May 2014 Piperacillin-tazobactam is often given to infants with severe infection in spite of limited pharmacokinetics (PK) data. We evaluated piperacillin-tazobactam PK in premature and term infants of ages <61 days with suspected systemic infection. Infants receiv ... Full text Link to item Cite

Fluconazole prophylaxis for prevention of invasive candidiasis in infants.

Journal Article Curr Opin Pediatr · April 2014 PURPOSE OF REVIEW: Invasive candidiasis is a serious infection in hospitalized infants that results in significant mortality and morbidity. Fluconazole is approved by the US Food and Drug Administration for prophylaxis of invasive candidiasis in patients u ... Full text Link to item Cite

Predictors of positive cerebrospinal fluid cultures in infants with bacteremia.

Journal Article Pediatr Infect Dis J · April 2014 BACKGROUND: Meningitis causes substantial morbidity and mortality in hospitalized infants. There is no consensus on the ability of blood cultures to predict results from cerebrospinal fluid (CSF) cultures in hospitalized infants. METHODS: We used the Pedia ... Full text Link to item Cite

Changes in the incidence of candidiasis in neonatal intensive care units.

Journal Article Pediatrics · February 2014 OBJECTIVE: Neonatal invasive candidiasis is associated with significant morbidity and mortality. We describe the association between invasive candidiasis and changes in use of antifungal prophylaxis, empirical antifungal therapy, and broad-spectrum antibac ... Full text Link to item Cite

Pharmacokinetic studies in infants using minimal-risk study designs.

Journal Article Curr Clin Pharmacol · 2014 Infants are therapeutic orphans. Many drugs used in infants are used "off-label", increasing the risk of drug toxicity and suboptimal efficacy in this vulnerable population. This knowledge gap in clinical pharmacology is partly attributed to challenges ass ... Full text Link to item Cite

Intestinal fatty-acid binding protein and metronidazole response in premature infants.

Journal Article J Neonatal Perinatal Med · January 1, 2014 OBJECTIVES: In premature infants with suspected intra-abdominal infection, biomarkers for treatment response to antimicrobial therapy are lacking. Intestinal fatty acid-binding protein (I-FABP) is specific to the enterocyte and is released in response to i ... Full text Link to item Cite

Use of Glyburide vs. Insulin for Treatment of Gestational Diabetes in the US, 2000-2010

Journal Article PHARMACOEPIDEMIOLOGY AND DRUG SAFETY · October 1, 2013 Link to item Cite

Population Pharmacokinetics of Intravenous Acyclovir in Preterm and Term Infants.

Journal Article Pediatr Infect Dis J · September 23, 2013 Acyclovir is used to treat herpes infections in preterm and term infants; however, the influence of maturation on drug disposition and dosing requirements is poorly characterized in this population. ... Full text Link to item Cite

Determining population and developmental pharmacokinetics of metronidazole using plasma and dried blood spot samples from premature infants.

Journal Article Pediatr Infect Dis J · September 2013 BACKGROUND: Limited pharmacokinetic (PK) data of metronidazole in premature infants have led to various dosing recommendations. Surrogate efficacy targets for metronidazole are ill-defined and therefore aimed to exceed minimum inhibitory concentration of o ... Full text Link to item Cite

Adverse events associated with meropenem versus imipenem/cilastatin therapy in a large retrospective cohort of hospitalized infants.

Journal Article Pediatr Infect Dis J · July 2013 BACKGROUND: Carbapenems are commonly used in hospitalized infants despite a lack of complete safety data and associations with seizures in older children. We compared the incidence of adverse events in hospitalized infants receiving meropenem versus imipen ... Full text Link to item Cite

Sildenafil exposure and hemodynamic effect after stage II single-ventricle surgery.

Journal Article Pediatr Crit Care Med · July 2013 OBJECTIVES: To determine sildenafil exposure and hemodynamic effect in children after stage II single-ventricle surgery. DESIGN: Prospective, dose escalation trial. SETTING: Single-center, pediatric catheterization laboratory. PATIENTS: Twelve children pos ... Full text Link to item Cite

Antifungal agents and therapy for infants and children with invasive fungal infections: a pharmacological perspective.

Journal Article Br J Clin Pharmacol · June 2013 Invasive fungal infections, although relatively rare, are life-threatening diseases in premature infants and immunocompromised children. While many advances have been made in antifungal therapeutics in the last two decades, knowledge of the pharmacokinetic ... Full text Link to item Cite

Old and new: appropriate dosing for neonatal antifungal drugs in the nursery.

Journal Article Early Hum Dev · June 2013 Candida infections are a source of significant mortality and morbidity in the neonatal intensive care unit. Treatment strategies continue to change as additional antifungals become available and studies in neonates are performed. Amphotericin B deoxycholat ... Full text Link to item Cite

10 x '20 Progress--development of new drugs active against gram-negative bacilli: an update from the Infectious Diseases Society of America.

Journal Article Clin Infect Dis · June 2013 Infections caused by antibiotic-resistant bacteria, especially the "ESKAPE" pathogens, continue to increase in frequency and cause significant morbidity and mortality. New antimicrobial agents are greatly needed to treat infections caused by gram-negative ... Full text Link to item Cite

Candida pneumonia in a term infant after prolonged use of inhaled corticosteroids for bronchopulmonary dysplasia (BPD).

Journal Article Early Hum Dev · June 2013 Candida spp. frequently cause invasive fungal disease in neonates, and many organs or apparatus can be involved through bloodstream dissemination. Though Candida spp. can heavily colonize the upper and lower respiratory tract, an end-organ localization to ... Full text Link to item Cite

Pharmacological resolution of a multiloculated Candida spp. liver abscess in a preterm neonate.

Journal Article Early Hum Dev · June 2013 We report the case of a 31-week gestational age neonate with Candida albicans sepsis and a hepatic abscess. Diagnosis relied on clinical and radiological signs of sepsis, liver function impairment and culture isolation of Candida spp. from sterile sites. L ... Full text Link to item Cite

Triazole use in the nursery: fluconazole, voriconazole, posaconazole, and ravuconazole.

Journal Article Curr Drug Metab · February 2013 Invasive fungal infections in infants admitted to the neonatal intensive care unit are common and often fatal. The mainstay of therapy against invasive fungal infections is antifungal agents. Over the last two decades, the development and approval of these ... Link to item Cite

Echinocandins for the nursery: an update.

Journal Article Curr Drug Metab · February 2013 As the incidence rates of neonatal invasive fungal infection (IFI) have been increasing over the last years, research efforts have been addressed towards identifying both effective preventative strategies, and efficacious and well-tolerated antifungal drug ... Link to item Cite

Pharmacokinetics of Antimicrobials in Obese Children.

Journal Article GaBI J · 2013 INTRODUCTION: Childhood obesity is common and results in substantial morbidity. The most commonly prescribed drugs in obese children are antibiotics. However, physiologic changes associated with childhood obesity can alter antibiotic pharmacokinetics and o ... Full text Link to item Cite

Recruitment and Retention in Pediatric Clinical Trials: Focus on Pediatric Research Networks in the US and EU

Chapter · January 1, 2013 Pediatric research networks improve the public health of children by ensuring the scientific and ethical implementation of pediatric trials. Some examples of pediatric research networks in the US include the Children's Oncology Group (COG), the Eunice Kenn ... Full text Cite

Sports medicine and ethics.

Journal Article Am J Bioeth · 2013 Physicians working in the world of competitive sports face unique ethical challenges, many of which center around conflicts of interest. Team-employed physicians have obligations to act in the club's best interest while caring for the individual athlete. A ... Full text Link to item Cite

Treatment and prophylaxis of invasive candidiasis.

Journal Article Semin Perinatol · December 2012 Invasive candidiasis (IC) is a leading cause of morbidity and mortality in preterm infants. Even if successfully treated, IC can cause significant neurodevelopmental impairment. Preterm infants are at increased risk for hematogenous Candida meningoencephal ... Full text Link to item Cite

Results from a prospective, international, epidemiologic study of invasive candidiasis in children and neonates.

Journal Article Pediatr Infect Dis J · December 2012 BACKGROUND: Candida species are the third most common cause of pediatric health care-associated bloodstream infection in the United States and Europe. To our knowledge, this report from the International Pediatric Fungal Network is the largest prospective, ... Full text Link to item Cite

Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections.

Journal Article Clin Infect Dis · December 2012 BACKGROUND: Intra-abdominal infections are common in young infants and lead to significant morbidity and mortality. Meropenem is a broad-spectrum antimicrobial with excellent activity against pathogens associated with intra-abdominal infections. The purpos ... Full text Link to item Cite

Very low birth weight neonates who survive early-onset sepsis do not have an increased risk of developing late-onset sepsis.

