Scholars@Duke
Phillip Brian Smith

Phillip Brian Smith

Samuel L. Katz Distinguished Professor of Pediatrics
Pediatrics, Neonatology
Brian.Smith@duke.edu
DCRI, PO Box 17969, Durham, NC 27715
800 W. Morgan St Box 17969, DC 756, Durham, NC 27701

Selected Publications

Outcomes of Mothers and Infants Affected by COVID-19.

Journal Article Am J Perinatol · January 2026 The long-term effects of the novel coronavirus disease 2019 (COVID-19) infection during pregnancy are poorly characterized in mothers and their infants. The aim of this study was to assess the physical, mental, and emotional well-being of mothers and infan ... Full text Link to item Cite

A comparison of institutional review board models and study efficiency in the Environmental influences on Child Health Outcomes Cohort Consortium.

Journal Article Contemp Clin Trials · January 2026 BACKGROUND: Institutional review board (IRB) approval is a key step in site activation and study initiation. Single IRBs aim to improve the timeliness of IRB review through centralization and standardization, whereas local IRBs conduct reviews only for spe ... Full text Link to item Cite

Early Effective Antibiotic Therapy and Meningitis following a Bloodstream Infection in Hospitalized Infants: A Cohort Study.

Journal Article Am J Perinatol · December 2025 This study aimed to evaluate the role of early effective antibiotic therapy in preventing secondary meningitis as a sequelae of bacterial bloodstream infections (BSI).In this multicenter cohort study, we identified blood cultures that were positive for Gro ... Full text Link to item Cite

Infantile-onset Pompe disease entering adulthood: Insights from 2 decades of enzyme replacement therapy experience.

Journal Article Genet Med · December 2025 PURPOSE: This study details the long-term clinical outcomes in adult participants with CRIM-positive infantile-onset Pompe disease treated with enzyme replacement therapy (ERT), initially reported in 2012 (n = 11). METHODS: Medical records were reviewed fo ... Full text Link to item Cite

Infliximab Pharmacokinetics, Dosing, and Response in Hospitalized Patients with COVID-19 Pneumonia: A Secondary Analysis of a Multinational Randomized Clinical Trial (ACTIV-1 IM).

Journal Article J Clin Pharmacol · November 2025 Infliximab may play an important role in reducing mortality in severe COVID-19, though optimal dosing is unknown. This secondary analysis of the ACTIV-1 IM trial characterized infliximab pharmacokinetics and outcomes in patients hospitalized with severe CO ... Full text Link to item Cite

Antenatal Exposure to Medication for Opioid Use Disorder and Infant Outcomes in the Eat, Sleep, Console for Neonatal Opioid Withdrawal Randomized Controlled Trial.

Journal Article J Pediatr · October 17, 2025 OBJECTIVE: To evaluate associations between care approach (usual care vs Eat, Sleep, Console [ESC]) on infant outcomes, and how these associations were modified by medication (buprenorphine or methadone) for opioid use disorder (MOUD). STUDY DESIGN: A post ... Full text Link to item Cite

Cerebrospinal Fluid Composition of Infants with Ischemic Stroke.

Journal Article Am J Perinatol · August 2025 This study aimed to characterize the cerebrospinal fluid (CSF) of infants with stroke and compare those findings to the CSF of infants with bacterial meningitis and neither condition in the first 14 postnatal days.Cohort study of 30,092 infants who receive ... Full text Link to item Cite

Association Between Prenatal Antibiotic Exposure and Infant Wheeze Outcomes.

Journal Article Acta Paediatr · August 2025 AIM: This study examined the association between antibiotic exposure during pregnancy and the development of wheezing and cough during infancy. METHODS: We analysed data from 12 cohorts in the Environmental influences on Child Health Outcomes Cohort Consor ... Full text Link to item Cite

Furosemide Safety in Preterm Infants at Risk for Bronchopulmonary Dysplasia: A Randomized Clinical Trial.

Journal Article J Pediatr · August 2025 OBJECTIVE: To evaluate the safety of furosemide in preterm infants at the risk of developing bronchopulmonary dysplasia (BPD). STUDY DESIGN: This multicenter, randomized, dose-escalating, placebo-controlled trial enrolled infants born <29 weeks gestational ... Full text Link to item Cite

A Systematic Review of Race or Ethnicity and Risk of Death in Spina Bifida in the United States.

Journal Article J Child Neurol · August 2025 ObjectiveWe performed a systematic review of studies of mortality risk in spina bifida by race or ethnicity to determine if risks were relatively greater in Black or in Hispanic people with spina bifida than in White people in most studies.MethodsWe includ ... Full text Link to item Cite

Maternal Area of Residence and Outcomes for Mother-Infant Dyads with Perinatal Opioid Exposure.

Journal Article Am J Perinatol · June 16, 2025 Determine the relationship between maternal Social Deprivation Index (SDI), a composite measure of area-level deprivation, and maternal characteristics and infant outcomes for mother-infant dyads with perinatal opioid exposure.Post hoc secondary analysis o ... Full text Link to item Cite

Prediction of internalizing and externalizing symptoms in late childhood from attention-deficit/hyperactivity disorder symptoms in early childhood.

Journal Article Dev Psychopathol · May 2025 Limited analyses based on national samples have assessed whether early attention-deficit/hyperactivity disorder (ADHD) symptoms predict later internalizing and externalizing symptoms in youth and the influence of sex and pubertal timing on subsequent psych ... Full text Link to item Cite

Association between maternal stress and child sleep quality: a nationwide ECHO prospective cohort study.

Journal Article Pediatr Res · February 2025 BACKGROUND: Childhood sleep quality is associated with physical, cognitive, and behavioral health and predicts later sleep quality; it has many determinants, including developmental exposures. OBJECTIVES: To examine associations between maternal stress dur ... Full text Link to item Cite

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

Journal Article J Perinatol · January 2025 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

SARS-CoV-2 N protein and anti-spike serologies: insights into COVID-19 disease severity and mortality-a secondary analysis of the ACTIV-1 trial.

Journal Article Ther Adv Infect Dis · 2025 BACKGROUND: Understanding factors that predict progression to severe COVID-19 is critical. Antibodies targeting SARS-CoV-2 spike protein confer protection, while the N protein of SARS-CoV-2 plays roles in viral replication and immune dysfunction. This stud ... Full text Link to item Cite

Infant Feeding and Weight Trajectories in the Eat, Sleep, Console Trial: A Secondary Analysis of a Randomized Clinical Trial.

Journal Article JAMA Pediatr · October 1, 2024 IMPORTANCE: Infants with neonatal opioid withdrawal syndrome (NOWS) cared for with the Eat, Sleep, Console (ESC) care approach receive less pharmacologic treatment and have shorter hospital stays compared to usual care with the Finnegan Neonatal Abstinence ... Full text Link to item Cite

Association of maternal fish consumption and ω-3 supplement use during pregnancy with child autism-related outcomes: results from a cohort consortium analysis.

Journal Article Am J Clin Nutr · September 2024 BACKGROUND: Prenatal fish intake is a key source of omega-3 (ω-3) polyunsaturated fatty acids needed for brain development, yet intake is generally low, and studies addressing associations with autism spectrum disorder (ASD) and related traits are lacking. ... Full text Link to item Cite

Developmental characteristics and accuracy of autism screening among two-year-old toddlers in the ECHO program.

Journal Article Pediatr Res · September 2024 BACKGROUND: The Modified Checklist for Autism in Toddlers (M-CHAT) is a common pediatric screening tool with mixed accuracy findings. Prior evidence supports M-CHAT screening for developmental concerns, especially in toddlers born preterm. This study exami ... Full text Link to item Cite

Association of Growth During Infancy with Neurodevelopment and Obesity in Children Born Very Preterm: The Environmental Influences on Child Health Outcomes Cohort.

Journal Article J Pediatr · August 2024 OBJECTIVE: To evaluate associations between change in weight z score after neonatal intensive care unit (NICU) discharge and neurodevelopmental outcomes and obesity at 12-48 months of age among individuals born very preterm. STUDY DESIGN: This secondary an ... Full text Link to item Cite

Examining the association between prenatal cannabis exposure and child autism traits: A multi-cohort investigation in the environmental influences on child health outcome program

Journal Article Autism Research · August 1, 2024 This study examined the association between prenatal cannabis exposure and autism spectrum disorder (ASD) diagnoses and traits. A total sample of 11,570 children (ages 1–18; 53% male; 25% Hispanic; 60% White) from 34 cohorts of the National Institutes of H ... Full text Cite

Epigenetic associations in HPA axis genes related to bronchopulmonary dysplasia and antenatal steroids.

Journal Article Pediatr Res · July 2024 BACKGROUND: Bronchopulmonary dysplasia (BPD), a common morbidity among very preterm infants, is associated with chronic disease and neurodevelopmental impairments. A hypothesized mechanism for these outcomes lies in altered glucocorticoid (GC) activity. We ... Full text Link to item Cite

Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial.

