Scholars@Duke
Christoph Paul Vincent Hornik

Christoph Paul Vincent Hornik

Samuel L. Katz Distinguished Professor of Pediatrics
Pediatrics, Critical Care Medicine
christoph.hornik@duke.edu
DCRI PO Box 17969, Durham, NC 27715
Dept of Pediatrics, Durham, NC 27710
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Selected Publications

Framework of the strengths and challenges of clinically integrated trials: An expert panel report.

Journal Article Am Heart J · September 2024 The limitations of the explanatory clinical trial framework include the high expense of implementing explanatory trials, restrictive entry criteria for participants, and redundant logistical processes. These limitations can result in slow evidence generati ... Full text Link to item Cite

Prescribing practices of inhaled corticosteroids for premature infants in the neonatal intensive care unit.

Journal Article J Perinatol · July 2024 OBJECTIVE: Despite limited safety and efficacy data, inhaled corticosteroids (ICS) are prescribed to premature infants in the neonatal intensive care unit (NICU). We examined contemporary use and risk factors for ICS use in the NICU. STUDY DESIGN: Infants ... Full text Link to item Cite

Pediatric Pharmacology for the Primary Care Provider: Advances and Limitations.

Journal Article Pediatrics · July 1, 2024 Despite >1 in 5 children taking prescription drugs in the United States, off-label drug use is common. To increase the study of drugs in children, regulatory bodies have enacted legislation to incentivize and require pediatric drug studies. As a result of ... Full text Link to item Cite

Use of Speckle-Tracking Echocardiography in Septic Cardiomyopathy in Critically Ill Children: A Narrative Review.

Journal Article Crit Care Explor · July 1, 2024 OBJECTIVES: In critically ill children with severe sepsis, septic cardiomyopathy (SCM) denotes the subset of patients who have myocardial dysfunction with poor response to fluid and inotropic support, and higher mortality risk. The objective of this review ... Full text Link to item Cite

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

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

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

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

Incidence of group B streptococcus early-onset sepsis in term neonates with second-line prophylaxis maternal intrapartum antibiotics: a multicenter retrospective study.

Journal Article Am J Obstet Gynecol · June 2024 BACKGROUND: The difference in the incidence of early-onset sepsis caused by group B streptococcus among term neonates whose mothers received first-line vs second-line intrapartum prophylaxis is poorly described. OBJECTIVE: This study aimed to compare the i ... Full text Link to item Cite

Indomethacin Pharmacokinetics and Pharmacodynamics in Pregnancies With Preterm Labor: The Need for Dose-Ranging Trials.

Journal Article J Clin Pharmacol · June 2024 The use of indomethacin to delay delivery in preterm labor (PTL) is widely accepted; however, the optimal dosage of indomethacin in pregnancy is unknown. Here, we perform population pharmacokinetic (PK) and pharmacodynamic (PD) analyses, characterize the p ... Full text Link to item Cite

Application of Physiologically Based Pharmacokinetic Modeling to Characterize the Effects of Age and Obesity on the Disposition of Levetiracetam in the Pediatric Population.

Journal Article Clin Pharmacokinet · June 2024 BACKGROUND: Levetiracetam is an antiseizure medication used for several seizure types in adults and children aged 1 month and older; however, due to a lack of data, pharmacokinetic (PK) variability of levetiracetam is not adequately characterized in certai ... Full text Link to item Cite

Correlating Severity of Pulmonary Hypertension by Echocardiogram with Mortality in Premature Infants with Bronchopulmonary Dysplasia.

Journal Article Am J Perinatol · May 2, 2024 OBJECTIVE:  Bronchopulmonary dysplasia (BPD) is the most common complication of preterm birth. Infants with BPD are at increased risk for pulmonary hypertension (PH). Cardiac catheterization is the gold standard for diagnosing PH, but cardiac catheterizati ... Full text Link to item Cite

A reappraisal of risk factors for hypertension after pediatric acute kidney injury.

Journal Article Pediatr Nephrol · May 2024 BACKGROUND: Acute kidney injury (AKI) is common in hospitalized children and increases the risk of chronic kidney disease (CKD) and hypertension, but little is known about the patient level risk factors for pediatric hypertension after AKI. The aims of thi ... Full text Link to item Cite

A Master Protocol Template for Pediatric ARDS Studies.

Journal Article Respir Care · April 30, 2024 BACKGROUND: Pediatric ARDS is associated with significant morbidity and mortality. High-quality data from clinical trials in children are limited due to numerous barriers to their design and execution. Here we describe the collaborative development of a ma ... Full text Link to item Cite

Opportunistic dried blood spot sampling validates and optimizes a pediatric population pharmacokinetic model of metronidazole.