Journal Article Early Hum Dev · November 2012 BACKGROUND: Very low birth weight neonates (≤ 1500 g, VLBWs) have a high rate of infection and distinct baseline immune function compared with more mature populations. In critically ill children and adults, sepsis increases subsequent infection risk. It is ... Full text Link to item Cite

White paper: recommendations on the conduct of superiority and organism-specific clinical trials of antibacterial agents for the treatment of infections caused by drug-resistant bacterial pathogens.

Journal Article Clin Infect Dis · October 2012 There is a critical need for new pathways to develop antibacterial agents to treat life-threatening infections caused by highly resistant bacteria. Traditionally, antibacterial agents have been studied in noninferiority clinical trials that focus on one si ... Full text Link to item Cite

Pharmacokinetics and safety of fluconazole in young infants supported with extracorporeal membrane oxygenation.

Journal Article Pediatr Infect Dis J · October 2012 BACKGROUND: Candida infections are a leading cause of infectious disease-related death in infants supported with extracorporeal membrane oxygenation (ECMO). The ECMO circuit can alter drug pharmacokinetics; thus, standard fluconazole dosing in children on ... Full text Link to item Cite

Evaluation of a digital microfluidic real-time PCR platform to detect DNA of Candida albicans in blood.

Journal Article Eur J Clin Microbiol Infect Dis · September 2012 Species of Candida frequently cause life-threatening infections in neonates, transplant and intensive care unit (ICU) patients, and others with compromised host defenses. The successful management of systemic candidiasis depends upon early, rapid diagnosis ... Full text Open Access Link to item Cite

Pharmacokinetics and tolerability of single-dose daptomycin in young infants.

Journal Article Pediatr Infect Dis J · September 2012 BACKGROUND: Daptomycin is approved for the treatment of complicated skin and skin-structure infections and Staphylococcus aureus bacteremia. We sought to characterize daptomycin single-dose pharmacokinetics and tolerability in young infants. METHODS: Subje ... Full text Link to item Cite

Candida virulence properties and adverse clinical outcomes in neonatal candidiasis.

Journal Article J Pediatr · September 2012 OBJECTIVE: To determine whether premature infants with invasive Candida infection caused by strains with increased virulence properties have worse clinical outcomes than those infected with less virulent strains. STUDY DESIGN: Clinical isolates were studie ... Full text Link to item Cite

Evidence-based guidelines for pediatric clinical trials: focus on StaR Child Health.

Journal Article Expert Rev Clin Pharmacol · September 2012 Clinical trials in children are challenging and filled with important ethical considerations that differ from adults. Given difficulties associated with pediatric clinical trials, off-label prescribing is a common practice in pediatrics, which can lead to ... Full text Link to item Cite

Empiric antifungal therapy and outcomes in extremely low birth weight infants with invasive candidiasis.

Journal Article J Pediatr · August 2012 OBJECTIVE: To assess the impact of empiric antifungal therapy for invasive candidiasis on subsequent outcomes in premature infants. STUDY DESIGN: This was a cohort study of infants with a birth weight ≤ 1000 g receiving care at Neonatal Research Network si ... Full text Link to item Cite

Use of the complete blood cell count in early-onset neonatal sepsis.

Journal Article Pediatr Infect Dis J · August 2012 BACKGROUND: Early-onset sepsis (EOS) is an important cause of morbidity and mortality in neonates, and its diagnosis remains challenging. The complete blood cell count and differential have been previously evaluated as diagnostic tools for EOS in small, si ... Full text Link to item Cite

Use of the complete blood cell count in late-onset neonatal sepsis.

Journal Article Pediatr Infect Dis J · August 2012 BACKGROUND: Late-onset sepsis is an important cause of morbidity and mortality in infants. Diagnosis of late-onset sepsis can be challenging. The complete blood cell count and differential have been previously evaluated as diagnostic tools for late-onset s ... Full text Link to item Cite

Cytokine profiles of preterm neonates with fungal and bacterial sepsis.

Journal Article Pediatr Res · August 2012 BACKGROUND: Information on cytokine profiles in fungal sepsis (FS), an important cause of mortality in extremely low birthweight (ELBW) infants, is lacking. We hypothesized that cytokine profiles in the first 21 d of life in ELBW infants with FS differ fro ... Full text Open Access Link to item Cite

Therapeutic monitoring of voriconazole in children less than three years of age: a case report and summary of voriconazole concentrations for ten children.

Journal Article Pediatr Infect Dis J · June 2012 Voriconazole is the treatment of choice for invasive aspergillosis and its use is increasing in pediatrics. Minimal pharmacokinetic data exist in young children. We report voriconazole concentrations for 10 children <3 years of age and pharmacokinetic para ... Full text Link to item Cite

Population pharmacokinetics of piperacillin using scavenged samples from preterm infants.

Journal Article Ther Drug Monit · June 2012 OBJECTIVES: Piperacillin is often used in preterm infants for intra-abdominal infections; however, dosing has been derived from small single-center studies excluding extremely preterm infants at a highest risk for these infections. We evaluated the populat ... Full text Link to item Cite

Neonatal fungal infections: when to treat?

Journal Article Early Hum Dev · May 2012 Candida infections are a major cause of morbidity and mortality in neonatal intensive care units. Mortality following Candida bloodstream infections is as high as 40%, and neurodevelopmental impairment is common among survivors. Because invasive fungal inf ... Full text Link to item Cite

Antifungal therapy and outcomes in infants with invasive Candida infections.

Journal Article Pediatr Infect Dis J · May 2012 BACKGROUND: Invasive candidiasis is a leading cause of mortality and morbidity in neonatal intensive care units. Treatment recommendations are limited by a lack of comparative outcomes data. METHODS: We identified all infants ≤ 120 days of age with positiv ... Full text Link to item Cite

Clinical characteristics and response to prophylactic fluconazole of preterm VLBW neonates with baseline and acquired fungal colonisation in NICU: data from a multicentre RCT.

Journal Article Early Hum Dev · May 2012 BACKGROUND: Fungal colonisation by Candida spp. affects a high proportion of VLBW neonates in NICU. However, few data are available on the clinical characteristics of colonisation in preterm infants who are colonised at baseline via vertical transmission, ... Full text Link to item Cite

Early and late onset sepsis in very-low-birth-weight infants from a large group of neonatal intensive care units.

Journal Article Early Hum Dev · May 2012 BACKGROUND: Very-low-birth-weight (VLBW, <1500 g birth weight) infants are at high risk for both early- and late-onset sepsis. Prior studies have observed a predominance of Gram-negative organisms as a cause of early-onset sepsis and Gram-positive organism ... Full text Link to item Cite

Sepsis in young infants with congenital heart disease.

Journal Article Early Hum Dev · May 2012 BACKGROUND: We sought to describe the incidence, pathogen distribution, and mortality associated with blood culture-proven sepsis in young infants with congenital heart disease (CHD) admitted to a neonatal intensive care unit (NICU). METHODS: Cohort study ... Full text Link to item Cite

Very late onset infections in the neonatal intensive care unit.

Journal Article Early Hum Dev · April 2012 OBJECTIVE: We sought to determine the risk factors, incidence, and mortality of very late onset bacterial infection (blood, urine, or cerebrospinal fluid culture positive occurring after day of life 120) in preterm infants. STUDY DESIGN: A retrospective ob ... Full text Link to item Cite

Population pharmacokinetics of metronidazole evaluated using scavenged samples from preterm infants.

Journal Article Antimicrob Agents Chemother · April 2012 Pharmacokinetic (PK) studies in preterm infants are rarely conducted due to the research challenges posed by this population. To overcome these challenges, minimal-risk methods such as scavenged sampling can be used to evaluate the PK of commonly used drug ... Full text Link to item Cite

The use of antifungal therapy in neonatal intensive care.

Journal Article Clin Perinatol · March 2012 Invasive fungal infections remain a significant cause of infection-related mortality and morbidity in preterm infants. Central nervous system involvement is the hallmark of neonatal candidiasis, differentiating the disease's impact on young infants from th ... Full text Link to item Cite

Outcomes following candiduria in extremely low birth weight infants.

Journal Article Clin Infect Dis · February 1, 2012 BACKGROUND: Candidiasis carries a significant risk of death or neurodevelopmental impairment (NDI) in extremely low birth weight infants (ELBW; <1000 g). We sought to determine the impact of candiduria in ELBW preterm infants. METHODS: Our study was a seco ... Full text Link to item Cite

Pharmacokinetics of moxifloxacin in an infant with Mycoplasma hominis meningitis.

Journal Article Pediatr Infect Dis J · February 2012 Treatment of Mycoplasma hominis meningitis in infants is limited by a lack of consensus regarding therapy and limited pharmacokinetic data for agents to which M. hominis is susceptible. We report the successful treatment of a premature infant suffering fro ... Full text Link to item Cite

Anidulafungin for neonatal hematogenous Candida meningoencephalitis: identification of candidate regimens for humans using a translational pharmacological approach.