Journal Article JAMA Pediatr · June 1, 2024 IMPORTANCE: The function-based eat, sleep, console (ESC) care approach substantially reduces the proportion of infants who receive pharmacologic treatment for neonatal opioid withdrawal syndrome (NOWS). This reduction has led to concerns for increased post ... Full text Link to item Cite

Approaches to protocol standardization and data harmonization in the ECHO-wide cohort study.

Journal Article Pediatr Res · June 2024 The United States (U.S.) National Institutes of Health-funded Environmental influences on Child Health Outcomes (ECHO)-wide Cohort was established to conduct high impact, transdisciplinary science to improve child health and development. The cohort is a co ... Full text Link to item Cite

Reproducibility between preschool and school-age Social Responsiveness Scale forms in the Environmental influences on Child Health Outcomes program.

Journal Article Autism Res · June 2024 Evidence suggests core autism trait consistency in older children, but development of these traits is variable in early childhood. The Social Responsiveness Scale (SRS) measures autism-related traits and broader autism phenotype, with two age-dependent for ... Full text Link to item Cite

Host factors are associated with vaginal microbiome structure in pregnancy in the ECHO Cohort Consortium.

Journal Article Sci Rep · May 23, 2024 Using pooled vaginal microbiota data from pregnancy cohorts (N = 683 participants) in the Environmental influences on Child Health Outcomes (ECHO) Program, we analyzed 16S rRNA gene amplicon sequences to identify clinical and demographic host factors that ... Full text Link to item Cite

Insulin for Treatment of Neonatal Hyperglycemia in Premature Infants: Prevalence over Time and Association with Outcomes.

Journal Article Am J Perinatol · May 2024 OBJECTIVE: Our objective was to determine the prevalence of insulin treatment in premature infants with hyperglycemia and evaluate the association of length of treatment with outcomes. STUDY DESIGN: The study included cohort of 29,974 infants 22 to 32 week ... Full text Link to item Cite

Prenatal Substance Exposure: Associations with Neurodevelopment in Middle Childhood.

Journal Article Am J Perinatol · May 2024 OBJECTIVE: Single-substance exposure effects on neurodevelopmental outcomes, such as problem behavior and intelligence quotient (IQ), have been studied in children for decades. However, the long-term consequences of polysubstance exposure are poorly unders ... Full text Open Access Link to item Cite

Perinatal Outcomes during versus Prior to the COVID-19 Pandemic and the Role of Maternal Depression and Perceived Stress: A Report from the ECHO Program.

Journal Article Am J Perinatol · May 2024 OBJECTIVE: We sought to evaluate the impact of the coronavirus disease 2019 (COVID-19) pandemic on perinatal outcomes while accounting for maternal depression or perceived stress and to describe COVID-specific stressors, including changes in prenatal care, ... Full text Link to item Cite

COVID-19 Stress and Child Behavior: Examining Discrimination and Social Support in Racially Diverse ECHO Cohorts.

Journal Article J Am Acad Child Adolesc Psychiatry · May 2024 OBJECTIVE: To examine the additive or moderating influences of caregiver COVID-19-related stress, social support, and discrimination on children's behavior problems across racially diverse populations. METHOD: In this Environmental influences on Child Heal ... Full text Link to item Cite

Birth outcomes in relation to neighborhood food access and individual food insecurity during pregnancy in the Environmental Influences on Child Health Outcomes (ECHO)-wide cohort study.

Journal Article Am J Clin Nutr · May 2024 BACKGROUND: Limited access to healthy foods, resulting from residence in neighborhoods with low-food access or from household food insecurity, is a public health concern. Contributions of these measures during pregnancy to birth outcomes remain understudie ... 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

Prenatal phthalate exposure and adverse birth outcomes in the USA: a prospective analysis of births and estimates of attributable burden and costs.

Journal Article Lancet Planet Health · February 2024 BACKGROUND: Phthalates are synthetic chemicals widely used in consumer products and have been identified to contribute to preterm birth. Existing studies have methodological limitations and potential effects of di-2-ethylhexyl phthalate (DEHP) replacements ... Full text Link to item Cite

The Hassan Neonatal Morbidity Composite Scale and Neonatal Length of Stay-A Validation Study.

Journal Article Am J Perinatol · January 2024 OBJECTIVE: Obstetric studies often report neonatal morbidity as a composite score. Composite scores can simplify data analysis when multiple outcomes of interest are present and allows researchers to conduct smaller, more manageable trials. The Hassan scal ... 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

Underimmunization of very low birth weight infants at discharge from the neonatal intensive care unit.

Journal Article J Perinatol · January 2024 OBJECTIVE: To quantify immunization status among premature infants discharged from neonatal intensive care units (NICUs), and identify risk factors for underimmunization. STUDY DESIGN: We performed a cohort study of infants <33 weeks gestation discharged h ... Full text Link to item Cite

Using ECHO program data to develop a brief measure of caregiver support and cognitive stimulation using the home observation for measurement of the environment-infant/toddler (HOME-IT).

Journal Article Child Dev · 2024 Data from three NIH Environmental influences on Child Health Outcomes (ECHO) Program cohorts that collected the HOME-Infant-Toddler (HOME-IT age 0-3 years) version were used to examine the reliability of a brief scale of caregiver support and cognitive sti ... Full text Link to item Cite

Maternal stress and early childhood BMI among US children from the Environmental influences on Child Health Outcomes (ECHO) program.

Journal Article Pediatr Res · December 2023 BACKGROUND: We aimed to understand the association between maternal stress in the first year of life and childhood body mass index (BMI) from 2 to 4 years of age in a large, prospective United States-based consortium of cohorts. METHODS: We used data from ... Full text Link to item Cite

Evaluation of pediatric epigenetic clocks across multiple tissues.

Journal Article Clin Epigenetics · September 2, 2023 BACKGROUND: Epigenetic clocks are promising tools for assessing biological age. We assessed the accuracy of pediatric epigenetic clocks in gestational and chronological age determination. RESULTS: Our study used data from seven tissue types on three DNA me ... Full text Link to item Cite

Latent Class Analysis of Prenatal Substance Exposure and Child Behavioral Outcomes.

Journal Article J Pediatr · September 2023 OBJECTIVES: To predict behavioral disruptions in middle childhood, we identified latent classes of prenatal substance use. STUDY DESIGN: As part of the Environmental influences on Child Health Outcomes Program, we harmonized prenatal substance use data and ... Full text Open Access Link to item Cite

An exploratory study of plasma ceramides in comorbidities in Down syndrome.

Journal Article Am J Med Genet A · September 2023 Plasma ceramide levels (henceforth, "ceramides") are biomarkers of some diseases that are comorbidities of Down syndrome (DS). We sought to determine if comorbidities in DS were associated with ceramides, studying a convenience cohort of 35 study participa ... Full text Link to item Cite

20-αHydroxycholesterol, an oxysterol in human breast milk, reverses mouse neonatal white matter injury through Gli-dependent oligodendrogenesis.

Journal Article Cell Stem Cell · August 3, 2023 White matter injuries (WMIs) are the leading cause of neurologic impairment in infants born premature. There are no treatment options available. The most common forms of WMIs in infants occur prior to the onset of normal myelination, making its pathophysio ... Full text Open Access 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

Eat, Sleep, Console Approach or Usual Care for Neonatal Opioid Withdrawal.

Journal Article N Engl J Med · June 22, 2023 BACKGROUND: Although clinicians have traditionally used the Finnegan Neonatal Abstinence Scoring Tool to assess the severity of neonatal opioid withdrawal, a newer function-based approach - the Eat, Sleep, Console care approach - is increasing in use. Whet ... Full text Link to item Cite

The Influence of Mediators on the Relationship Between Antenatal Opioid Agonist Exposure and the Severity of Neonatal Opioid Withdrawal Syndrome.

Journal Article Matern Child Health J · June 2023 OBJECTIVES: (1) To evaluate the direct (un-mediated) and indirect (mediated) relationship between antenatal exposure to opioid agonist medication as treatment for opioid use disorder (MOUD) and the severity of neonatal opioid withdrawal syndrome (NOWS), an ... 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

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

Associations of SARS-CoV-2 antibodies with birth outcomes: Results from three urban birth cohorts in the NIH environmental influences on child health outcomes program.

Journal Article PLoS One · 2023 Studies suggest perinatal infection with SARS-CoV-2 can induce adverse birth outcomes, but studies published to date have substantial limitations. We therefore conducted an observational study of 211 births occurring between January 2020-September 2021 in ... Full text Link to item Cite

Immunophenotype associated with high sustained antibody titers against enzyme replacement therapy in infantile-onset Pompe disease.

Journal Article Front Immunol · 2023 INTRODUCTION: The efficacy of enzyme replacement therapy (ERT) with alglucosidase alfa for infantile-onset Pompe disease (IOPD) is limited in some patients due to the development of high and sustained antibody titers (HSAT; ≥12,800). METHODS: We carried ou ... 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

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

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

Association between postmenstrual age and furosemide dosing practices in very preterm infants.

Journal Article J Perinatol · April 2022 OBJECTIVE: Furosemide renal clearance is slow after very preterm (VP) birth and increases with postnatal maturation. We compared furosemide dose frequency and total daily dose between postmenstrual age (PMA) groups in VP infants. STUDY DESIGN: Observationa ... Full text 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

Safety of sildenafil in extremely premature infants: a phase I trial.