Journal Article Antimicrob Agents Chemother · April 3, 2024 Pharmacokinetic models rarely undergo external validation in vulnerable populations such as critically ill infants, thereby limiting the accuracy, efficacy, and safety of model-informed dosing in real-world settings. Here, we describe an opportunistic appr ... Full text Link to item Cite

Drug development for major chronic health conditions-aligning with growing public health needs: Proceedings from a multistakeholder think tank.

Journal Article Am Heart J · April 2024 The global pharmaceutical industry portfolio is skewed towards cancer and rare diseases due to more predictable development pathways and financial incentives. In contrast, drug development for major chronic health conditions that are responsible for a larg ... Full text Link to item Cite

Sources of pharmacokinetic and pharmacodynamic variability and clinical pharmacology studies of antiseizure medications in the pediatric population.

Journal Article Clin Transl Sci · April 2024 Multiple treatment options exist for children with epilepsy, including surgery, dietary therapies, neurostimulation, and antiseizure medications (ASMs). ASMs are the first line of therapy, and more than 30 ASMs have U.S. Food and Drug Administration (FDA) ... 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

Pharmacological Management of Cardiac Arrhythmias in the Fetal and Neonatal Periods: A Scientific Statement From the American Heart Association: Endorsed by the Pediatric & Congenital Electrophysiology Society (PACES).

Journal Article Circulation · March 5, 2024 Disorders of the cardiac rhythm may occur in both the fetus and neonate. Because of the immature myocardium, the hemodynamic consequences of either bradyarrhythmias or tachyarrhythmias may be far more significant than in mature physiological states. Treatm ... Full text Link to item Cite

Framework of the strengths and challenges of clinically integrated trials: An expert panel report.

Journal Article Am Heart J · September 2024 The limitations of the explanatory clinical trial framework include the high expense of implementing explanatory trials, restrictive entry criteria for participants, and redundant logistical processes. These limitations can result in slow evidence generati ... Full text Link to item Cite

Prescribing practices of inhaled corticosteroids for premature infants in the neonatal intensive care unit.

Journal Article J Perinatol · July 2024 OBJECTIVE: Despite limited safety and efficacy data, inhaled corticosteroids (ICS) are prescribed to premature infants in the neonatal intensive care unit (NICU). We examined contemporary use and risk factors for ICS use in the NICU. STUDY DESIGN: Infants ... Full text Link to item Cite

Pediatric Pharmacology for the Primary Care Provider: Advances and Limitations.

Journal Article Pediatrics · July 1, 2024 Despite >1 in 5 children taking prescription drugs in the United States, off-label drug use is common. To increase the study of drugs in children, regulatory bodies have enacted legislation to incentivize and require pediatric drug studies. As a result of ... Full text Link to item Cite

Use of Speckle-Tracking Echocardiography in Septic Cardiomyopathy in Critically Ill Children: A Narrative Review.

Journal Article Crit Care Explor · July 1, 2024 OBJECTIVES: In critically ill children with severe sepsis, septic cardiomyopathy (SCM) denotes the subset of patients who have myocardial dysfunction with poor response to fluid and inotropic support, and higher mortality risk. The objective of this review ... Full text Link to item Cite

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

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

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

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

Incidence of group B streptococcus early-onset sepsis in term neonates with second-line prophylaxis maternal intrapartum antibiotics: a multicenter retrospective study.

Journal Article Am J Obstet Gynecol · June 2024 BACKGROUND: The difference in the incidence of early-onset sepsis caused by group B streptococcus among term neonates whose mothers received first-line vs second-line intrapartum prophylaxis is poorly described. OBJECTIVE: This study aimed to compare the i ... Full text Link to item Cite

Indomethacin Pharmacokinetics and Pharmacodynamics in Pregnancies With Preterm Labor: The Need for Dose-Ranging Trials.

Journal Article J Clin Pharmacol · June 2024 The use of indomethacin to delay delivery in preterm labor (PTL) is widely accepted; however, the optimal dosage of indomethacin in pregnancy is unknown. Here, we perform population pharmacokinetic (PK) and pharmacodynamic (PD) analyses, characterize the p ... Full text Link to item Cite

Application of Physiologically Based Pharmacokinetic Modeling to Characterize the Effects of Age and Obesity on the Disposition of Levetiracetam in the Pediatric Population.

Journal Article Clin Pharmacokinet · June 2024 BACKGROUND: Levetiracetam is an antiseizure medication used for several seizure types in adults and children aged 1 month and older; however, due to a lack of data, pharmacokinetic (PK) variability of levetiracetam is not adequately characterized in certai ... Full text Link to item Cite

Correlating Severity of Pulmonary Hypertension by Echocardiogram with Mortality in Premature Infants with Bronchopulmonary Dysplasia.