Journal Article Antimicrob Agents Chemother · February 2012 Hematogenous Candida meningoencephalitis (HCME) is a serious infection in premature neonates. Anidulafungin is an echinocandin antifungal agent with potent activity against Candida spp., but its efficacy and optimal regimens for human neonates with HCME ar ... Full text Link to item Cite

Necrotizing Enterocolitis

Chapter · January 1, 2012 Full text Cite

Fluconazole pharmacokinetics and safety in premature infants.

Journal Article Curr Med Chem · 2012 Invasive candidiasis (IC) in the premature infant population is a common infection that results in substantial morbidity and mortality. For these patients, fluconazole is among the first line therapies to treat and prevent IC, and yet few prospective studi ... Full text Link to item Cite

Development of a liquid chromatography-tandem mass spectrometry assay of six antimicrobials in plasma for pharmacokinetic studies in premature infants.

Journal Article J Chromatogr B Analyt Technol Biomed Life Sci · November 15, 2011 This method provides a simple extraction procedure, as well as a validated, sensitive, and specific liquid chromatography-tandem mass spectrometry assay for the simultaneous quantification of ampicillin, piperacillin, tazobactam, meropenem, acyclovir, and ... Full text Link to item Cite

Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid of infants with suspected or complicated intra-abdominal infections.

Journal Article Pediatr Infect Dis J · October 2011 Featured Publication BACKGROUND: Suspected or complicated intra-abdominal infections are common in young infants and lead to significant morbidity and mortality. Meropenem is a broad-spectrum antimicrobial agent with excellent activity against pathogens associated with intra-a ... Full text Link to item Cite

Innovative clinical trial design for pediatric therapeutics.

Journal Article Expert Rev Clin Pharmacol · September 2011 Until approximately 15 years ago, sponsors rarely included children in the development of therapeutics. US and European legislation has resulted in an increase in the number of pediatric trials and specific label changes and dosing recommendations, althoug ... Full text Link to item Cite

Pediatric cardiovascular drug dosing in critically ill children and extracorporeal membrane oxygenation.

Journal Article J Cardiovasc Pharmacol · August 2011 Cardiovascular disease in children is common and results in significant morbidity and mortality. The sickest children with cardiovascular disease may require support with extracorporeal membrane oxygenation (ECMO), which provides life-saving assistance for ... Full text Link to item Cite

Coagulase-negative staphylococcal infections in the neonatal intensive care unit.

Journal Article Infect Control Hosp Epidemiol · July 2011 Featured Publication BACKGROUND: Coagulase-negative staphylococci (CoNS) are the most commonly isolated pathogens in the neonatal intensive care unit (NICU). CoNS infections are associated with increased morbidity, including neurodevelopmental impairment. OBJECTIVE: To describ ... Full text Link to item Cite

Repeat lumbar punctures in infants with meningitis in the neonatal intensive care unit.

Journal Article J Perinatol · June 2011 Featured Publication OBJECTIVE: The purpose of this study is to examine the results of repeat lumbar puncture in infants with initial positive cerebrospinal fluid (CSF) cultures in order to determine the clinical characteristics and outcomes of infants with repeat positive cul ... Full text Link to item Cite

Safety and pharmacokinetics of multiple-dose anidulafungin in infants and neonates.

Journal Article Clin Pharmacol Ther · May 2011 Featured Publication Candida infections are common and often fatal in infants and neonates. Anidulafungin has excellent activity against Candida species, but the pharmacokinetics (PK) and safety of the drug in infants and neonates are unknown. The object of our study was to de ... Full text Link to item Cite

Fluconazole loading dose pharmacokinetics and safety in infants.

Journal Article Pediatr Infect Dis J · May 2011 Featured Publication BACKGROUND: Invasive candidiasis is a leading cause of morbidity and mortality in critically ill infants. Prompt administration of fluconazole and achievement of the therapeutic target (area under the curve 0 to 24 hours >400 mg*h/L) improve outcomes in ca ... Full text Link to item Cite

Higher clearance of micafungin in neonates compared with adults: role of age-dependent micafungin serum binding.

Journal Article Biopharm Drug Dispos · May 2011 Featured Publication Micafungin, a new echinocandin antifungal agent, has been used widely for the treatment of various fungal infections in human populations. Micafungin is predominantly cleared by biliary excretion and it binds extensively to plasma proteins. Micafungin body ... Full text Link to item Cite

Center variation in patient age and weight at Fontan operation and impact on postoperative outcomes.

Journal Article Ann Thorac Surg · May 2011 BACKGROUND: The impact of age and weight on outcomes after the Fontan operation is unclear. Previous analyses have suggested that lower weight-for-age z-score is an important predictor of poor outcome in patients undergoing bidirectional Glenn. We evaluate ... Full text Link to item Cite

Safety of micafungin in infants: insights into optimal dosing.

Journal Article Expert Opin Drug Saf · March 2011 INTRODUCTION: Invasive Candida infections are a leading cause of mortality and morbidity in neonatal intensive care units (NICUs). Micafungin is a promising therapeutic option for treatment of invasive fungal infections in infants given its safety profile ... Full text Link to item Cite

Pharmacokinetics of antifungal agents in children.

Journal Article Early Hum Dev · March 2011 Invasive fungal infections in immunocompromised children are common and often fatal. The first antifungal agents such as amphotericin B and fluconazole offered effective treatment, but their use was often limited by toxicity and resistance. Numerous new an ... Full text Link to item Cite

Choosing the right empirical antibiotics for neonates.

Journal Article Arch Dis Child Fetal Neonatal Ed · January 2011 Full text Link to item Cite

In reply

Journal Article Pediatrics · January 1, 2011 Full text Cite

Neonatal candidiasis: epidemiology, risk factors, and clinical judgment.

Journal Article Pediatrics · October 2010 Featured Publication OBJECTIVE: Invasive candidiasis is a leading cause of infection-related morbidity and mortality in extremely low birth weight (<1000-g) infants. We quantified risk factors that predict infection in premature infants at high risk and compared clinical judgm ... Full text Link to item Cite

In vitro investigation of the hepatobiliary disposition mechanisms of the antifungal agent micafungin in humans and rats.

Journal Article Drug Metab Dispos · October 2010 The purpose of the present study was to elucidate the transport mechanisms responsible for elimination of micafungin, a new semisynthetic echinocandin antifungal agent, which is predominantly cleared by biliary excretion in humans and rats. In vitro studie ... Full text Link to item Cite

Role of echinocandins in the management of fungal infections in neonates.

Journal Article J Matern Fetal Neonatal Med · October 2010 As the incidence rates of neonatal systemic fungal infections (SFI) have been increasing over the last years, research efforts have been addressed towards identifying both effective preventative strategies, and efficacious and well-tolerated antifungal dru ... Full text Link to item Cite

Globalization of pediatric research: analysis of clinical trials completed for pediatric exclusivity.

Journal Article Pediatrics · September 2010 OBJECTIVE: We evaluated the setting of published studies conducted under the US Pediatric Exclusivity Provision, which provides economic incentives to pharmaceutical companies to conduct drug studies with children. METHODS: Published studies containing the ... Full text Link to item Cite

Risk factors and prevention of late-onset sepsis in premature infants.

Journal Article Early Hum Dev · July 2010 Late-onset sepsis in premature infants is a major cause of morbidity, mortality, and increased medical costs. Risk factors include low birth weight, low gestational age, previous antimicrobial exposure, poor hand hygiene, and central venous catheters. Meth ... Full text Link to item Cite

Population pharmacokinetics of micafungin in neonates and young infants.

Journal Article Antimicrob Agents Chemother · June 2010 Featured Publication Micafungin is an echinocandin with potent activity against Candida spp. Hematogenous Candida meningoencephalitis (HCME) is a frequent complication of disseminated Candida infection in premature infants. A preclinical model of HCME suggests that micafungin ... Full text Link to item Cite

Cough in pediatric patients receiving angiotensin-converting enzyme inhibitor therapy or angiotensin receptor blocker therapy in randomized controlled trials.

Journal Article Clin Pharmacol Ther · June 2010 The incidence of cough in children receiving antihypertension therapy with angiotensin-converting enzyme inhibitors (ACEis) or angiotensin receptor blockers (ARBs) is unknown. We analyzed patient-level data from eight randomized trials for the treatment of ... Full text Link to item Cite

Examination of type IV pilus expression and pilus-associated phenotypes in Kingella kingae clinical isolates.

Journal Article Infect Immun · April 2010 Kingella kingae is a gram-negative bacterium that is being recognized increasingly as a cause of septic arthritis and osteomyelitis in young children. Previous work established that K. kingae expresses type IV pili that mediate adherence to respiratory epi ... Full text Link to item Cite

Outcomes of catheter-associated infections in pediatric patients with short bowel syndrome.

Journal Article J Pediatr Gastroenterol Nutr · April 2010 Featured Publication Children with short bowel syndrome requiring long-term total parenteral nutrition are at high risk for catheter-associated infections. The optimal management of catheter infections in this patient population is unknown. We conducted a retrospective observa ... Full text Link to item Cite

Prevalence of renal anomalies after urinary tract infections in hospitalized infants less than 2 months of age.