Journal Article J Perinatol · January 2022 OBJECTIVE: To characterize the safety of sildenafil in premature infants. STUDY DESIGN: A phase I, open-label trial of sildenafil in premature infants receiving sildenafil per usual clinical care (cohort 1) or receiving a single IV dose of sildenafil (coho ... Full text Link to item Cite

Invasive fungal infections in neonates: a review.

Journal Article Pediatr Res · January 2022 Invasive fungal infections remain the leading causes of morbidity and mortality in neonates, especially preterm and very low birth weight infants. Most invasive fungal infections are due to Candida or Aspergillus species, and other fungi are increasingly r ... 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

Stannsoporfin with phototherapy to treat hyperbilirubinemia in newborn hemolytic disease.

Journal Article J Perinatol · January 2022 OBJECTIVE: To evaluate the efficacy and safety of tin mesoporphyrin (SnMP) in neonates with hyperbilirubinemia (HB) due to hemolysis. STUDY DESIGN: This multicenter, placebo-controlled phase 2b study (NCT01887327) randomized newborns (35-42 weeks) with hem ... Full text Link to item Cite

A retrospective longitudinal study and comprehensive review of adult patients with glycogen storage disease type III.

Journal Article Mol Genet Metab Rep · December 2021 INTRODUCTION: A deficiency of glycogen debrancher enzyme in patients with glycogen storage disease type III (GSD III) manifests with hepatic, cardiac, and muscle involvement in the most common subtype (type a), or with only hepatic involvement in patients ... Full text Open Access Link to item Cite

Vasoactive medications in extremely low gestational age neonates during the first postnatal week.

Journal Article J Perinatol · September 2021 OBJECTIVE: The management of early hypotension in extremely low gestational age neonates (ELGANs) varies greatly between centers. The objective of this study was to provide updated data on the use of vasoactive medications in ELGANs during the first postna ... 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 J Autism Dev Disord · 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 Link to item 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

Medicine in a forgotten corner of Africa: how EMR can benefit the developing world - The FIMRC and EMR4DW experience.

Journal Article Eur Rev Med Pharmacol Sci · June 2021 OBJECTIVE: The aim of this study is to analyze the disease prevalence of a rural African village and discuss how to maximize the outcomes of health projects. The analysis was based on electronic medical records (EMR) at a clinic in Bududa, Uganda. The inst ... Full text Link to item Cite

Cognitive and motor function in adults with spina bifida myelomeningocele: a pilot study.

Journal Article Childs Nerv Syst · April 2021 PURPOSE: Determine the feasibility and utility of using a battery of tests utilized, so far, to assess neurological-cognitive functions in the typical adult population and identify the spectrum of these functions in adult SBM patients. METHODS: Prospective ... Full text Link to item Cite

Association between Hyperbilirubinemia and Hearing Screen Failure in the Neonatal Intensive Care Unit in Infants Born Preterm.

Journal Article J Pediatr · April 2021 OBJECTIVE: To characterize the association between hyperbilirubinemia and a failed newborn hearing screen in infants born at 22-32 weeks of gestation. STUDY DESIGN: We included infants with gestational ages of 22-32 weeks who were discharged from neonatal ... Full text Link to item Cite

Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome.

Journal Article Pediatrics · March 2021 BACKGROUND AND OBJECTIVES: Despite the neonatal opioid withdrawal syndrome (NOWS) epidemic in the United States, evidence is limited for pharmacologic management when first-line opioid medications fail to control symptoms. The objective with this study was ... 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

Site-Level Variation in the Characteristics and Care of Infants With Neonatal Opioid Withdrawal.

Journal Article Pediatrics · January 2021 BACKGROUND AND OBJECTIVES: Variation in pediatric medical care is common and contributes to differences in patient outcomes. Site-to-site variation in the characteristics and care of infants with neonatal opioid withdrawal syndrome (NOWS) has yet to be qua ... Full text Link to item Cite

Global research priorities on COVID-19 for maternal, newborn, child and adolescent health.

Journal Article J Glob Health · 2021 BACKGROUND: This research prioritization aimed to identify major research gaps in maternal, newborn, child and adolescent health (MNCAH) to help mitigate the direct and indirect effects of the COVID-19 pandemic. METHODS: We adapted the Child Health and Nut ... 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

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

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

Wide variation in caffeine discontinuation timing in premature infants.

Journal Article J Perinatol · February 2020 OBJECTIVE: To assess site variability and concomitant respiratory support related to the timing of caffeine discontinuation, and compare clinical characteristics of infants who discontinued caffeine before vs. within the last week of hospitalization. STUDY ... Full text Link to item Cite

Comparative safety profile of chloral hydrate versus other sedatives for procedural sedation in hospitalized infants.

Journal Article J Neonatal Perinatal Med · 2020 BACKGROUND: Given the limited available evidence on chloral hydrate safety in neonatal populations and the discrepancy in chloral hydrate acceptance between the US and other countries, we sought to clarify the safety profile of chloral hydrate compared to ... 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

Liver fibrosis during clinical ascertainment of glycogen storage disease type III: a need for improved and systematic monitoring.

Journal Article Genet Med · December 2019 PURPOSE: In glycogen storage disease type III (GSD III), liver aminotransferases tend to normalize with age giving an impression that hepatic manifestations improve with age. However, despite dietary treatment, long-term liver complications emerge. We pres ... 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

Patterns of phlebotomy blood loss and transfusions in extremely low birth weight infants.

Journal Article J Perinatol · December 2019 OBJECTIVE: Characterize frequency and volume of blood draws and transfusions in extremely low birth weight infants in the first 10 weeks of life. STUDY DESIGN: We included infants with a birth weight <1000 g born 23 0/7-29 6/7 weeks gestational age (GA) an ... Full text Link to item Cite

Dexmedetomidine Pharmacokinetics and a New Dosing Paradigm in Infants Supported With Cardiopulmonary Bypass.

Journal Article Anesth Analg · December 2019 BACKGROUND: Dexmedetomidine is increasingly used off-label in infants and children with cardiac disease during cardiopulmonary bypass (CPB) and in the postoperative period. Despite its frequent use, optimal dosing of dexmedetomidine in the setting of CPB h ... Full text Link to item Cite

Gastrostomy Tube Feeding in Extremely Low Birthweight Infants: Frequency, Associated Comorbidities, and Long-term Outcomes.

Journal Article J Pediatr · November 2019 OBJECTIVE: To assess the frequency of gastrostomy tube (GT) placement in extremely low birth weight (ELBW) infants, associated comorbidities, and long-term outcomes. STUDY DESIGN: Analysis of ELBW infants from 25 centers enrolled in the National Institute ... Full text Link to item Cite

Risk of development of treated retinopathy of prematurity in very low birth weight infants.

Journal Article J Perinatol · November 2019 OBJECTIVE: Quantify the risk of treatment for retinopathy of prematurity (ROP) among infants meeting current U.S. screening guidelines. STUDY DESIGN: Among infants ≤1500 g birth weight or ≤30 weeks gestation screened for ROP from 2006-2015, we developed a ... Full text Link to item Cite

Variation in Gastrostomy Tube Placement in Premature Infants in the United States.

Journal Article Am J Perinatol · October 2019 OBJECTIVE: To describe the variation in surgical gastrostomy tube (SGT) placement in premature infants among neonatal intensive care units (NICUs) in the United States. STUDY DESIGN: We identified 8,781 premature infants discharged from 114 NICUs in the Pe ... 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

Inadequate oral feeding as a barrier to discharge in moderately preterm infants.

Journal Article J Perinatol · September 2019 OBJECTIVES: The objectives describe the frequency that inadequate oral feeding (IOF) is the reason why moderately preterm (MPT) infants remain hospitalized and its association with neonatal morbidities. STUDY DESIGN: Prospective study using the NICHD Neona ... 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

Trial Characteristics That Affect Parental Consent in Neonatal Drug Trials.

Journal Article Am J Perinatol · June 2019 OBJECTIVE: The main purpose of this article is to determine parental consent rates in neonatal drug trials and describe trial characteristics associated with higher rates. STUDY DESIGN: We included neonatal drug trials published between 2009 and 2014 and c ... Full text Link to item Cite

Prolonged duration of early antibiotic therapy in extremely premature infants.

Journal Article Pediatr Res · June 2019 BACKGROUND: Prolonged early antibiotics in extremely premature infants may have negative effects. We aimed to assess prevalence and outcomes of provision of prolonged early antibiotics to extremely premature infants in the absence of culture-confirmed infe ... 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

Cognitive, adaptive, and behavioral profiles and management of alternating hemiplegia of childhood.

Journal Article Dev Med Child Neurol · May 2019 AIM: To determine the neuropsychological abnormalities that occur in alternating hemiplegia of childhood (AHC) and report on our experience in managing them. METHOD: Patients underwent evaluations according to our standardized AHC pathway. Data were entere ... Full text Link to item Cite

Surfactant Administration in Preterm Infants: Drug Development Opportunities.