Journal Article Am J Perinatol · May 2, 2024 OBJECTIVE:  Bronchopulmonary dysplasia (BPD) is the most common complication of preterm birth. Infants with BPD are at increased risk for pulmonary hypertension (PH). Cardiac catheterization is the gold standard for diagnosing PH, but cardiac catheterizati ... Full text Link to item Cite

A reappraisal of risk factors for hypertension after pediatric acute kidney injury.

Journal Article Pediatr Nephrol · May 2024 BACKGROUND: Acute kidney injury (AKI) is common in hospitalized children and increases the risk of chronic kidney disease (CKD) and hypertension, but little is known about the patient level risk factors for pediatric hypertension after AKI. The aims of thi ... Full text Link to item Cite

A Master Protocol Template for Pediatric ARDS Studies.

Journal Article Respir Care · April 30, 2024 BACKGROUND: Pediatric ARDS is associated with significant morbidity and mortality. High-quality data from clinical trials in children are limited due to numerous barriers to their design and execution. Here we describe the collaborative development of a ma ... Full text Link to item Cite

Opportunistic dried blood spot sampling validates and optimizes a pediatric population pharmacokinetic model of metronidazole.

Journal Article Antimicrob Agents Chemother · April 3, 2024 Pharmacokinetic models rarely undergo external validation in vulnerable populations such as critically ill infants, thereby limiting the accuracy, efficacy, and safety of model-informed dosing in real-world settings. Here, we describe an opportunistic appr ... Full text Link to item Cite

Drug development for major chronic health conditions-aligning with growing public health needs: Proceedings from a multistakeholder think tank.

Journal Article Am Heart J · April 2024 The global pharmaceutical industry portfolio is skewed towards cancer and rare diseases due to more predictable development pathways and financial incentives. In contrast, drug development for major chronic health conditions that are responsible for a larg ... Full text Link to item Cite

Sources of pharmacokinetic and pharmacodynamic variability and clinical pharmacology studies of antiseizure medications in the pediatric population.

Journal Article Clin Transl Sci · April 2024 Multiple treatment options exist for children with epilepsy, including surgery, dietary therapies, neurostimulation, and antiseizure medications (ASMs). ASMs are the first line of therapy, and more than 30 ASMs have U.S. Food and Drug Administration (FDA) ... 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

Pharmacological Management of Cardiac Arrhythmias in the Fetal and Neonatal Periods: A Scientific Statement From the American Heart Association: Endorsed by the Pediatric & Congenital Electrophysiology Society (PACES).

Journal Article Circulation · March 5, 2024 Disorders of the cardiac rhythm may occur in both the fetus and neonate. Because of the immature myocardium, the hemodynamic consequences of either bradyarrhythmias or tachyarrhythmias may be far more significant than in mature physiological states. Treatm ... Full text Link to item Cite

Population Pharmacokinetics of Caffeine in Neonates with Congenital Heart Disease and Associations with Acute Kidney Injury.

Journal Article J Clin Pharmacol · March 2024 Cardiac surgery-associated acute kidney injury (CS-AKI) occurs in approximately 65% of neonates undergoing cardiac surgery on cardiopulmonary bypass and contributes to morbidity and mortality. Caffeine may reduce CS-AKI by counteracting adenosine receptor ... 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

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

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

Power analysis for idiographic (within-subject) clinical trials: Implications for treatments of rare conditions and precision medicine.

Journal Article Behav Res Methods · December 2023 Power analysis informs a priori planning of behavioral and medical research, including for randomized clinical trials that are nomothetic (i.e., studies designed to infer results to the general population based on interindividual variabilities). Far fewer ... Full text Link to item Cite

Pharmacokinetics of Oral Vitamin D in Children with Obesity and Asthma.

Journal Article Clin Pharmacokinet · November 2023 BACKGROUND AND OBJECTIVE: Vitamin D insufficiency is common in several pediatric diseases including obesity and asthma. Little data exist describing the pharmacokinetics of oral vitamin D in children or the optimal dosing to achieve therapeutic 25(OH)D tar ... Full text Link to item Cite

You & Me: Test and Treat study protocol for promoting COVID-19 test and treatment access to underserved populations.

Journal Article BMC Public Health · October 28, 2023 BACKGROUND: Infections and deaths from the COVID-19 pandemic have disproportionately affected underserved populations. A community-engaged approach that supports decision making around safe COVID-19 practices is needed to promote equitable access to testin ... Full text Link to item Cite

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

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

Patient level factors increase risk of acute kidney disease in hospitalized children with acute kidney injury.

Journal Article Pediatr Nephrol · October 2023 BACKGROUND: Studies in adults have shown that persistent kidney dysfunction ≥7-90 days following acute kidney injury (AKI), termed acute kidney disease (AKD), increases chronic kidney disease (CKD) and mortality risk. Little is known about the factors asso ... Full text Link to item Cite

A point-of-care pharmacokinetic/pharmacodynamic trial in critically ill children: Study design and feasibility.