Journal Article J Perinatol · April 2010 OBJECTIVE: Our aim was to determine the incidence of anatomical abnormalities after a urinary tract infection (UTI) in infants <2 months of age hospitalized in the neonatal intensive care unit (NICU). STUDY DESIGN: This was a retrospective, single-center c ... Full text Open Access Link to item Cite

Major infection after pediatric cardiac surgery: a risk estimation model.

Journal Article Ann Thorac Surg · March 2010 BACKGROUND: In pediatric cardiac surgery, infection is a leading cause of morbidity and mortality. We created a model to predict risk of major infection in this population. METHODS: Using the Society of Thoracic Surgeons Congenital Heart Surgery Database, ... Full text Link to item Cite

Recent Advances in the Detection of Neonatal Candidiasis.

Journal Article Curr Fungal Infect Rep · March 1, 2010 Neonatal candidiasis is serious and often fatal. Blood culture, the standard for diagnosis, has a sensitivity of 50% or less, and isolate speciation and susceptibility takes several days. This review explores recent advances in Candida detection using vari ... Full text Link to item Cite

Comparison of costs, length of stay, and mortality associated with Candida glabrata and Candida albicans bloodstream infections.

Journal Article Am J Infect Control · February 2010 We compared costs, length of stay, and mortality between adults with Candida albicans and Candida glabrata bloodstream infections. Early evidence of C glabrata, as defined by a positive culture within 2 days of admission, was associated with higher costs ( ... Full text Link to item Cite

Cross-reactive immunologic material status affects treatment outcomes in Pompe disease infants.

Journal Article Mol Genet Metab · January 2010 Deficiency of acid alpha glucosidase (GAA) causes Pompe disease, which is usually fatal if onset occurs in infancy. Patients synthesize a non-functional form of GAA or are unable to form native enzyme. Enzyme replacement therapy with recombinant human GAA ... Full text Link to item Cite

Safety and pharmacokinetics of repeat-dose micafungin in young infants.

Journal Article Clin Pharmacol Ther · January 2010 Featured Publication Given the risk of central nervous system infection, relatively high weight-based echinocandin dosages may be required for the successful treatment of invasive candidiasis and candidemia in young infants. This open-label study assessed the safety and pharma ... Full text Link to item Cite

In vitro hepatic metabolism explains higher clearance of voriconazole in children versus adults: role of CYP2C19 and flavin-containing monooxygenase 3.

Journal Article Drug Metab Dispos · January 2010 Voriconazole is a broad spectrum antifungal agent for treating life-threatening fungal infections. Its clearance is approximately 3-fold higher in children compared with adults. Voriconazole is cleared predominantly via hepatic metabolism in adults, mainly ... Full text Link to item Cite

Treatment of neonatal fungal infections.

Journal Article Adv Exp Med Biol · 2010 Full text Link to item Cite

Pediatric antifungal agents.

Journal Article Curr Opin Infect Dis · December 2009 PURPOSE OF REVIEW: In immunocompromised hosts, invasive fungal infections are common and fatal. In the past decade, the antifungal armamentarium against invasive mycoses has expanded greatly. The purpose of the present report is to review the most recent l ... Full text Link to item Cite

Clinical trial design in neonatal pharmacology: effect of center differences, with lessons from the Pediatric Oncology Cooperative Research experience.

Journal Article Clin Pharmacol Ther · December 2009 Survival for premature neonates has improved dramatically over the past 20 years; however, there has been minimal improvement in prematurity-associated morbidities. Morbidity rates and assessment of outcomes vary across neonatology intensive care units (NI ... Full text Link to item Cite

Safety and transparency of pediatric drug trials.

Journal Article Arch Pediatr Adolesc Med · December 2009 OBJECTIVES: To quantify the frequency and type of new safety information arising from studies performed under the auspices of the Pediatric Exclusivity Program, to describe the dissemination of these findings in the peer-reviewed literature and compare thi ... Full text Link to item Cite

Early and late onset sepsis in late preterm infants.

Journal Article Pediatr Infect Dis J · December 2009 BACKGROUND: Preterm birth is increasing worldwide, and late preterm births, which comprise more than 70% of all preterm births, account for much of the increase. Early and late onset sepsis results in significant mortality in extremely preterm infants, but ... Full text Link to item Cite

Management of neonatal candidiasis

Journal Article Journal of Invasive Fungal Infections · December 1, 2009 Invasive candidiasis (IC) is common and often fatal in extremely premature neonates. In the last decade, the therapeutic armamentarium for IC has markedly expanded; however, the pharmacokinetics, safety and efficacy of most antifungal agents in premature n ... Cite

Group B streptococcal meningitis: cerebrospinal fluid parameters in the era of intrapartum antibiotic prophylaxis.

Journal Article Early Hum Dev · October 2009 OBJECTIVE: Describe cerebrospinal fluid parameters in infants with culture-proven Group B streptococcal meningitis in the era of intrapartum antibiotic prophylaxis. STUDY DESIGN: Cohort study of the first lumbar puncture from 13,495 infants cared for at 15 ... Full text Link to item Cite

Zygomycosis in neonates: an uncommon but life-threatening infection.

Journal Article Am J Perinatol · September 2009 We systematically reviewed all published cases of zygomycosis, an increasingly important infection with high mortality, in neonates. We searched PubMed and individual references for English publications of single cases or case series of neonatal (0 to 1 mo ... Full text Link to item Cite

Fluconazole dosing for the prevention or treatment of invasive candidiasis in young infants.

Journal Article Pediatr Infect Dis J · August 2009 Featured Publication BACKGROUND: Young infants are susceptible to developmental factors influencing the pharmacokinetics of drugs. Fluconazole is increasingly used to prevent and treat invasive candidiasis in infants. Dosing guidance remains empiric and variable because limite ... Full text Link to item Cite

Total lymphocyte count and World Health Organization pediatric clinical stage as markers to assess need to initiate antiretroviral therapy among human immunodeficiency virus-infected children in Moshi, Northern Tanzania.

Journal Article Pediatr Infect Dis J · June 2009 BACKGROUND: The World Health Organization (WHO) has recommended the use of clinical staging alone and with total lymphocyte count to identify HIV infected children in need of antiretroviral therapy (ART) in resource-limited settings, when CD4 cell count is ... Full text Link to item Cite

Pharmacokinetics of an elevated dosage of micafungin in premature neonates.

Journal Article Pediatr Infect Dis J · May 2009 Featured Publication BACKGROUND: Determining the safety and pharmacokinetics of antifungal agents in neonates is important. A previous single-dose pharmacokinetic study of micafungin in neonates demonstrated that doses of 0.75 to 3 mg/kg produced lower plasma micafungin concen ... Full text Link to item Cite

Candida albicans and non-albicans bloodstream infections in adult and pediatric patients: comparison of mortality and costs.

Journal Article Pediatr Infect Dis J · May 2009 We compared length of stay, inpatient costs, and mortality associated with Candida albicans and non-albicans bloodstream infections in adults and children. Compared with adults, children with Candida bloodstream infections had longer lengths of stay (36.7 ... Full text Link to item Cite

Immunotherapy in neonatal sepsis: advances in treatment and prophylaxis.

Journal Article Curr Opin Pediatr · April 2009 PURPOSE OF REVIEW: Systemic infections in premature and term infants cause significant morbidity and mortality in spite of appropriate antimicrobial therapy. Consequently, immunotherapy has emerged as a potential adjuvant therapeutic modality to reduce the ... Full text Link to item Cite

Effect of methicillin-resistant Staphylococcus aureus colonization in the neonatal intensive care unit on total hospital cost.

Journal Article Infect Control Hosp Epidemiol · April 2009 The rate of methicillin-resistant Staphylococcus aureus (MRSA) infection is increasing in neonatal intensive care units. We determined the economic impact of isolating and cohorting MRSA-colonized neonates on total hospital cost at a 49-bed, level III-IV n ... Full text Link to item Cite

Clinical practice guidelines for the management of candidiasis: 2009 update by the Infectious Diseases Society of America.

Journal Article Clin Infect Dis · March 1, 2009 Featured Publication Guidelines for the management of patients with invasive candidiasis and mucosal candidiasis were prepared by an Expert Panel of the Infectious Diseases Society of America. These updated guidelines replace the previous guidelines published in the 15 January ... Full text Link to item Cite

Staphylococcus aureus bacteremia among patients with health care-associated fever.

Journal Article Am J Med · March 2009 BACKGROUND: Although Staphylococcus aureus bacteremia is a common, serious infection, accurately identifying febrile patients with this diagnosis at the time of initial evaluation is difficult. The purpose of this investigation was to define clinical chara ... Full text Link to item Cite

Necrotizing Enterocolitis

Chapter · January 1, 2009 Full text Cite

Prolonged duration of initial empirical antibiotic treatment is associated with increased rates of necrotizing enterocolitis and death for extremely low birth weight infants.