Journal Article J Pediatr · May 2019 OBJECTIVE: To evaluate how frequently surfactant is used off-label in preterm infants. STUDY DESIGN: We conducted a retrospective cohort analysis of prospectively collected administrative data for 2005-2015 from 348 neonatal intensive care units in the US. ... 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

In reply

Journal Article Respiratory Care · April 1, 2019 Full text Cite

Evaluating Endotracheal Tube Depth in Infants Weighing Less Than 1 Kilogram.

Journal Article Respir Care · March 2019 BACKGROUND: Endotracheal tube (ETT) depth in premature infants is of critical importance because potentially life-threatening adverse events can occur if the tube is malpositioned. Analysis of current data indicates that the accuracy of current resuscitati ... 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

Sildenafil Exposure in the Neonatal Intensive Care Unit.

Journal Article Am J Perinatol · February 2019 OBJECTIVE: Pulmonary hypertension causes substantial morbidity and mortality in infants. Although Food and Drug Administration approved to treat pulmonary arterial hypertension in adults, sildenafil is not approved for infants. We sought to describe silden ... Full text Link to item Cite

Duration of Pediatric Clinical Trials Submitted to the US Food and Drug Administration.

Journal Article JAMA Pediatr · January 1, 2019 IMPORTANCE: The increasing prevalence of pediatric chronic disease has resulted in increased exposure to long-term drug therapy in children. The duration of recently completed drug trials that support approval for drug therapy in children with chronic dise ... Full text Link to item Cite

Intranasal midazolam and fentanyl for procedural sedation and analgesia in infants in the neonatal intensive care unit.

Journal Article J Neonatal Perinatal Med · 2019 BACKGROUND: The intranasal route is a minimally invasive method for rapidly delivering midazolam and fentanyl to provide short-term analgesia and sedation in infants. However, intranasal use of midazolam and fentanyl is not labeled for infants and safety d ... Full text Link to item Cite

Correction to: Association between furosemide in premature infants and sensorineural hearing loss and nephrocalcinosis: a systematic review.

Journal Article Matern Health Neonatol Perinatol · 2019 [This corrects the article DOI: 10.1186/s40748-018-0092-2.]. ... Full text Link to item Cite

National Survey of Neonatal Intensive Care Unit Medication Safety Practices.

Journal Article Am J Perinatol · December 2018 OBJECTIVE: We conducted a detailed survey to identify medication safety practices among a large network of United States neonatal intensive care units (NICUs). METHODS: We created a 53-question survey to assess 300 U.S. NICU's demographics, medication safe ... Full text Link to item Cite

Morphine vs Methadone Treatment for Infants with Neonatal Abstinence Syndrome.

Journal Article J Pediatr · December 2018 OBJECTIVE: To estimate the relationship of initial pharmacotherapy with methadone or morphine and length of stay (LOS) in infants with neonatal abstinence syndrome (NAS) admitted to the neonatal intensive care unit (NICU). STUDY DESIGN: From the Pediatrix ... Full text 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

Racial/ethnic differences in necrotizing enterocolitis incidence and outcomes in premature very low birth weight infants.

Journal Article J Perinatol · October 2018 BACKGROUND: As advances in neonatal intensive care increase the survival of extremely premature infants, the at-risk population for necrotizing enterocolitis (NEC) continues to rise. Although racial health disparities in preterm births have been well docum ... 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

Outcomes of preterm infants treated with hypothermia for hypoxic-ischemic encephalopathy.

Journal Article Early Hum Dev · October 2018 BACKGROUND: Therapeutic hypothermia reduces the risk of death, or moderate to severe neurodevelopmental impairment (NDI) in term infants with hypoxic-ischemic encephalopathy (HIE). Reports of its safety and efficacy in preterm infants are scarce. OBJECTIVE ... 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

Association between Furosemide Exposure and Patent Ductus Arteriosus in Hospitalized Infants of Very Low Birth Weight.

Journal Article J Pediatr · August 2018 OBJECTIVE: To evaluate the association between furosemide exposure and patent ductus arteriosus (PDA) in a large, contemporary cohort of hospitalized infants with very low birth weight (VLBW). STUDY DESIGN: Using the Pediatrix Medical Group Clinical Data W ... Full text Link to item Cite

Leveraging Big Data in Pediatric Development Programs: Proceedings From the 2016 American College of Clinical Pharmacology Annual Meeting Symposium.

Journal Article Clin Pharmacol Ther · July 2018 This article discusses the use of big data in pediatric drug development. The article covers key topics discussed at the ACCP annual meeting symposium in 2016 including the extent to which big data or real-world data can inform clinical trial design and su ... Full text Link to item Cite

Reply.

Journal Article J Pediatr · July 2018 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

A multi-institution analysis of predictors of timing of inguinal hernia repair among premature infants.

Journal Article J Pediatr Surg · April 2018 PURPOSE: Inguinal hernias are common in premature infants, but there is substantial variation with regards to timing of repair. We sought to quantify and explain this variation. METHODS: Cohort study of infants <34weeks gestation diagnosed with an inguinal ... 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

Use of a Midliner Positioning System for Prevention of Dolichocephaly in Preterm Infants.

Journal Article Pediatr Phys Ther · April 2018 PURPOSE: The purpose of this study was to determine effectiveness of a midliner positioning system (MPS, Tortle Midliner) for preventing dolichocephaly. METHODS: This was a nonrandomized, prospective study of 30 premature infants (study cohort, SC) using a ... 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

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

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

Epidemiology of preoperative hematologic assessment of children cared for in a pediatric emergency department.

Journal Article Am J Emerg Med · January 2018 OBJECTIVE: To assess frequency of preoperative hematologic testing in a tertiary care pediatric emergency department (PED) and how often these values predict clinical outcome or change management decisions. METHODS: Single-center retrospective cohort study ... Full text Link to item Cite

Association between oral sildenafil dosing, predicted exposure, and systemic hypotension in hospitalised infants.

Journal Article Cardiol Young · January 2018 BACKGROUND: The relationship between sildenafil dosing, exposure, and systemic hypotension in infants is incompletely understood. OBJECTIVES: The aim of this study was to characterise the relationship between predicted sildenafil exposure and hypotension i ... 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

Antenatal methadone vs buprenorphine exposure and length of hospital stay in infants admitted to the intensive care unit with neonatal abstinence syndrome.

Journal Article J Perinatol · January 2018 OBJECTIVE: Antenatal exposure to methadone or buprenorphine often causes neonatal abstinence syndrome (NAS) in newborns. However, comparative effects on affected infants' hospital courses are inconclusive. We sought to estimate the relationship of antenata ... Full text Link to item Cite

Candida Species

Chapter · January 1, 2018 Full text Cite

Association between furosemide in premature infants and sensorineural hearing loss and nephrocalcinosis: a systematic review.

Journal Article Matern Health Neonatol Perinatol · 2018 Furosemide is a potent loop diuretic commonly and variably used by neonatologists to improve oxygenation and lung compliance in premature infants. There are several safety concerns with use of furosemide in premature infants, specifically the risk of senso ... Full text Link to item 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

An anthropometric survey of US pre-term and full-term neonates.

Journal Article Ann Hum Biol · December 2017 BACKGROUND: Anthropometric data prove valuable for screening and monitoring various medical conditions. In young infants, however, only weight, length and head circumference are represented in publicly accessible databases. AIM: To characterise length and ... Full text Link to item Cite

Antifungal Drugs in Newborns and Children.

Journal Article Pediatr Clin North Am · December 2017 Invasive fungal infections are a significant cause of morbidity and mortality in infants and children. Early diagnosis is critical, and treatment with the appropriate drug and dose should be initiated promptly. Although an increasing number of studies have ... Full text Link to item Cite

In-Hospital Outcomes Following Extracorporeal Membrane Oxygenation in a Retrospective Cohort of Infants.

Journal Article Am J Perinatol · November 2017 OBJECTIVE: We sought to characterize associations between infant characteristics and extracorporeal membrane oxygenation (ECMO) survival using electronic health records data. STUDY DESIGN: We examined a cohort study of infants ≥32 weeks of gestational age ... Full text Link to item Cite

Association between early echocardiography, therapy for patent ductus arteriosus, and outcomes in very low birth weight infants.

Journal Article Cardiol Young · November 2017 BACKGROUND: In very low birth weight infants, persistence of a patent ductus arteriosus results in morbidity and mortality. Therapies to close the ductus are effective, but clinical outcomes may depend on the accuracy of diagnosis and the timing of adminis ... Full text Link to item Cite

Early Caffeine Prophylaxis and Risk of Failure of Initial Continuous Positive Airway Pressure in Very Low Birth Weight Infants.

Journal Article J Pediatr · November 2017 OBJECTIVE: To test the hypothesis that early caffeine treatment on the day of birth, compared with later treatment in very low birth weight (VLBW, <1500 g) infants receiving continuous positive airway pressure (CPAP) therapy, is associated with a decreased ... Full text Link to item Cite

Use of Population Pharmacokinetics and Electronic Health Records to Assess Piperacillin-Tazobactam Safety in Infants.