Journal Article Contemp Clin Trials Commun · October 2023 BACKGROUND: High-quality, efficient, pharmacokinetic (PK), pharmacodynamic (PD), and safety studies in children are needed. Point-of-care trials in adults have facilitated clinical trial participation for patients and providers, minimized the disruption of ... Full text Link to item Cite

More Than a Headache: Lived Experience of Migraine in Youth.

Journal Article Pediatr Neurol · September 2023 BACKGROUND: Migraine is the leading cause of disability among adolescents and young adults. We aimed to characterize the impact of migraine on the experience of children, adolescents, and caregivers. METHODS: This descriptive qualitative study recruited yo ... Full text Link to item Cite

"Click and mortar" opportunities for digitization and consumerism in trials.

Journal Article Contemp Clin Trials · September 2023 BACKGROUND: Digitization (using novel digital tools and strategies) and consumerism (taking a consumer-oriented approach) are increasingly commonplace in clinical trials, but the implications of these changes are not well described. METHODS: We assembled a ... Full text Link to item Cite

Phase I study of liver depot gene therapy in late-onset Pompe disease.

Journal Article Mol Ther · July 5, 2023 Gene therapy with an adeno-associated virus serotype 8 (AAV8) vector (AAV8-LSPhGAA) could eliminate the need for enzyme replacement therapy (ERT) by creating a liver depot for acid α-glucosidase (GAA) production. We report initial safety and bioactivity of ... Full text Link to item Cite

Association of Urine Biomarkers With Acute Kidney Injury and Fluid Overload in Infants After Cardiac Surgery: A Single Center Ancillary Cohort of the Steroids to Reduce Systemic Inflammation After Infant Heart Surgery Trial.

Journal Article Crit Care Explor · May 2023 UNLABELLED: To examine the association between three perioperative urine biomarker concentrations (urine cystatin C [uCysC], urine neutrophil gelatinase-associated lipocalin [uNGAL], and urine kidney injury molecule 1 [uKIM-1]), and cardiac surgery-associa ... 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

Association between simulated ketamine exposures and oxygen saturations in children.

Journal Article Int J Pharmacokinet · February 2023 AIM: We performed a real-world data analysis to evaluate the relationship between simulated ketamine exposures and oxygen desaturation in children. MATERIALS & METHODS: A previously developed population pharmacokinetic model was used to simulate exposures ... Full text Open Access Link to item Cite

Congenital anomalies of the kidney and urinary tract (CAKUT) in critically ill infants: a multicenter cohort study.

Journal Article Pediatr Nephrol · January 2023 BACKGROUND: The aim of the study was to determine the prevalence of congenital anomalies of the kidney and urinary tract (CAKUT) in the neonatal intensive care unit (NICU) and to evaluate risk factors associated with worse outcomes. We hypothesized that in ... Full text Link to item Cite

Extrapolation of Adult Efficacy Data to Pediatric Systemic Lupus Erythematosus: Evaluating Similarities in Exposure-Response.

Journal Article J Clin Pharmacol · January 2023 To streamline drug development, the United States Food and Drug Administration (FDA) can consider the extrapolation of adult efficacy data to children when the disease and drug effects are sufficiently similar. This study explored whether the relationship ... Full text Link to item Cite

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

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

Using Pharmacokinetic Modeling and Electronic Health Record Data to Predict Clinical and Safety Outcomes after Methylprednisolone Exposure during Cardiopulmonary Bypass in Neonates.

Journal Article Congenit Heart Dis · 2023 BACKGROUND: Infants undergoing cardiac surgery with cardiopulmonary bypass (CPB) frequently receive intraoperative methylprednisolone (MP) to suppress CPB-related inflammation; however, the optimal dosing strategy and efficacy of MP remain unclear. METHODS ... Full text Link to item Cite

Pharmacokinetics and Proposed Dosing of Levetiracetam in Children With Obesity.

Journal Article J Pediatr Pharmacol Ther · 2023 OBJECTIVE: Characterize levetiracetam pharmacokinetics (PK) in children with obesity to inform dosing. METHODS: Children 2 to <21 years old receiving standard of care oral levetiracetam across two opportunistic studies provided blood samples. Levetiracetam ... 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

Pharmacokinetics of hydroxychloroquine in paediatric lupus: data from a novel, direct-to-family clinical trial.

Journal Article Lupus Sci Med · November 2022 OBJECTIVE: Determine the pharmacokinetics (PK) and exposure-response of hydroxychloroquine (HCQ) and desethylhydroxychloroquine (DHCQ) in paediatric SLE (pSLE). METHODS: We conducted an exploratory phase 2, direct-to-family trial. Children enrolled in the ... Full text Link to item Cite

Increasing access and uptake of SARS-CoV-2 at-home tests using a community-engaged approach.