Journal Article Pediatrics · January 2009 Featured Publication OBJECTIVES: Our objectives were to identify factors associated with the duration of the first antibiotic course initiated in the first 3 postnatal days and to assess associations between the duration of the initial antibiotic course and subsequent necrotiz ... Full text Link to item Cite

Traumatic lumbar punctures in neonates: test performance of the cerebrospinal fluid white blood cell count.

Journal Article Pediatr Infect Dis J · December 2008 Featured Publication BACKGROUND: Cerebrospinal fluid (CSF) findings are often used to diagnose meningitis in neonates given antibiotics before the lumbar puncture is performed. Traumatic lumbar punctures are common and complicate interpretation of CSF white blood cell counts. ... Full text Link to item Cite

Population pharmacokinetics of fluconazole in young infants.

Journal Article Antimicrob Agents Chemother · November 2008 Featured Publication Fluconazole is being increasingly used to prevent and treat invasive candidiasis in neonates, yet dosing is largely empirical due to the lack of adequate pharmacokinetic (PK) data. We performed a multicenter population PK study of fluconazole in 23- to 40- ... Full text Link to item Cite

Arrhythmias in patients receiving enzyme replacement therapy for infantile Pompe disease.

Journal Article Genet Med · October 2008 PURPOSE: Enzyme replacement therapy in infants with Pompe disease prolongs survival, decreases cardiomegaly, and improves muscle function. Because ectopy has been previously described in these patients, we sought to determine the prevalence and types of ar ... Full text Link to item Cite

The economic returns of pediatric clinical trials of antihypertensive drugs.

Journal Article Am Heart J · October 2008 BACKGROUND: Congress has authorized the United States Food and Drug Administration (FDA) to provide industry sponsors with a 6-month extension of drug marketing rights under the Pediatric Exclusivity Provision if FDA-requested pediatric drug trials are con ... Full text Link to item Cite

The endotracheal tube air leak test does not predict extubation outcome in critically ill pediatric patients.

Journal Article Pediatr Crit Care Med · September 2008 OBJECTIVE: Endotracheal tube air leak pressures are used to predict postextubation upper airway compromise such as stridor, upper airway obstruction, or risk of reintubation. To determine whether the absence of an endotracheal tube air leak (air leak test ... Full text Link to item Cite

Safety monitoring of drugs receiving pediatric marketing exclusivity.

Journal Article Pediatrics · September 2008 OBJECTIVES: The Food and Drug Administration Modernization Act provided for an additional 6-month period of marketing exclusivity to companies that perform pediatric drug trials in response to a Food and Drug Administration-issued written request. Because ... Full text Link to item Cite

Racial differences in blood pressure response to angiotensin-converting enzyme inhibitors in children: a meta-analysis.

Journal Article Clin Pharmacol Ther · September 2008 Angiotensin-converting enzyme (ACE) inhibitors are frequently used to treat hypertension in children.(1) ACE inhibitors alter the balance between the vasoconstrictive, salt-retentive, and cardiac hypertrophic properties of angiotensin II and the vasodilato ... Full text Link to item Cite

Is an increased dwell time of a peripherally inserted catheter associated with an increased risk of bloodstream infection in infants?

Journal Article Infect Control Hosp Epidemiol · August 2008 OBJECTIVE: To estimate the risk of bloodstream infection associated with catheter dwell time in infants. DESIGN: Retrospective study. SETTING: Duke University Medical Center neonatal intensive care unit, an academic, level 3 nursery in Durham, North Caroli ... Full text Link to item Cite

Meningitis in preterm neonates: importance of cerebrospinal fluid parameters.

Journal Article Am J Perinatol · August 2008 Cerebrospinal fluid parameters are of great importance in diagnosing meningitis, but normal values for preterm neonates are based on small, single-center studies. We sought to determine current values for preterm neonate cerebrospinal fluid parameters and ... Full text Link to item Cite

Candida infective endocarditis.

Journal Article Eur J Clin Microbiol Infect Dis · July 2008 Candida infective endocarditis (IE) is uncommon but often fatal. Most epidemiologic data are derived from small case series or case reports. This study was conducted to explore the epidemiology, treatment patterns, and outcomes of patients with Candida IE. ... Full text Link to item Cite

Role of flavin-containing monooxygenase in oxidative metabolism of voriconazole by human liver microsomes.

Journal Article Drug Metab Dispos · June 2008 Voriconazole is a potent second-generation triazole antifungal agent with broad-spectrum activity against clinically important fungi. It is cleared predominantly via metabolism in all species tested including humans. N-Oxidation of the fluoropyrimidine rin ... Full text Link to item Cite

First, do no harm.

Journal Article Pediatrics · April 2008 Full text Link to item Cite

Safety of placebo controls in pediatric hypertension trials.

Journal Article Hypertension · April 2008 Featured Publication Many clinical trials, including those in pediatric populations, use a placebo arm for medical conditions for which there are readily available therapeutic interventions. Several short-term efficacy trials of antihypertensive medications performed in respon ... Full text Link to item Cite

AAV vector-mediated reversal of hypoglycemia in canine and murine glycogen storage disease type Ia.

Journal Article Mol Ther · April 2008 Glycogen storage disease type Ia (GSD-Ia) profoundly impairs glucose release by the liver due to glucose-6-phosphatase (G6Pase) deficiency. An adeno-associated virus (AAV) containing a small human G6Pase transgene was pseudotyped with AAV8 (AAV2/8) to opti ... Full text Link to item Cite

Pediatric antihypertensive trial failures: analysis of end points and dose range.

Journal Article Hypertension · April 2008 Featured Publication Historically, drugs prescribed for children have not been studied in pediatric populations. Since 1997, however, a 6-month extension of marketing rights is granted if manufacturers conduct Food and Drug Administration-defined pediatric trials. In nearly ha ... Full text Link to item Cite

Daptomycin use in infants: report of two cases with peak and trough drug concentrations.

Journal Article J Perinatol · March 2008 We report two infants treated with daptomycin for methicillin-resistant Staphylococcus aureus infection and describe peak and trough blood concentrations measured during therapy. The peak concentrations were 41.7 and 36.7 mcg ml(-1), and the 12-hour trough ... Full text Link to item Cite

Venous thrombosis in patients with short- and long-term central venous catheter-associated Staphylococcus aureus bacteremia.

Journal Article Crit Care Med · February 2008 OBJECTIVE: Infection and thrombosis are important complications of intravascular catheters. The purpose of this study was to determine the incidence of thrombosis in patients with central venous catheter-associated Staphylococcus aureus bacteremia and the ... Full text Link to item Cite

The pharmacokinetics and pharmacodynamics of micafungin in experimental hematogenous Candida meningoencephalitis: implications for echinocandin therapy in neonates.

Journal Article J Infect Dis · January 1, 2008 Featured Publication BACKGROUND: Hematogenous Candida meningoencephalitis (HCME) is a relatively frequent manifestation of disseminated candidiasis in neonates and is associated with significant mortality and neurodevelopmental abnormalities. The outcome after antifungal thera ... Full text Link to item Cite

Association between thrombosis and bloodstream infection in neonates with peripherally inserted catheters.

Journal Article Thromb Res · 2008 INTRODUCTION: Peripherally inserted catheters are essential for infants in the neonatal intensive care nursery for administration of medications, parenteral nutrition and blood transfusions. We hypothesized that there is an association between catheter ass ... Full text Link to item Cite

Epidemiology of respiratory syncytial virus in various regions within North Carolina during multiple seasons.

Journal Article North Carolina medical journal · 2008 BACKGROUND: The Centers for Disease Control and Prevention (CDC) monitors the occurrence of respiratory syncytial virus (RSV) in the United States and has historically reported on activity at the regional level. Prior to the 2007-2008 RSVseason, the CDC di ... Cite

Non-HACEK gram-negative bacillus endocarditis.

Journal Article Ann Intern Med · December 18, 2007 BACKGROUND: Infective endocarditis caused by non-HACEK (species other than Haemophilus species, Actinobacillus actinomycetemcomitans, Cardiobacterium hominis, Eikenella corrodens, or Kingella species) gram-negative bacilli is rare, is poorly characterized, ... Full text Link to item Cite

Mortality and neurodevelopmental outcome after Staphylococcus aureus bacteremia in infants.

Journal Article Pediatr Infect Dis J · December 2007 Featured Publication We compared outcomes in infants with methicillin-resistant and methicillin-sensitive Staphylococcus aureus bacteremia. Infants with methicillin-resistant S. aureus infection had a longer median duration of bacteremia (4.5 versus 1 day, P = 0.01), but no di ... Full text Link to item Cite

Predictive value of cerebrospinal fluid parameters in neonates with intraventricular drainage devices.