Journal Article Pediatr Infect Dis J · September 2017 BACKGROUND: Piperacillin, in combination with tazobactam, is frequently used in infants for treating nosocomial infections, although safety data in this population are limited. Electronic health record (EHR) data can be used to evaluate drug safety in infa ... Full text Link to item Cite

Population Pharmacokinetics of Dexmedetomidine in Infants.

Journal Article J Clin Pharmacol · September 2017 Despite limited pharmacokinetic (PK) data, dexmedetomidine is increasingly being used off-label for sedation in infants. We aimed to characterize the developmental PK changes of dexmedetomidine during infancy. In this open-label, single-center PK study of ... Full text 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

Late-onset Sepsis in Extremely Premature Infants: 2000-2011.

Journal Article Pediatr Infect Dis J · August 2017 BACKGROUND: Late-onset sepsis (LOS) is an important cause of death and neurodevelopmental impairment in premature infants. The purpose of this study was to assess overall incidence of LOS, distribution of LOS-causative organisms and center variation in inc ... Full text Link to item Cite

Antihypertensive drug exposure in premature infants from 1997 to 2013.

Journal Article Cardiol Young · July 2017 BACKGROUND: Systemic hypertension is increasingly recognised in premature infants. There is limited evidence regarding treatment, and most published treatment recommendations are based solely on expert opinions. METHODS: We identified all infants born ⩽32 ... Full text Link to item Cite

In-hospital outcomes of premature infants with severe bronchopulmonary dysplasia.

Journal Article J Perinatol · July 2017 OBJECTIVE: To characterize in-hospital outcomes of premature infants diagnosed with severe bronchopulmonary dysplasia (BPD). STUDY DESIGN: Retrospective cohort study including premature infants with severe BPD discharged from 348 Pediatrix Medical Group ne ... Full text Open Access 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

Association of in utero magnesium exposure and spontaneous intestinal perforations in extremely low birth weight infants.

Journal Article J Perinatol · June 2017 OBJECTIVE: The objective of this study is to determine whether antenatal exposure to magnesium is associated with spontaneous intestinal perforation (SIP) in extremely low birth weight (ELBW) infants (⩽1000 g). STUDY DESIGN: We identified all ELBW infants ... Full text Link to item 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

Respiratory Support for Very Low Birth Weight Infants Receiving Dexamethasone.

Journal Article J Pediatr · April 2017 OBJECTIVE: To assess how neonatal intensive care units followed the American Academy of Pediatrics guidelines for use of dexamethasone in preterm infants by evaluating respiratory support at the time of dexamethasone administration. STUDY DESIGN: This is a ... 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

Dolichocephaly in Preterm Infants: Prevalence, Risk Factors, and Early Motor Outcomes.

Journal Article Am J Perinatol · March 2017 Objective The purpose of this study was to determine when dolichocephaly develops in preterm infants, to establish factors that contribute to its development, and to determine its association with adverse motor outcomes. Study Design This study was a retro ... Full text Link to item Cite

Survival and Neurodevelopmental Outcomes among Periviable Infants.

Journal Article N Engl J Med · February 16, 2017 BACKGROUND: Data reported during the past 5 years indicate that rates of survival have increased among infants born at the borderline of viability, but less is known about how increased rates of survival among these infants relate to early childhood neurod ... 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

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

Sedation, Analgesia, and Paralysis during Mechanical Ventilation of Premature Infants.

Journal Article J Pediatr · January 2017 OBJECTIVE: To characterize administration of sedatives, analgesics, and paralytics in a large cohort of mechanically ventilated premature infants. STUDY DESIGN: Retrospective cohort study including all infants <1500 g birth weight and <32 weeks gestational ... Full text Link to item Cite

Safety of Enalapril in Infants Admitted to the Neonatal Intensive Care Unit.

Journal Article Pediatr Cardiol · January 2017 Enalapril is used to treat hypertension and congestive heart failure in infants. However, enalapril is not labeled for neonates, and safety data in infants are sparse. To evaluate the safety of enalapril in young infants, we conducted a retrospective cohor ... Full text Link to item Cite

A case of infant delirium in the neonatal intensive care unit.

Journal Article J Neonatal Perinatal Med · 2017 Infant delirium is an under-recognized clinical entity in neonatal intensive care, and earlier identification and treatment could minimize morbidities associated with this condition. We describe a case of a 6-month-old former 32 weeks gestation infant unde ... Full text Link to item Cite

Survival and neurodevelopmental outcomes among periviable infants

Journal Article Obstetrical and Gynecological Survey · January 1, 2017 Full text Cite

A Weight Estimation Strategy for Preterm and Full-Term Infants.

Journal Article Glob Pediatr Health · 2017 Weight is the foremost marker of health outcomes in infants; however, the majority of community workers and health care providers in remote, resource-constrained settings have limited access to functional scales. This study develops and validates a simple ... Full text Link to item Cite

Gastrostomy tube placement in infants with congenital diaphragmatic hernia: Frequency, predictors, and growth outcomes.

Journal Article Early Hum Dev · December 2016 BACKGROUND: Gastrostomy tube (G-tube) placement is a common intervention for newborns with severe feeding difficulties. Infants with congenital diaphragmatic hernia (CDH) are at high risk for feeding problems. Prevalence of G-tube placement and consequent ... 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

Frequent Activation Delay-Induced Mechanical Dyssynchrony and Dysfunction in the Systemic Right Ventricle.

Journal Article J Am Soc Echocardiogr · November 2016 BACKGROUND: Patients with systemic right ventricles frequently experience progressive heart failure and conduction abnormalities leading to abnormal ventricular activation. Activation delay-induced mechanical dyssynchrony can contribute to ventricular fail ... Full text Link to item Cite

Cardiopulmonary resuscitation in hospitalized infants.

Journal Article Early Hum Dev · October 2016 BACKGROUND: Hospitalized infants requiring cardiopulmonary resuscitation (CPR) represent a high-risk group. Recent data on risk factors for mortality following CPR in this population are lacking. AIMS: We hypothesized that infant demographic characteristic ... 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

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

Risk Factors and In-Hospital Outcomes following Tracheostomy in Infants.

Journal Article J Pediatr · June 2016 OBJECTIVE: To describe the epidemiology, risk factors, and in-hospital outcomes of tracheostomy in infants in the neonatal intensive care unit. STUDY DESIGN: We analyzed electronic medical records from 348 neonatal intensive care units for the period 1997 ... 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

Daily mortality of infants born at less than 30weeks' gestation.

Journal Article Early Hum Dev · May 2016 BACKGROUND: Few studies have reported odds of mortality for hospitalized premature infants stratified by postnatal age and adjusted for severity of illness. Our objective was to examine day-by-day mortality of premature infants in a large multicenter cohor ... Full text Link to item Cite

Special article: 2014 Pediatric Clinical Trials Forum.

Journal Article Pediatr Res · April 2016 In November 2014, the American Academy of Pediatrics convened key stakeholders to discuss the feasibility of accelerating children's medical advances by creating an independent global Pediatric Clinical Trials Network. The Forum identified challenges posed ... 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

Improved survival and neurodevelopmental outcomes among extremely premature infants born near the limit of viability.

Journal Article Early Hum Dev · April 2016 BACKGROUND: Infants born near the limit of viability are at high risk for death or adverse neurodevelopmental outcomes. It is unclear whether these outcomes have improved over the past 15 years. AIM: To determine if death and neurodevelopmental impairment ... Full text Link to item Cite

Insulin, Hyperglycemia, and Severe Retinopathy of Prematurity in Extremely Low-Birth-Weight Infants.

Journal Article Am J Perinatol · March 2016 OBJECTIVE: This study aims to determine the association between hyperglycemia, insulin therapy, and severe retinopathy of prematurity (ROP) in extremely low-birth-weight (ELBW) infants. STUDY DESIGN: In this retrospective database study, we included all EL ... Full text Link to item Cite

Enteral Feeding with Human Milk Decreases Time to Discharge in Infants following Gastroschisis Repair.

Journal Article J Pediatr · March 2016 OBJECTIVE: To assess the effect of enteral feeding with human milk on the time from initiation of feeds to discharge after gastroschisis repair through review of a multi-institutional database. STUDY DESIGN: Infants who underwent gastroschisis repair betwe ... Full text Link to item Cite

Optimizing operational efficiencies in early phase trials: The Pediatric Trials Network experience.

Journal Article Contemp Clin Trials · March 2016 Performing drug trials in pediatrics is challenging. In support of the Best Pharmaceuticals for Children Act, the Eunice Kennedy Shriver National Institute of Child Health and Human Development funded the formation of the Pediatric Trials Network (PTN) in ... Full text Link to item Cite

Sustained Reduction in Bloodstream Infections in Infants at a Large Tertiary Care Neonatal Intensive Care Unit.

Journal Article Adv Neonatal Care · February 2016 BACKGROUND: Bloodstream infections (BSI) cause significant morbidity and mortality among hospitalized infants. PURPOSE: Reduction of BSIs has emerged as an important patient safety goal. Implementation of central line insertion bundles, standardized line c ... Full text Link to item Cite

Sildenafil and retinopathy of prematurity risk in very low birth weight infants.