Journal Article Prev Med Rep · October 2022 Inequalities around COVID-19 testing and vaccination persist in the U.S. health system. We investigated whether a community-engaged approach could be used to distribute free, at-home, rapid SARS-CoV-2 tests to underserved populations. Between November 18-D ... Full text Open Access Link to item Cite

Protocol for the Vitamin D Oral Replacement in Asthma (VDORA) study.

Journal Article Contemp Clin Trials · September 2022 Obesity and asthma are epidemic in the United States and obesity is an independent risk factor for asthma. Low vitamin D levels (i.e. serum 25-hydroxyvitamin D) have been reported in patients with reduced lung function, more frequent respiratory infections ... Full text Link to item Cite

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

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

Corrigendum: Abstracts of papers, 2022 Annual Meeting

Journal Article Clinical Pharmacology & Therapeutics · August 2022 Full text Cite

A systematic review of clinical study evidence for pulmonary vasodilator therapy following surgery with cardiopulmonary bypass in children with CHD.

Journal Article Cardiol Young · July 20, 2022 OBJECTIVES: Complications from pulmonary hypertension are one of the leading contributors to morbidity and mortality post-cardiopulmonary bypass surgery in children with CHD. Pulmonary vasodilator therapies are commonly used post-operatively, but the optim ... Full text Link to item Cite

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

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

Association of Sociodemographic Factors With Reported Penicillin Allergy in Pediatric Inpatients.

Journal Article Hosp Pediatr · July 1, 2022 OBJECTIVES: Characterize the association of sociodemographic factors with reported penicillin allergy in pediatric inpatients. METHODS: We conducted a retrospective cohort study of pediatric inpatients admitted to general pediatric units at an academic med ... Full text Link to item Cite

Postoperative Renal Failure, Shunt Type, and Mortality After Norwood Palliation.

Journal Article Ann Thorac Surg · June 2022 BACKGROUND: The Single Ventricle Reconstruction Trial demonstrated increased risk of death or heart transplant 1 year after Norwood among subjects randomly assigned to modified Blalock-Taussig shunts compared with right ventricle to pulmonary artery (RV-PA ... Full text Link to item Cite

Association Between Digoxin Use and Cardiac Function in Infants With Single-Ventricle Congenital Heart Disease During the Interstage Period.

Journal Article Pediatr Crit Care Med · June 1, 2022 OBJECTIVES: To examine the association between digoxin use and cardiac function assessed by echocardiographic indices in infants with single-ventricle (SV) congenital heart disease (CHD) during the interstage period. DESIGN: Retrospective cohort study. SET ... Full text Link to item Cite

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

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

The relationship between simulated milrinone exposure and hypotension in children.

Journal Article Cardiol Young · May 2022 INTRODUCTION: Hypotension is an adverse event that may be related to systemic exposure of milrinone; however, the true exposure-safety relationship is unknown. METHODS: Using the Pediatric Trials Network multicentre repository, we identified children ≤17 y ... Full text Link to item Cite

Development of a Generic Physiologically-Based Pharmacokinetic Model for Lactation and Prediction of Maternal and Infant Exposure to Ondansetron via Breast Milk.

Journal Article Clin Pharmacol Ther · May 2022 Ondansetron is commonly used in breastfeeding mothers to treat nausea and vomiting. There is limited information in humans regarding safety of ondansetron exposure to nursing infants and no adequate study looking at ondansetron pharmacokinetics during lact ... Full text Link to item Cite

Beyond pain control: Outcome and treatment preferences in pediatric migraine.

Journal Article Headache · May 2022 OBJECTIVE: The objective of this study was to describe treatment preferences and perceived quality of existing outcome measures among children and adolescents with migraine and their caregivers. BACKGROUND: Across disciplines, there is increasing recogniti ... Full text Link to item Cite

Pharmacodynamics of Meropenem and Tobramycin for Neonatal Meningoencephalitis: Novel Approaches to Facilitate the Development of New Agents to Address the Challenge of Antimicrobial Resistance.

Journal Article Antimicrob Agents Chemother · April 19, 2022 Neonatal sepsis is an underrecognized burden on health care systems throughout the world. Antimicrobial drug resistance (AMR) is increasingly prevalent and compromises the use of currently recommended first-line agents. The development of new antimicrobial ... Full text 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

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

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

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

Fluid overload in children with pediatric acute respiratory distress syndrome: A retrospective cohort study.

Journal Article Pediatr Pulmonol · January 2022 OBJECTIVES: To assess the association of cumulative fluid overload (FO) up to 14 days from the diagnosis of pediatric acute respiratory syndrome (PARDS) with pediatric intensive care unit (PICU) mortality, 28-day mechanical ventilation free days (VFD), and ... 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

Hydroxychloroquine PK and exposure-response in pregnancies with lupus: the importance of adherence for neonatal outcomes.