Journal Article J Neurosurg · September 2007 Featured Publication OBJECT: Infection is a common and potentially devastating complication following placement of ventriculoperitoneal (VP) shunts and cerebrospinal fluid (CSF) reservoirs in neonates. The goal of this study was to determine the normal ranges for cell count pa ... Full text Link to item Cite

Quantification of 1,3-beta-D-glucan levels in children: preliminary data for diagnostic use of the beta-glucan assay in a pediatric setting.

Journal Article Clin Vaccine Immunol · July 2007 1,3-Beta-D-Glucan serum levels have demonstrated good diagnostic sensitivity and specificity for the diagnosis of candidiasis in adult patients, but normal levels for children have not been established. We found higher 1,3-beta-D-glucan levels in children ... Full text Link to item Cite

Successful medical treatment of cutaneous aspergillosis in a premature infant using liposomal amphotericin B, voriconazole and micafungin.

Journal Article Pediatr Infect Dis J · April 2007 Treatment options for primary cutaneous aspergillosis in neonates are limited by the lack of pharmacokinetic and safety data of newer antifungal agents that are effective against Aspergillus spp. We report the successful treatment of cutaneous aspergillosi ... Full text Link to item Cite

Excess costs of hospital care associated with neonatal candidemia.

Journal Article Pediatr Infect Dis J · March 2007 BACKGROUND: Nosocomial bloodstream infections are associated with increased hospital costs in adult and pediatric patients. Candida is an increasingly important nosocomial pathogen within intensive care nurseries. The purpose of this study was to determine ... Full text Link to item Cite

Economic return of clinical trials performed under the pediatric exclusivity program.

Journal Article JAMA · February 7, 2007 Featured Publication CONTEXT: In 1997, Congress authorized the US Food and Drug Administration (FDA) to grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program if industry sponsors complete FDA-requested pediatric trials. The program has been pra ... Full text Open Access Link to item Cite

Caspofungin for the treatment of azole resistant candidemia in a premature infant.

Journal Article J Perinatol · February 2007 Candidemia is common in extremely low birth weight infants and is associated with substantial mortality and morbidity. Treatment options have traditionally been limited to amphotericin B deoxycholate or fluconazole. We present a case of a premature infant ... Full text Link to item Cite

Neonatal Candida meningitis: significance of cerebrospinal fluid parameters and blood cultures.

Journal Article J Perinatol · February 2007 Featured Publication OBJECTIVE: The purpose of this study was to examine the frequency of normal cerebrospinal fluid (CSF) parameters in Candida meningitis and the proportion of candidemia associated with Candida meningitis. STUDY DESIGN: We evaluated the initial lumbar punctu ... Full text Link to item Cite

Use of vancomycin or first-generation cephalosporins for the treatment of hemodialysis-dependent patients with methicillin-susceptible Staphylococcus aureus bacteremia.

Journal Article Clin Infect Dis · January 15, 2007 BACKGROUND: Because of its ease of dosing, vancomycin is commonly used to treat methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia in patients undergoing long-term hemodialysis. Clinical outcomes resulting from such a therapeutic strategy have ... Full text Link to item Cite

Infection in late preterm infants.

Journal Article Clin Perinatol · December 2006 Late preterm neonates have unique susceptibilities to infection. The closed setting of the neonatal ICU (NICU) and the immunologic immaturity of premature infants set the state for the development of nosocomial infections. This article discusses infections ... Full text Link to item Cite

Enhanced efficacy of an AAV vector encoding chimeric, highly secreted acid alpha-glucosidase in glycogen storage disease type II.

Journal Article Mol Ther · December 2006 Glycogen storage disease type II (GSD-II; Pompe disease; MIM 232300) is an inherited muscular dystrophy caused by deficiency in the activity of the lysosomal enzyme acid alpha-glucosidase (GAA). We hypothesized that chimeric GAA containing an alternative s ... Full text Link to item Cite

Peer-reviewed publication of clinical trials completed for pediatric exclusivity.

Journal Article JAMA · September 13, 2006 Featured Publication CONTEXT: Much of pediatric drug use is off-label because appropriate pediatric studies have not been conducted and the drugs have not been labeled by the US Food and Drug Administration (FDA) for use in children. In 1997, Congress authorized the FDA to gra ... Full text Link to item Cite

Criteria supporting the study of drugs in the newborn.

Journal Article Clin Ther · September 2006 BACKGROUND: Profound changes in the development and the maturation of neonates' organs and organ systems over variable periods of time potentially place neonates at increased risk and/or at different risks compared with adults or older children on exposure ... Full text Link to item Cite

Early, sustained efficacy of adeno-associated virus vector-mediated gene therapy in glycogen storage disease type Ia.

Journal Article Gene Ther · September 2006 The deficiency of glucose-6-phosphatase (G6Pase) underlies life-threatening hypoglycemia and growth retardation in glycogen storage disease type Ia (GSD-Ia). An adeno-associated virus (AAV) vector encoding G6Pase was pseudotyped as AAV8 and administered to ... Full text Link to item Cite

Orbital cellulitis in children.

Journal Article Pediatr Infect Dis J · August 2006 BACKGROUND: To review the epidemiology and management of orbital cellulitis in children. METHODS: The medical records of children < or = 18 years old and hospitalized from June 1, 1992, through May 31, 2002, at the Brenner Children's Hospital, with a disch ... Full text Link to item Cite

The association of third-generation cephalosporin use and invasive candidiasis in extremely low birth-weight infants.

Journal Article Pediatrics · August 2006 Featured Publication OBJECTIVES: Previous studies have shown that incidence of invasive candidiasis varies substantially among centers, and previous use of broad-spectrum antibiotics is a risk factor for candidiasis in extremely low birth-weight infants. Differences in center ... Full text Link to item Cite

Anidulafungin: a new echinocandin for the treatment of fungal infections.

Journal Article Drugs Today (Barc) · August 2006 Immunocompromised hosts are at increased risk for invasive fungal infections. Over the last five decades, the mainstay of therapy against systemic mycoses has revolved around amphotericin B deoxycholate. Unfortunately, this drug has substantial toxicities, ... Full text Link to item Cite

Racial differences are seen in blood pressure response to fosinopril in hypertensive children.

Journal Article Am Heart J · August 2006 BACKGROUND: Few antihypertensive therapies have been systematically studied in children and dosages for many agents are either extrapolated from adult studies or obtained from small homogenous pediatric populations. It is well established that adult patien ... Full text Link to item Cite

Increased case-fatality rate associated with outbreaks of Neisseria meningitidis infection, compared with sporadic meningococcal disease, in the United States, 1994-2002.

Journal Article Clin Infect Dis · July 1, 2006 BACKGROUND: Outbreaks of meningococcal disease are infrequent but important public health events. We characterize outbreak-associated cases in the United States and compare them with sporadic disease. METHODS: Outbreaks of meningococcal disease that occurr ... Full text Link to item Cite

Calcineurin controls growth, morphology, and pathogenicity in Aspergillus fumigatus.

Journal Article Eukaryot Cell · July 2006 Calcineurin is implicated in a myriad of human diseases as well as homeostasis and virulence in several major human pathogenic microorganisms. The fungus Aspergillus fumigatus is a leading cause of infectious death in the rapidly expanding immunocompromise ... Full text Link to item Cite

A blinded, randomized, multicenter study of an intravenous Staphylococcus aureus immune globulin.

Journal Article J Perinatol · May 2006 Featured Publication OBJECTIVES: Very low birth weight (VLBW) infants are vulnerable to nosocomial infections and subsequent morbidity; including infections caused by Staphylococcus aureus: 85% of nosocomial S. aureus infections are caused by capsular polysaccharide (CPS) type ... Full text Link to item Cite

Neonatal meningitis: what is the correlation among cerebrospinal fluid cultures, blood cultures, and cerebrospinal fluid parameters?

Journal Article Pediatrics · April 2006 Featured Publication BACKGROUND: Meningitis is a substantial cause of morbidity and mortality in neonates. Clinicians frequently use the presence of positive blood cultures to determine whether neonates should undergo lumbar puncture. Abnormal cerebrospinal fluid (CSF) paramet ... Full text Link to item Cite

Safety and pharmacokinetics of intravenous anidulafungin in children with neutropenia at high risk for invasive fungal infections.

Journal Article Antimicrob Agents Chemother · February 2006 Featured Publication Anidulafungin is an echinocandin with activity against Candida species and Aspergillus species. Adult dosages under study are 50 mg/day for esophageal candidiasis and 100 mg/day for invasive candidiasis and aspergillosis. Little is known, however, about th ... Full text Link to item Cite

A comparison of neonatal Gram-negative rod and Gram-positive cocci meningitis.

Journal Article J Perinatol · February 2006 OBJECTIVE: Neonatal meningitis is an illness with potentially devastating consequences. Early identification of potential risk factors for Gram-negative rod (GNR) infections versus Gram-positive cocci (GPC) infection prior to obtaining final culture result ... Full text Link to item Cite

Neonatal candidiasis among extremely low birth weight infants: risk factors, mortality rates, and neurodevelopmental outcomes at 18 to 22 months.