Journal Article J Perinatol · February 2016 OBJECTIVE: To examine the effect of sildenafil therapy on development of severe retinopathy of prematurity (ROP) requiring surgical intervention in premature infants. STUDY DESIGN: We identified premature infants who were discharged from Pediatrix Medical ... Full text Link to item Cite

Gabapentin Use in the Neonatal Intensive Care Unit.

Journal Article J Pediatr · February 2016 Gabapentin was used for the treatment of term and preterm infants with suspected visceral hyperalgesia caused by a variety of neurologic and gastrointestinal morbidities. Improved feeding tolerance and decreased irritability were seen, as well as decreased ... 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

Comparative effectiveness and safety of indomethacin versus ibuprofen for the treatment of patent ductus arteriosus.

Journal Article Early Hum Dev · December 2015 BACKGROUND: Patent ductus arteriosus (PDA) is common in extremely premature infants and associated with increased morbidity and mortality. Medical management of PDA uses either indomethacin or ibuprofen. Despite numerous studies, uncertainty exists as to w ... 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

Effect of Catheter Dwell Time on Risk of Central Line-Associated Bloodstream Infection in Infants.

Journal Article Pediatrics · December 2015 BACKGROUND AND OBJECTIVE: Central venous catheters in the NICU are associated with significant morbidity and mortality because of the risk of central line-associated bloodstream infections (CLABSIs). The purpose of this study was to determine the effect of ... Full text Link to item Cite

Right ventricular echocardiographic indices predict poor outcomes in infants with persistent pulmonary hypertension of the newborn.

Journal Article Eur Heart J Cardiovasc Imaging · November 2015 AIMS: Infants with persistent pulmonary hypertension of the newborn (PPHN) have elevated pulmonary vascular resistance that can lead to right ventricular (RV) failure and death. Clinicians must decide which infants will fail conventional therapy and requir ... 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

Association between positive urine cultures and necrotizing enterocolitis in a large cohort of hospitalized infants.

Journal Article Early Hum Dev · October 2015 OBJECTIVE: We used a large research database to examine the association between urinary tract infections and necrotizing enterocolitis (NEC) in premature infants. METHODS: This retrospective data analysis included infants ≤32week gestational age and ≤1500g ... 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

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

Between-hospital variation in treatment and outcomes in extremely preterm infants

Journal Article Obstetrical and Gynecological Survey · September 1, 2015 Full text Cite

Increasing incidence of the neonatal abstinence syndrome in U.S. neonatal ICUs

Journal Article Obstetrical and Gynecological Survey · September 1, 2015 Full text Cite

Immunization Status at Discharge from the Neonatal Intensive Care Unit (NICU)

Journal Article PHARMACOEPIDEMIOLOGY AND DRUG SAFETY · September 1, 2015 Link to item Cite

Sedatives and Analgesics Given to Infants in Neonatal Intensive Care Units at the End of Life.

Journal Article J Pediatr · August 2015 OBJECTIVE: To describe the administration of sedatives and analgesics at the end of life in a large cohort of infants in North American neonatal intensive care units. STUDY DESIGN: Data on mortality and sedative and analgesic administration were from infan ... Full text Link to item Cite

Adverse Events After Routine Immunization of Extremely Low-Birth-Weight Infants.

Journal Article JAMA Pediatr · August 2015 IMPORTANCE: Immunization of extremely low-birth-weight (ELBW) infants in the neonatal intensive care unit (NICU) is associated with adverse events, including fever and apnea or bradycardia, in the immediate postimmunization period. These adverse events pre ... Full text Link to item Cite

Pediatric post-marketing safety systems in North America: assessment of the current status.

Journal Article Pharmacoepidemiol Drug Saf · August 2015 PURPOSE: It is critical to have pediatric post-marketing safety systems that contain enough clinical and epidemiological detail to draw regulatory, public health, and clinical conclusions. The pediatric safety surveillance workshop (PSSW), coordinated by t ... Full text Link to item Cite

Safety of octreotide in hospitalized infants.

Journal Article Early Hum Dev · July 2015 BACKGROUND: Octreotide is used off-label in infants for treatment of chylothorax, congenital hyperinsulinism, and gastrointestinal bleeding. The safety profile of octreotide in hospitalized infants has not been described; we sought to fill this information ... Full text Link to item Cite

Necrotizing enterocolitis in infants with ductal-dependent congenital heart disease.

Journal Article Am J Perinatol · June 2015 OBJECTIVE: Infants with congenital heart disease (CHD) receiving prostaglandins (PGEs) may be at an increased risk for necrotizing enterocolitis (NEC). Enteral feeding may further increase the risk of NEC in these patients. We evaluated the incidence of NE ... Full text Link to item Cite

Treatment of supraventricular tachycardia in infants: Analysis of a large multicenter database.

Journal Article Early Hum Dev · June 2015 OBJECTIVE: Supraventricular tachycardia (SVT) is the most common arrhythmia in infants. Infants are typically treated with antiarrhythmic medications, but there is a lack of evidence guiding management, thus exposing infants to risks of both inadequate the ... Full text Link to item Cite

Increasing incidence of the neonatal abstinence syndrome in U.S. neonatal ICUs.

Journal Article N Engl J Med · May 28, 2015 BACKGROUND: The incidence of the neonatal abstinence syndrome, a drug-withdrawal syndrome that most commonly occurs after in utero exposure to opioids, is known to have increased during the past decade. However, recent trends in the incidence of the syndro ... Full text Link to item Cite

Between-hospital variation in treatment and outcomes in extremely preterm infants.

Journal Article N Engl J Med · May 7, 2015 BACKGROUND: Between-hospital variation in outcomes among extremely preterm infants is largely unexplained and may reflect differences in hospital practices regarding the initiation of active lifesaving treatment as compared with comfort care after birth. M ... 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

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

Impact of a palliative care program on end-of-life care in a neonatal intensive care unit.

Journal Article J Perinatol · March 2015 OBJECTIVE: Evaluate changes in end-of-life care following initiation of a palliative care program in a neonatal intensive care unit. STUDY DESIGN: Retrospective study comparing infant deaths before and after implementation of a Palliative Care Program comp ... 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

Diuretic exposure in premature infants from 1997 to 2011.

Journal Article Am J Perinatol · January 2015 OBJECTIVE: Diuretics are often prescribed off-label to premature infants, particularly to prevent or treat bronchopulmonary dysplasia. We examined their use and safety in this group. STUDY DESIGN: Retrospective cohort study of infants < 32 weeks gestation ... Full text Link to item Cite

Dosing in neonates: special considerations in physiology and trial design.

Journal Article Pediatr Res · January 2015 Determining the right dose for drugs used to treat neonates is critically important. Neonates have significant differences in physiology affecting drug absorption, distribution, metabolism, and elimination that make extrapolating dosages from adults and ol ... Full text 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

Baseline Urinary Glucose Tetrasaccharide Concentrations in Patients with Infantile- and Late-Onset Pompe Disease Identified by Newborn Screening.

Chapter · 2015 PURPOSE: The urinary glucose tetrasaccharide, Glcα1-6Glcα1-4Glcα1-4Glc (Glc4), is a biomarker of glycogen accumulation and tissue damage and is elevated in patients with Pompe disease. We report baseline urinary Glc4 concentrations for patients with classi ... Full text Link to item Cite

Clinical outcomes in very low birth weight infants with major congenital heart defects.

Journal Article Early Hum Dev · December 2014 BACKGROUND: The combination of major congenital heart disease (CHD) and prematurity is associated with poor prognosis, but previous studies have not fully characterized morbidity and mortality in this population. We conducted a retrospective cohort study o ... Full text Link to item Cite

Comparative effectiveness of digoxin and propranolol for supraventricular tachycardia in infants.

Conference Pediatr Crit Care Med · November 2014 OBJECTIVES: Supraventricular tachycardia is the most common arrhythmia in infants, and antiarrhythmic medications are frequently used for prophylaxis. The optimal prophylactic antiarrhythmic medication is unknown, and prior randomized trials have been unde ... Full text Link to item Cite

Predictive performance of a gentamicin population pharmacokinetic model in neonates receiving full-body hypothermia.

Journal Article Ther Drug Monit · October 2014 BACKGROUND: Population pharmacokinetic (popPK) models derived from small pharmacokinetics (PK) studies in neonates are often underpowered to detect clinically important characteristics that drive dosing. External validation of such models is crucial. In th ... Full text Link to item Cite

A systematic review of randomized controlled trials for the prevention of bronchopulmonary dysplasia in infants.

Journal Article J Perinatol · September 2014 OBJECTIVE: Bronchopulmonary dysplasia (BPD) is the most common cause of pulmonary morbidity in premature infants and is associated with life-long morbidities. Developing drugs for the prevention of BPD would improve public health. We sought to determine ch ... Full text Link to item Cite

Frequency of anomalies and hospital outcomes in infants with gastroschisis and omphalocele.

Journal Article Early Hum Dev · August 2014 BACKGROUND: Gastroschisis and omphalocele are the most common anterior abdominal wall defects affecting infants. There are few large cohort studies describing the frequency of associated anomalies in infants with these 2 conditions. We describe associated ... 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

Feeding practices and other risk factors for developing transfusion-associated necrotizing enterocolitis.