Journal Article Lupus Sci Med · January 2022 OBJECTIVE: Evaluate the impact of pregnancy physiology and medication non-adherence on serum hydroxychloroquine (HCQ) pharmacokinetics (PK) and exposure-response in SLE. METHODS: We conducted a PK analysis using data from two observational pregnancy regist ... Full text Link to item Cite

A systematic review of the evidence supporting post-operative antithrombotic use following cardiopulmonary bypass in children with CHD.

Journal Article Cardiol Young · January 2022 OBJECTIVES: To determine the optimal antithrombotic agent choice, timing of initiation, dosing and duration of therapy for paediatric patients undergoing cardiac surgery with cardiopulmonary bypass. METHODS: We used PubMed and EMBASE to systematically revi ... Full text Link to item Cite

Contemporary Trends in Global Mortality of Sepsis Among Young Infants Less Than 90 Days: A Systematic Review and Meta-Analysis.

Journal Article Front Pediatr · 2022 OBJECTIVE: Current knowledge on the global burden of infant sepsis is limited to population-level data. We aimed to summarize global case fatality rates (CFRs) of young infants with sepsis, stratified by gross national income (GNI) status and patient-level ... Full text Link to item Cite

At-home testing to mitigate community transmission of SARS-CoV-2: protocol for a public health intervention with a nested prospective cohort study.

Journal Article BMC Public Health · December 4, 2021 BACKGROUND: The COVID-19 pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to evolve as a global health crisis. Although highly effective vaccines have been developed, non-pharmaceutical interventions remain crit ... Full text Link to item Cite

Impact of Personal Protective Equipment on the Performance of Emergency Pediatric Tasks.

Journal Article Pediatr Emerg Care · December 1, 2021 OBJECTIVES: Personal protective equipment (PPE) is worn by health care providers (HCPs) to protect against hazardous exposures. Studies of HCPs performing critical resuscitation tasks in PPE have yielded mixed results and have not evaluated performance in ... Full text Link to item Cite

Survival, Morbidities, and Developmental Outcomes among Low Birth Weight Infants with Congenital Heart Defects.

Journal Article Am J Perinatol · November 2021 OBJECTIVE: Prematurity and low birth weight (LBW) are risk factors for increased morbidity and mortality in infants with congenital heart defects (CHDs). We sought to describe survival, inhospital morbidities, and 2-year neurodevelopmental follow-up in LBW ... Full text Link to item Cite

Comparative efficacy and safety of late surfactant preparations: a retrospective study.

Journal Article J Perinatol · November 2021 OBJECTIVE: Characterize the use, efficacy, and safety of poractant alfa and calfactant surfactants compared to beractant in preterm infants receiving late surfactant. STUDY DESIGN: We included infants <37 weeks gestational age (GA) discharged from Pediatri ... Full text 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

Pharmacokinetics of Ceftazidime in Children and Adolescents with Obesity.

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

Limited utility of repeated vital sign monitoring during initiation of oral propranolol for complicated infantile hemangioma.

Journal Article J Am Acad Dermatol · August 2021 BACKGROUND: Initial propranolol recommendations for infantile hemangioma published in 2013 were intended as provisional best practices to be updated as evidence-based data emerged. METHODS: A retrospective multicenter study was performed to evaluate utilit ... Full text Link to item Cite

External Evaluation of Two Pediatric Population Pharmacokinetics Models of Oral Trimethoprim and Sulfamethoxazole.

Journal Article Antimicrob Agents Chemother · June 17, 2021 The antibiotic combination trimethoprim (TMP)-sulfamethoxazole (SMX) has a broad spectrum of activity and is used for the treatment of numerous infections, but pediatric pharmacokinetic (PK) data are limited. We previously published population PK (popPK) m ... 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

A systematic review of the evidence supporting post-operative medication use in congenital heart disease.

Journal Article Cardiol Young · May 2021 BACKGROUND: Targeted drug development efforts in patients with CHD are needed to standardise care, improve outcomes, and limit adverse events in the post-operative period. To identify major gaps in knowledge that can be addressed by drug development effort ... Full text Link to item Cite

Delivering clinical trials at home: protocol, design and implementation of a direct-to-family paediatric lupus trial.

Journal Article Lupus Sci Med · May 2021 INTRODUCTION: Direct-to-family clinical trials efficiently provide data while reducing the participation burden for children and their families. Although these trials can offer significant advantages over traditional clinical trials, the process of designi ... Full text Link to item Cite

A systematic review of the evidence supporting post-operative diuretic use following cardiopulmonary bypass in children with Congenital Heart Disease.