Journal Article Pediatrics · January 2006 Featured Publication BACKGROUND: Neonatal candidiasis is associated with substantial morbidity and mortality rates. Neurodevelopmental follow-up data for a large multicenter cohort have not been reported. METHODS: Data were collected prospectively for neonates born at <1000 g ... Full text Link to item Cite

National trends in health care utilization and racial and socioeconomic disparities in pediatric pyogenic arthritis.

Journal Article J Pediatr Orthop · 2006 PURPOSE: To determine national trends and putative racial and socioeconomic disparities in health care utilization in pediatric patients with pyogenic arthritis over a 13-year period. STUDY DESIGN: We assessed trends in length of hospital stay, hospital di ... Full text Link to item Cite

Critical appraisal of the role of Ureaplasma in the development of bronchopulmonary dysplasia with metaanalytic techniques.

Journal Article Pediatr Infect Dis J · December 2005 BACKGROUND: Controversy exists over whether or not Ureaplasma colonization or infection of the respiratory tract contributes to the development of bronchopulmonary dysplasia (BPD). Because BPD is a major cause of morbidity and mortality in preterm infants ... Full text Link to item Cite

New antifungal agents under development in children and neonates.

Journal Article Curr Opin Infect Dis · December 2005 PURPOSE OF REVIEW: This review focuses on only the newest antifungal agents recently approved or still under development and the available data in pediatric and neonatal patients. The larger body of data in adult patients is used for comparative purposes o ... Full text Link to item Cite

A meta-analysis of medical versus surgical therapy for Candida endocarditis.

Journal Article J Infect · October 2005 OBJECTIVES: The optimal management of Candida infective endocarditis (IE) is unknown. METHODS: We reviewed all 879 cases of Candida IE reported from 1966-2002 in the peer-reviewed literature to better understand the role of medical and surgical therapies. ... Full text Link to item Cite

Neonatal candidiasis.

Journal Article Infect Dis Clin North Am · September 2005 In neonates born weighing less than 750 g, invasive candidates is common and often fatal. This situation provides an opportunity to study antifungal prophylaxis and treatment in this patient population, in which the pharmacokinetics, safety, and efficacy o ... Full text Link to item Cite

Antifungal treatment in pediatric patients.

Journal Article Drug Resist Updat · August 2005 Invasive fungal infections have increased in frequency and severity over the past two decades as a result of an increasing number of immunocompromised patients. This new age of opportunistic fungal infections extends to pediatric patients. The last decade ... Full text Link to item Cite

Neonatal candidiasis: prophylaxis and treatment.

Journal Article Expert Opin Pharmacother · August 2005 The incidence of candidiasis has risen in neonatal intensive care units as advances in medical therapy have allowed for increased survival of extremely preterm neonates. The mortality of candidiasis has been reported to be 20% by several multi-centre studi ... Full text Link to item Cite

Cryptococcus neoformans {alpha} strains preferentially disseminate to the central nervous system during coinfection.

Journal Article Infect Immun · August 2005 Cryptococcus neoformans is a fungal pathogen that has evolved over the past 40 million years into three distinct varieties or sibling species (gattii, grubii, and neoformans). Each variety manifests differences in epidemiology and disease, and var. grubii ... Full text Link to item Cite

Invasive Candida infections in the neonate.

Journal Article Drug Resist Updat · June 2005 Advances in medical therapy have increased premature infant survival. A rise in Candida infections in neonatal intensive care units (NICUs) has followed. Once considered a contaminant, Candida is now recognized as a major cause of mortality and morbidity w ... Full text Link to item Cite

Improved neurodevelopmental outcomes following long-term high-dose oral acyclovir therapy in infants with central nervous system and disseminated herpes simplex disease.

Journal Article J Perinatol · March 2005 Featured Publication OBJECTIVE: Infants with neonatal herpes, classified as central nervous system or disseminated disease, have a high incidence of moderate and severe neurologic deficits despite standard acute therapy. STUDY DESIGN: Following completion of parenteral therapy ... Full text Link to item Cite

Risk factors for hematogenous complications of intravascular catheter-associated Staphylococcus aureus bacteremia.

Journal Article Clin Infect Dis · March 1, 2005 BACKGROUND: The role of both host and pathogen characteristics in hematogenous seeding following Staphylococcus aureus bacteremia is incompletely understood. METHODS: Consecutive patients with intravascular catheter-associated Staphylococcus aureus bactere ... Full text Link to item Cite

Risk of endocarditis among patients with prosthetic valves and Staphylococcus aureus bacteremia.

Journal Article Am J Med · March 2005 PURPOSE: Staphylococcus aureus is a common cause of bacteremia and of native valve infective endocarditis. However, the risk of endocarditis in patients with a prosthetic valve who develop S. aureus bacteremia is unclear. The aim of this study was to defin ... Full text Link to item Cite

In vitro interactions between antifungals and immunosuppressants against Aspergillus fumigatus isolates from transplant and nontransplant patients.

Journal Article Antimicrob Agents Chemother · December 2004 We performed in vitro antifungal checkerboard testing on 12 Aspergillus fumigatus clinical isolates (6 transplant recipients and 6 nontransplant patients) with three antifungal agents (amphotericin B, voriconazole, and caspofungin) and three immunosuppress ... Full text Link to item Cite

Growth as a part of the composite endpoint in paediatric antiretroviral clinical trials.

Journal Article J Antimicrob Chemother · October 2004 Paediatric HIV is a rapidly emerging disease in many resource-poor countries. Survival into adulthood is possible for HIV-infected children provided that they receive effective antiretroviral therapy (ART). Large trials comparing multiple regimens of ART i ... Full text Link to item Cite

Value of an inhalational model of invasive aspergillosis.

Journal Article Med Mycol · October 2004 Animal models of invasive aspergillosis have been used for virulence studies and antifungal efficacy evaluations but results have been inconsistent. In an attempt to reproduce human infection, many Aspergillus animal models have utilized a 'pulmonary route ... Full text Link to item Cite

Disseminated Candida tropicalis in a patient with chronic mucocutaneous candidiasis.

Journal Article South Med J · August 2004 Chronic mucocutaneous candidiasis is a heterogeneous group of immunodeficiencies associated with persistent candidal infections. Patients with chronic mucocutaneous candidiasis are rarely associated with systemic infections caused by other fungi, but almos ... Full text Link to item Cite

Infections due to Aspergillus terreus: a multicenter retrospective analysis of 83 cases.

Journal Article Clin Infect Dis · July 15, 2004 Current in vitro and in vivo data indicate that invasive aspergillosis due to Aspergillus terreus is resistant to treatment with amphotericin B. Because little clinical data are available to guide therapy, we performed a retrospective cohort study of cases ... Full text Link to item Cite

Prevention and treatment of nosocomial sepsis in the NICU.

Journal Article J Perinatol · July 2004 Nosocomial sepsis is a serious problem for neonates who are admitted for intensive care. It is associated with an increase in mortality, morbidity, and prolonged length of hospital stay. Thus, both the human and fiscal costs of these infections are high. A ... Full text Link to item Cite

Nosocomial infection in the NICU: a medical complication or unavoidable problem?

Journal Article J Perinatol · June 2004 Nosocomial sepsis is a serious problem for neonates who are admitted for intensive care. As it is associated with increases in mortality, morbidity, and prolonged length of hospital stay, both the human and fiscal costs of these infections are high. Althou ... Full text Link to item Cite

Role of complement receptors 1 and 2 (CD35 and CD21), C3, C4, and C5 in survival by mice of Staphylococcus aureus bacteremia.

Journal Article J Lab Clin Med · June 2004 Complement-mediated opsonization and phagocytosis of encapsulated serotype 5 Staphylococcus aureus are essential to host defense. We describe the effects of complement depletion and deficiencies of C4, C5, and complement receptors 1 and 2 on mouse survival ... Full text Link to item Cite

Early predictors of in-hospital death in infective endocarditis.

Journal Article Circulation · April 13, 2004 BACKGROUND: Data on early determinants of outcome in infective endocarditis (IE) are limited. We evaluated the prognostic significance of early clinical characteristics in a large, prospective cohort of patients with IE. METHODS AND RESULTS: Two hundred si ... Full text Link to item Cite

Active or prior GB virus C infection does not protect against vertical transmission of HIV in coinfected women from Tanzania.

Journal Article Clin Infect Dis · March 15, 2004 To determine whether GB virus C (GBV-C) infection is associated with protection against vertical transmission of human immunodeficiency virus (HIV), we tested 186 HIV-positive pregnant women for GBV-C. Neither active nor prior GBV-C infection was associate ... Full text Link to item Cite

Mortality following blood culture in premature infants: increased with Gram-negative bacteremia and candidemia, but not Gram-positive bacteremia.