Journal Article Early Hum Dev · May 2014 AIMS: The objective of this study is to determine the incidence of and risk factors for necrotizing enterocolitis (NEC) and transfusion-associated NEC (TANEC) in very-low-birth-weight (VLBW) infants pre/post implementation of a peri-transfusion feeding pro ... 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

Pharmacokinetics and safety of recently approved drugs used to treat methicillin-resistant Staphylococcus aureus infections in infants, children and adults.

Journal Article Expert Rev Clin Pharmacol · May 2014 Methicillin-resistant Staphylococcus aureus (MRSA) remains a significant cause of morbidity in hospitalized infants. Over the past 15 years, several drugs have been approved for the treatment of S. aureus infections in adults (linezolid, quinupristin/dalfo ... 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

Current epidemiology and management of invasive candidiasis in infants

Journal Article Current Fungal Infection Reports · March 1, 2014 Invasive candidiasis (IC) is common in premature infants and is associated with significant morbidity and mortality. Although the incidence of IC in infants is decreasing, there is marked variability in number of cases by center and geographical region, an ... Full text Cite

Drug labeling and exposure in neonates.

Journal Article JAMA Pediatr · February 2014 IMPORTANCE: Federal legislation has led to a notable increase in pediatric studies submitted to the Food and Drug Administration (FDA), resulting in new pediatric information in product labeling. However, approximately 50% of drug labels still have insuffi ... Full text Link to item Cite

Sustained unresponsiveness to peanut in subjects who have completed peanut oral immunotherapy.

Journal Article J Allergy Clin Immunol · February 2014 BACKGROUND: Although peanut oral immunotherapy (OIT) has been conclusively shown to cause desensitization, it is currently unknown whether clinical protection persists after stopping therapy. OBJECTIVE: Our primary objective was to determine whether peanut ... 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

Catheter dwell time and CLABSIs in neonates with PICCs: a multicenter cohort study.

Journal Article Pediatrics · December 2013 OBJECTIVE: To determine whether the daily risk of central line-associated bloodstream infections (CLABSIs) increases over the dwell time of peripherally inserted central catheters (PICCs) in high-risk neonates. METHODS: Multicenter retrospective cohort inc ... Full text Link to item Cite

Reducing central line-associated bloodstream infections in North Carolina NICUs.

Journal Article Pediatrics · December 2013 OBJECTIVE: Central lines in NICUs have long dwell times. Success in reducing central line-associated bloodstream infections (CLABSIs) requires a multidisciplinary team approach to line maintenance and insertion. The Perinatal Quality Collaborative of North ... Full text Link to item Cite

Early administration of oropharyngeal colostrum to extremely low birth weight infants.

Journal Article Breastfeed Med · December 2013 BACKGROUND: Human milk reduces morbidities in extremely low birth weight (ELBW) infants. However, clinical instability often precludes ELBW infants from receiving early enteral feeds. This study compared clinical outcomes before and after implementing an o ... Full text 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

Individual and center-level factors affecting mortality among extremely low birth weight infants.

Journal Article Pediatrics · July 2013 OBJECTIVE: To examine factors affecting center differences in mortality for extremely low birth weight (ELBW) infants. METHODS: We analyzed data for 5418 ELBW infants born at 16 Neonatal Research Network centers during 2006-2009. The primary outcomes of ea ... 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

Duration of empirical antibiotic therapy for infants suspected of early-onset sepsis.

Journal Article Curr Opin Pediatr · April 2013 PURPOSE OF REVIEW: Clinicians' adherence to the Centers for Disease Control guidelines to prevent group B Streptococcus (GBS) early-onset sepsis (EOS) has reduced GBS EOS. Although evidence-based testing and empirical antibiotic initiation are likely savin ... Full text Link to item Cite

Perinatal factors associated with poor neurocognitive outcome in early school age congenital diaphragmatic hernia survivors.

Journal Article J Pediatr Surg · April 2013 OBJECTIVE: Determine predictors of neurocognitive outcome in early school age congenital diaphragmatic hernia (CDH) survivors. STUDY DESIGN: Prospective study of infants with CDH at Duke University Medical Center. Neurocognitive delay (NCD) at school age ( ... Full text Link to item Cite

Migraine therapeutics in adolescents: a systematic analysis and historic perspectives of triptan trials in adolescents.

Journal Article JAMA Pediatr · March 1, 2013 OBJECTIVES To conduct a systematic review and analysis of trial data submitted to the US Food and Drug Administration (FDA) to identify possible causes for the failure of pediatric trials of triptans for treatment of migraines. DATA SOURCE The FDA website ... Full text Link to item Cite

Predictors of Clinical Tolerance After Peanut Oral Immunotherapy

Conference Journal of Allergy and Clinical Immunology · February 2013 Full text Cite

Outcomes and Safety of Oral Food Challenges in a University-Based Clinic

Conference Journal of Allergy and Clinical Immunology · February 2013 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

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

Isoflurane for life-threatening bronchospasm: a 15-year single-center experience.

Journal Article Respir Care · November 2012 BACKGROUND: Children with severe bronchospasm requiring mechanical ventilation may become refractory to conventional therapy. In these critically ill patients, isoflurane is an inhaled anesthetic agent available in some centers to treat bronchospasm. We hy ... 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

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

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

Approach to infants born at 22 to 24 weeks' gestation: relationship to outcomes of more-mature infants.

Journal Article Pediatrics · June 2012 OBJECTIVE: We sought to determine if a center's approach to care of premature infants at the youngest gestational ages (22-24 weeks' gestation) is associated with clinical outcomes among infants of older gestational ages (25-27 weeks' gestation). METHODS: ... 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

Toll-like receptor 1 polymorphisms increase susceptibility to candidemia.

Journal Article J Infect Dis · March 15, 2012 BACKGROUND: Candidemia is a severe invasive fungal infection with high mortality. Recognition of Candida species is mediated through pattern recognition receptors such as Toll-like receptors (TLRs). This study assessed whether genetic variation in TLR sign ... Full text Link to item Cite

Impediments to clinical research in the United States.

Journal Article Clin Pharmacol Ther · March 2012 Clinical trials are essential to the evaluation of promising scientific discoveries, but they are becoming unsustainably burdensome, threatening to deprive patients and health-care providers of new therapies and new evidence to guide the use of existing tr ... Full text Link to item Cite

Characteristics of patients who die of necrotizing enterocolitis.

Journal Article J Perinatol · March 2012 OBJECTIVE: Necrotizing enterocolitis (NEC) is associated with high morbidity and mortality among infants admitted for intensive care. The factors associated with mortality and catastrophic presentation remain poorly understood. Our objective was to describ ... 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

Antibiotic use and misuse in the neonatal intensive care unit.

Journal Article Clin Perinatol · March 2012 Neonatal sepsis causes significant morbidity and mortality, especially in preterm infants. Clinicians are compelled to treat with empiric antibiotics at the first signs of suspected sepsis. Broad-spectrum antibiotics and prolonged treatment with empiric an ... Full text Link to item Cite

Bias flow does not affect ventilation during high-frequency oscillatory ventilation in a pediatric animal model of acute lung injury.

Journal Article Pediatr Crit Care Med · March 2012 OBJECTIVE: During high-frequency oscillatory ventilation, bias flow is the continuous flow of gas responsible for replenishing oxygen and removing CO(2) from the patient circuit. Bias flow is usually set at 20 L/min, but many patients require neuromuscular ... Full text Link to item Cite

Cytokine gene polymorphisms and the outcome of invasive candidiasis: a prospective cohort study.

Journal Article Clin Infect Dis · February 15, 2012 BACKGROUND:  Candida bloodstream infections cause significant morbidity and mortality among hospitalized patients. Although clinical and microbiological factors affecting prognosis have been identified, the impact of genetic variation in the innate immune ... Full text Open Access 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

Candida Species

Chapter · January 1, 2012 Full text Cite

Targeted interventions improve shared agreement of daily goals in the pediatric intensive care unit.

Journal Article Pediatr Crit Care Med · January 2012 OBJECTIVE: To improve communication during daily rounds using sequential interventions. DESIGN: Prospective cohort study. SETTING: Multidisciplinary pediatric intensive care unit in a university hospital. SUBJECTS: The multidisciplinary rounding team in th ... Full text Link to item 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

Genetic variation in the dectin-1/CARD9 recognition pathway and susceptibility to candidemia.

Journal Article J Infect Dis · October 1, 2011 BACKGROUND: Candidemia is an important cause of morbidity and mortality in critically ill patients or patients undergoing invasive treatments. Dectin-1 is the main β-glucan receptor, and patients with a complete deficiency of either dectin-1 or its adaptor ... 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 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

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

Journal Article Infect Control Hosp Epidemiol · July 2011 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

Cardiovascular abnormalities in late-onset Pompe disease and response to enzyme replacement therapy.