Journal Article Cardiol Young · May 2021 BACKGROUND: Paediatric cardiac surgery on cardiopulmonary bypass induces substantial physiologic changes that contribute to post-operative morbidity and mortality. Fluid overload and oedema are prevalent complications, routinely treated with diuretics. The ... Full text Link to item Cite

Pharmacokinetics of Hydrochlorothiazide in Children: A Potential Surrogate for Renal Secretion Maturation.

Journal Article J Clin Pharmacol · March 2021 Hydrochlorothiazide (HCTZ) is a thiazide diuretic used in adults and children for the treatment of hypertension and edema. The pharmacokinetic (PK) properties of HCTZ in children are not well characterized, particularly among children with obesity who freq ... Full text Link to item Cite

Estimation of Body Fat Percentage for Clinical Pharmacokinetic Studies in Children.

Journal Article Clin Transl Sci · March 2021 Obesity is a prevalent childhood condition and the degree of adiposity appears likely to be an important covariate in the pharmacokinetics (PKs) of many drugs. We undertook these studies to facilitate the evaluation and, where appropriate, quantification o ... Full text Link to item Cite

Population pharmacokinetics of olanzapine in children.

Journal Article Br J Clin Pharmacol · February 2021 AIMS: The aim of this study was to evaluate the population pharmacokinetics (PopPK) of olanzapine in children and devise a model-informed paediatric dosing scheme. METHODS: The PopPK of olanzapine was characterized using opportunistically collected plasma ... Full text Link to item Cite

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

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

Translational Drug Development for Pediatric CNS Disorders

Conference NEUROPSYCHOPHARMACOLOGY · 2021 Cite

Safety of sildenafil in premature infants with severe bronchopulmonary dysplasia (SILDI-SAFE): a multicenter, randomized, placebo-controlled, sequential dose-escalating, double-masked, safety study.

Journal Article BMC Pediatr · December 14, 2020 BACKGROUND: Pulmonary hypertension is a deadly complication of bronchopulmonary dysplasia, the most common pulmonary morbidity of prematurity. Despite these catastrophic consequences, no evidence-based therapies are available for the prevention of pulmonar ... Full text Open Access Link to item Cite

An evidence-based review of the use of vasoactive and inotropic medications in post-operative paediatric patients after cardiac surgery with cardiopulmonary bypass from 2000 to 2020.

Journal Article Cardiol Young · December 2020 BACKGROUND: Infants with moderate-to-severe CHD frequently undergo cardiopulmonary bypass surgery in childhood. Morbidity and mortality are highest in those who develop post-operative low cardiac output syndrome. Vasoactive and inotropic medications are ma ... Full text Link to item Cite

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

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

Dead Space to Tidal Volume Ratio Is Associated With Higher Postextubation Support in Children.

Journal Article Respir Care · November 2020 BACKGROUND: Extubation failure is associated with increased duration of mechanical ventilation, length of hospital stay, and mortality. An elevated dead-space-to-tidal-volume ratio (VD/VT) has been proposed as a predictor of successful extubation in childr ... Full text Link to item Cite

Dr. Balevic, et al reply.

Journal Article J Rheumatol · October 1, 2020 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

A Randomized, Controlled Pharmacokinetic and Pharmacodynamics Trial of Ambrisentan After Fontan Surgery.

Journal Article Pediatr Crit Care Med · September 2020 OBJECTIVES: To determine the pharmacokinetics, pharmacodynamics, and safety of the hepatically metabolized endothelin receptor antagonist, ambrisentan in children after Fontan surgery. DESIGN: Prospective, randomized, double-blind, placebo-controlled pharm ... Full text Link to item Cite

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

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

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

Overcoming underpowering: Trial simulations and a global rank end point to optimize clinical trials in children with heart disease.

Journal Article Am Heart J · August 2020 BACKGROUND: Randomized controlled trials (RCTs) in children with heart disease are challenging and therefore infrequently performed. We sought to improve feasibility of perioperative RCTs for this patient cohort using data from a large, multicenter clinica ... Full text Link to item Cite

Contemporary trends in global mortality of sepsis among young infants less than 90 days old: protocol for a systematic review and meta-analysis.

Journal Article BMJ Open · July 31, 2020 INTRODUCTION: Neonatal sepsis has a high mortality rate that varies across different populations. We aim to perform a contemporary global evidence synthesis to determine the case fatality rates of neonatal sepsis, in order to better delineate this public h ... Full text Link to item Cite

Efficacy of Nitric Oxide Administration During Neonatal Cardiopulmonary Bypass.

Journal Article World J Pediatr Congenit Heart Surg · July 2020 This editorial accompanies an original research article by Dr Elzein and colleagues describing findings of a randomized, placebo-controlled trial of nitric oxide administration during cardiopulmonary bypass surgery in infants undergoing the Norwood procedu ... Full text Link to item Cite

Neurocognitive impairment after neonatal sepsis: protocol for a systematic review and meta-analysis.