Journal Article J Perinatol · March 2004 Featured Publication OBJECTIVE: To describe survival following nosocomial bloodstream infections and quantify excess mortality associated with positive blood culture. STUDY DESIGN: Multicenter cohort study of premature infants. RESULTS: First blood culture was negative for 464 ... Full text Link to item Cite

Postconception age and other risk factors associated with mortality following Gram-negative rod bacteremia.

Journal Article J Perinatol · March 2004 Featured Publication BACKGROUND: Neonatal nosocomial Gram-negative rod bacteremia (GNR-b) is considered ominous. DESIGN: Multi-center cohort study of premature infants (N=6172) who had a blood culture after day of life 3 and whose birthweight was < or =1250 g. RESULTS: A total ... Full text Link to item Cite

In vitro and in vivo efficacies of the new triazole albaconazole against Cryptococcus neoformans.

Journal Article Antimicrob Agents Chemother · February 2004 The activity of albaconazole (UR-9825; J. Uriach & Cía. S.A., Barcelona, Spain) was compared to that of fluconazole against 12 isolates of Cryptococcus neoformans in vitro and against 1 isolate in vivo in a rabbit model of cryptococcal meningitis. Albacona ... Full text Link to item Cite

Comparative safety of amphotericin B lipid complex and amphotericin B deoxycholate as aerosolized antifungal prophylaxis in lung-transplant recipients.

Journal Article Transplantation · January 27, 2004 BACKGROUND: Aerosolized administrations of amphotericin B deoxycholate (AmBd) and amphotericin B lipid complex (ABLC) in lung transplant recipients were compared for safety and tolerability. The incidence of invasive fungal infections in patients receiving ... Full text Link to item Cite

Latent class analysis: an illustrative application for education in the assessment of resident otoscopic skills.

Journal Article Ambul Pediatr · 2004 BACKGROUND: There is no gold standard readily available in several components of the routine physical exam: one example is the otoscopic exam, where the gold standard is confirmation by tympanocentesis. Resident education does not typically include routine ... Full text Link to item Cite

Growth patterns reflect response to antiretroviral therapy in HIV-positive infants: potential utility in resource-poor settings.

Journal Article AIDS Patient Care STDS · January 2004 Laboratory monitoring of HIV-infected children is the current standard of care in the United States to guide the appropriate use of antiretroviral therapy (ART). Although ART is becoming a reality in some developing countries, laboratory monitoring of ART ... Full text Link to item Cite

Candida endocarditis: contemporary cases from the International Collaboration of Infectious Endocarditis Merged Database (ICE-mD).

Journal Article Scand J Infect Dis · 2004 Candida infective endocarditis (IE) is increasingly common, yet most reports have been single-center reviews. We evaluated 16 patients with Candida IE nested within a cohort of 2,022 patients with IE. Prosthetic valve IE was more common in patients with Ca ... Full text Link to item Cite

A comparison of height and weight velocity as a part of the composite endpoint in pediatric HIV.

Journal Article AIDS · November 7, 2003 BACKGROUND: HIV adversely affects growth in children. Pediatric AIDS Clinical Trial Group (PACTG) protocols often use weight velocity [changes in weight z-score for age (WAZ)] as a part of the composite endpoint for phase II and III clinical trials. Howeve ... Full text Link to item Cite

Candida bloodstream infection in neonates.

Journal Article Semin Perinatol · October 2003 Neonatal candidemia is poorly understood and is a leading cause of nosocomial infectious mortality in the nursery. Prevention of candidemia has been difficult, although a combined approach of antifungal prophylaxis and targeted empirical therapy may eventu ... Full text Link to item Cite

Infrequent diagnosis of primary human immunodeficiency virus infection: missed opportunities in acute care settings.

Journal Article Arch Intern Med · September 22, 2003 Although primary human immunodeficiency virus infection (PHI) is usually symptomatic and early management is likely important, the diagnosis is infrequently made. We examined a prospectively enrolled cohort of individuals diagnosed as having PHI in the sou ... Full text Link to item Cite

Neonatal candidemia and end-organ damage: a critical appraisal of the literature using meta-analytic techniques.

Journal Article Pediatrics · September 2003 OBJECTIVE: Neonatal candidemia is an increasing cause of infant morbidity and mortality. We evaluated the current medical literature in an effort to critique the literature and to document the reported prevalences of end-organ damage after neonatal candide ... Full text Link to item Cite

Empirical therapy for neonatal candidemia in very low birth weight infants.

Journal Article Pediatrics · September 2003 OBJECTIVE: Neonatal candidemia is often fatal. Empirical antifungal therapy is associated with improved survival in neonates and patients with fever and neutropenia. Although guidelines for empirical therapy exist for patients with fever and neutropenia, t ... Full text Link to item Cite

Rare disorders of metabolism with elevated butyryl- and isobutyryl-carnitine detected by tandem mass spectrometry newborn screening.

Journal Article Pediatr Res · August 2003 Tandem mass spectrometry was adopted for newborn screening by North Carolina in April 1999. Since then, three infants with short-chain acyl-CoA dehydrogenase (SCAD) and one with isobutyryl-CoA dehydrogenase deficiency were detected on the basis of elevated ... Full text Link to item Cite

Delivery of glucose-6-phosphatase in a canine model for glycogen storage disease, type Ia, with adeno-associated virus (AAV) vectors.

Journal Article Gene Ther · August 2002 Therapy in glycogen storage disease type Ia (GSD Ia), an inherited disorder of carbohydrate metabolism, relies on nutritional support that postpones but fails to prevent long-term complications of GSD Ia. In the canine model for GSD Ia, we evaluated the po ... Full text Link to item Cite

Facial cellulitis in childhood: a changing spectrum.

Journal Article South Med J · July 2002 BACKGROUND: Before conjugated Haemophilus influenzae type b (Hib) vaccination, a syndrome known as buccal cellulitis, usually caused by Hib and often accompanied by bacteremia, was seen. We investigated the incidence and cause of facial cellulitis at our h ... Link to item Cite

Pediatric residents' clinical diagnostic accuracy of otitis media.

Journal Article Pediatrics · June 2002 OBJECTIVE: Pediatric resident physicians' clinical diagnostic accuracy of otitis media is unknown. We attempted to correlate the clinical examination of pediatric house staff with pediatric otolaryngologists and tympanometry. METHODS: Pediatric residents e ... Full text Link to item Cite

Thirty-day postoperative death rate at an academic medical center.

Journal Article Ann Surg · May 2002 OBJECTIVE: To improve understanding of perioperative deaths at an academic medical center. SUMMARY BACKGROUND DATA: Because published data have typically focused on specific patient populations, diagnoses, or procedures, there are few data regarding surgic ... Full text Link to item Cite

Integration of statistical theory and practical clinical expertise. Polymerase chain reaction testing of the HIV-exposed infant.

Journal Article Minerva Pediatr · April 2002 Testing of the human immunodeficiency virus (HIV)-exposed infant has improved markedly over the past decade. Polymerase chain reaction (PCR) technology has made accurate diagnosis possible by 4 months of age and improved sensitivity and specificity of PCR ... Link to item Cite

Infections diagnosed in the first year after pediatric stem cell transplantation.

Journal Article Pediatr Infect Dis J · March 2002 BACKGROUND: Cumulative incidence of infections in the first year posttransplantation in adult patients has been well-described. Such description is less than complete for pediatric stem cell transplantation (SCT) patients. Further among those patients who ... Full text Link to item Cite

Rational testing of the HIV-exposed infant.

Journal Article Pediatrics · July 2001 OBJECTIVES: The objectives of this study were 1) to evaluate testing regimens of human immunodeficiency virus (HIV)-exposed infants and 2) to determine optimal methods of follow-up by enzyme-linked immunosorbent assay (ELISA) testing. METHODS: We reviewed ... Full text Link to item Cite

Bacteremia, central catheters, and neonates: when to pull the line.

Journal Article Pediatrics · June 2001 OBJECTIVES: Physicians who treat neonates who become bacteremic while dependent on central venous catheters face a serious and common dilemma. We sought 1) to evaluate the relationship between central venous catheter removal and outcome in bacteremic neona ... Full text Link to item Cite

When to suspect fungal infection in neonates: A clinical comparison of Candida albicans and Candida parapsilosis fungemia with coagulase-negative staphylococcal bacteremia.

Journal Article Pediatrics · October 2000 OBJECTIVES: To determine the epidemiology of candidemia in our neonatal intensive care unit; to compare risk factors, clinical presentation, and outcomes for neonates infected with Candida albicans, Candida parapsilosis, and coagulase-negative staphylococc ... Full text Link to item Cite

Candidal mycetoma in the neonatal kidney.

Journal Article Pediatrics · November 1999 OBJECTIVE: To determine the natural history of renal mycetoma (fungal balls) in the neonate. DESIGN: Retrospective chart review of all neonatal intensive care unit patients with systemic candidiasis and sonographic evidence of renal mycetoma admitted to th ... Full text Link to item Cite