Journal Article Genet Med · July 2011 PURPOSE: We evaluated the prevalence of cardiovascular abnormalities and the efficacy and safety of enzyme replacement therapy in patients with late-onset Pompe disease. METHODS: Ninety patients were randomized 2:1 to enzyme replacement therapy or placebo ... Full text Link to item Cite

Prediction of bronchopulmonary dysplasia by postnatal age in extremely premature infants.

Journal Article Am J Respir Crit Care Med · June 15, 2011 RATIONALE: Benefits of identifying risk factors for bronchopulmonary dysplasia in extremely premature infants include providing prognostic information, identifying infants likely to benefit from preventive strategies, and stratifying infants for clinical t ... 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 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

Treatment of patent ductus arteriosus with bidirectional flow in neonates.

Journal Article Early Hum Dev · May 2011 BACKGROUND: Patent ductus arteriosus is a common occurrence among prematurely born neonates and is believed to play a role in the development of other complications of prematurity including intraventricular hemorrhage, bronchopulmonary dysplasia, and necro ... Full text Link to item Cite

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

Journal Article Clin Pharmacol Ther · May 2011 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 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 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

Recombinant activated factor VIIa treatment for refractory hemorrhage in infants.

Journal Article J Perinatol · March 2011 OBJECTIVE: Report clinical response to recombinant factor VIIa in a cohort of critically ill infants. STUDY DESIGN: We identified all infants who received factor VIIa in the Duke Neonatal Intensive Care Unit between January 2005 and July 2008. Hematologica ... Full text Link to item Cite

Arrhythmias in patients with hypoplastic left heart syndrome.

Journal Article Am Heart J · January 2011 BACKGROUND: Mortality between stage I and II palliation for hypoplastic left heart syndrome (HLHS) has been associated with arrhythmias. The stage-related proportion, associations, and clinical impact of arrhythmias in patients with HLHS have not been eval ... 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

Adaptation of a postoperative handoff communication process for children with heart disease: a quantitative study.

Journal Article Am J Med Qual · 2011 Handoff communication is a point of vulnerability when valuable patient information can be inaccurate or omitted. An institutional protocol was implemented in 2005 to improve the handoff from the operating room to the intensive care unit after pediatric ca ... Full text Link to item Cite

In reply

Journal Article Pediatrics · January 1, 2011 Full text Cite

Prevalence of iron deficiency in children with Down syndrome.

Journal Article J Pediatr · December 2010 OBJECTIVES: To determine the prevalence of iron deficiency (ID) and iron deficiency anemia (IDA) in a sample of children with Down syndrome (DS) and to evaluate the effect of macrocytosis on the diagnosis of ID/IDA in these children. STUDY DESIGN: Children ... Full text Link to item Cite

The (1,3){beta}-D-glucan test as an aid to early diagnosis of invasive fungal infections following lung transplantation.

Journal Article J Clin Microbiol · November 2010 The Fungitell assay for (1,3)β-D-glucan (BG) detection in serum has been evaluated in patients with invasive fungal infections (IFIs) and healthy controls and for the early diagnosis of IFI in cancer patients. We evaluated the BG assay for the detection of ... Full text Link to item Cite

Vasopressin for refractory hypotension in extremely low birth weight infants.

Journal Article J Pediatr · September 2010 Intravenous vasopressin at 0.01 to 0.04 units/kg/h increased median mean blood pressure from 26 mm Hg (range 18-44) to 41 mm Hg (range 17-90) by 12 hours of infusion (P=.002) and allowed weaning of catecholamines in a group of extremely low birth weight in ... 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

Protocolized approach to the management of congenital diaphragmatic hernia: benefits of reducing variability in care.

Journal Article J Pediatr Surg · June 2010 PURPOSE: Variable approaches to the care of infants with congenital diaphragmatic hernia (CDH) by multiple providers may contribute to inconsistent care. Our institution developed a comprehensive evidence-based protocol to standardize the management of CDH ... Full text Link to item Cite

Population pharmacokinetics of micafungin in neonates and young infants.

Journal Article Antimicrob Agents Chemother · June 2010 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

Long-term morbidities associated with vocal cord paralysis after surgical closure of a patent ductus arteriosus in extremely low birth weight infants.

Journal Article J Perinatol · June 2010 OBJECTIVE: Determine associations between left vocal cord paralysis (LVCP) and poor respiratory, feeding and/or developmental outcomes in extremely low birth weight (ELBW) infants following surgical closure of a patent ductus arteriosus (PDA). STUDY DESIGN ... Full text Link to item Cite

Safety and effectiveness of indomethacin versus ibuprofen for treatment of patent ductus arteriosus.

Journal Article Am J Perinatol · May 2010 We compared the rates of medical closure of patent ductus arteriosus (PDA) and complications (renal dysfunction, necrotizing enterocolitis, spontaneous intestinal perforation, and intraventricular hemorrhage) between infants treated with indomethacin and i ... Full text Link to item Cite

Preliminary observations of the use of high-frequency jet ventilation as rescue therapy in infants with congenital diaphragmatic hernia.

Journal Article J Pediatr Surg · April 2010 BACKGROUND/PURPOSE: Congenital diaphragmatic hernia (CDH) is associated with mortality of 10% to 50%. Several investigators have reported outcomes from centers using high-frequency oscillatory ventilation in their management of CDH, but there are no recent ... 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 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

End-tidal and arterial carbon dioxide measurements correlate across all levels of physiologic dead space.

Journal Article Respir Care · March 2010 BACKGROUND: End-tidal carbon dioxide (P(ETCO(2))) is a surrogate, noninvasive measurement of arterial carbon dioxide (P(aCO(2))), but the clinical applicability of P(ETCO(2)) in the intensive care unit remains unclear. Available research on the relationshi ... 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

Performance of the AST-to-platelet ratio index as a noninvasive marker of fibrosis in pediatric patients with chronic viral hepatitis.

Journal Article J Pediatr Gastroenterol Nutr · March 2010 We investigated the performance of aspartate aminotransferase to platelet ratio index (APRI) as a noninvasive marker of fibrosis and cirrhosis in children with chronic viral hepatitis. All of the patients 0 to 20 years old with chronic hepatitis B or C pre ... Full text Link to item Cite

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

Journal Article Clin Pharmacol Ther · January 2010 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

Prevention of bronchopulmonary dysplasia.

Journal Article Semin Fetal Neonatal Med · December 2009 Considerable effort has been devoted to the development of strategies to reduce the incidence of bronchopulmonary dysplasia (BPD), including use of medications, nutritional therapies, and respiratory care practices. Unfortunately, most of these strategies ... 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

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

Journal Article Pediatr Infect Dis J · August 2009 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

Transpyloric tube feeding in very low birthweight infants with suspected gastroesophageal reflux: impact on apnea and bradycardia.

Journal Article J Perinatol · May 2009 OBJECTIVE: Our aim was to assess the safety and efficacy of transpyloric tube feeding as a therapeutic option to reduce apnea and bradycardia in hospitalized very low birthweight (VLBW) infants with clinical signs suggestive of gastroesophageal reflux (GER ... 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

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

Candida Species

Chapter · January 1, 2009 Full text Cite

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

Journal Article Pediatr Infect Dis J · December 2008 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

Vocal fold paralysis following surgical ductal closure in extremely low birth weight infants: a case series of feeding and respiratory complications.

Journal Article J Perinatol · November 2008 Surgical closure of a patent ductus arteriosus (PDA) continues to be a frequent procedure among extremely preterm infants. Recent evidence indicates surgical closure is associated with worse outcomes than after medical closure. Left vocal fold paralysis is ... Full text Link to item Cite

Safety monitoring of drugs receiving pediatric marketing exclusivity.

Journal Article Pediatrics · September 2008 Featured Publication 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

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

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

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

Dynamic change of fecal calprotectin in very low birth weight infants during the first month of life.

Journal Article Neonatology · 2008 BACKGROUND: Calprotectin is a cytosolic component of neutrophils. Fecal calprotectin (FC) level is a useful marker for exacerbation of inflammatory bowel disease in children. FC may be a useful marker for necrotizing enterocolitis (NEC). OBJECTIVE: To dete ... Full text Link to item Cite

Statistical analysis methods for QT/QTc prolongation.

Journal Article J Biopharm Stat · 2008 Prolonged QT interval is associated with life-threatening arrhythmias. Regulatory authorities have paid special attention to investigating the drug-induced delay of cardiac repolarization. Studies aimed at evaluating QT prolongation have become a routine p ... Full text Link to item Cite

Mortality and neurodevelopmental outcome after Staphylococcus aureus bacteremia in infants.

Journal Article Pediatr Infect Dis J · December 2007 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 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

Excess costs of hospital care associated with neonatal candidemia.

Journal Article Pediatr Infect Dis J · March 2007 Featured Publication 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

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 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

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

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

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

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.

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

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

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

Estrogen priming modulates autoreceptor-mediated potentiation of dopamine uptake.

Journal Article Eur J Pharmacol · August 11, 2000 The ability of a physiological dose of estrogen (estradiol benzoate, estrogen: 10 microgram 48 and 24 h prior) to modulate autoreceptor-mediated changes in dopamine transport properties was investigated in a synaptosomal preparation prepared from the nucle ... Full text Link to item Cite