Journal Article BMJ Open · June 11, 2020 INTRODUCTION: The effect of neonatal sepsis on the developing brain is not well documented. We aim to perform evidence synthesis to determine the outcome of neurodevelopmental impairment and intellectual disability among survivors of neonatal sepsis. The d ... Full text Link to item Cite

Use of normalized prediction distribution errors for assessing population physiologically-based pharmacokinetic model adequacy.

Journal Article J Pharmacokinet Pharmacodyn · June 2020 Currently employed methods for qualifying population physiologically-based pharmacokinetic (Pop-PBPK) model predictions of continuous outcomes (e.g., concentration-time data) fail to account for within-subject correlations and the presence of residual erro ... Full text Link to item Cite

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

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

Hydroxychloroquine in Patients with Rheumatic Disease Complicated by COVID-19: Clarifying Target Exposures and the Need for Clinical Trials.

Journal Article J Rheumatol · May 11, 2020 OBJECTIVE: To characterize hydroxychloroquine (HCQ) exposure in patients with rheumatic disease receiving longterm HCQ compared to target concentrations with reported antiviral activity against the coronavirus disease 2019 caused by SARS-CoV-2 (COVID-19). ... Full text Link to item Cite

Dosing of Continuous Fentanyl Infusions in Obese Children: A Population Pharmacokinetic Analysis.

Journal Article J Clin Pharmacol · May 2020 Differences in fentanyl pharmacokinetics (PK) between obese and nonobese adults have previously been reported; however, the impact of childhood obesity on fentanyl PK is relatively unknown. We developed a population pharmacokinetic (PopPK) model using oppo ... Full text Link to item Cite

Correlation Among Antifactor Xa, Activated Partial Thromboplastin Time, and Heparin Dose and Association with Pediatric Extracorporeal Membrane Oxygenation Complications.

Journal Article ASAIO J · March 2020 Anticoagulation is essential during extracorporeal membrane oxygenation (ECMO) to prevent catastrophic circuit clotting. Several assays exist to monitor unfractionated heparin (UFH), the most commonly used anticoagulant during ECMO, but no single test or c ... Full text Link to item Cite

Pulmonary Valve Endocarditis: The Potential Utility of Multimodal Imaging Prior to Surgery.

Journal Article World J Pediatr Congenit Heart Surg · March 2020 BACKGROUND: The presence of echocardiographic (echo) evidence is a major criterion for the diagnosis of infective endocarditis (IE) by modified Duke criteria. Pulmonary valve (PV) IE, however, can be challenging to identify by echo. We sought to evaluate t ... Full text Link to item Cite

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

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

Rationale and design of the STeroids to REduce Systemic inflammation after infant heart Surgery (STRESS) trial.

Journal Article Am Heart J · February 2020 For decades, physicians have administered corticosteroids in the perioperative period to infants undergoing heart surgery with cardiopulmonary bypass (CPB) to reduce the postoperative systemic inflammatory response to CPB. Some question this practice becau ... Full text Link to item Cite

A phase 1 study of gene therapy with ACTUS-101 in late-onset Pompe disease

Conference Molecular Genetics and Metabolism · February 2020 Full text Cite

Association between preoperative respiratory support and outcomes in paediatric cardiac surgery.

Journal Article Cardiol Young · January 2020 BACKGROUND: Preoperative mechanical ventilation is associated with morbidity and mortality following CHD surgery, but prior studies lack a comprehensive analysis of how preoperative respiratory support mode and timing affects outcomes. METHODS: We retrospe ... Full text Open Access Link to item Cite

PHARMACOEPIDEMIOLOGY OF FUROSEMIDE IN INFANTS

Conference CRITICAL CARE MEDICINE · 2020 Cite

Pharmacokinetics Alterations in Critically Ill Pediatric Patients on Extracorporeal Membrane Oxygenation: A Systematic Review.

Journal Article Front Pediatr · 2020 Objectives: This study aimed to identify alterations in pharmacokinetics in children on extracorporeal membrane oxygenation (ECMO), identify knowledge gaps, and inform future pharmacology studies. Data Sources: We systematically searched the databases MEDL ... Full text Open Access 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

Sedative and Analgesic Pharmacokinetics During Pediatric ECMO.

Journal Article J Pediatr Pharmacol Ther · 2020 Sedatives and analgesics are often administered to critically ill children supported by extracorporeal membrane oxygenation (ECMO) to facilitate comfort and to decrease risks of life-threatening complications. Optimization of sedative and analgesic dosing ... Full text Link to item Cite

Evaluation of Heparin Anti-Factor Xa Levels Following Antithrombin Supplementation in Pediatric Patients Supported With Extracorporeal Membrane Oxygenation.

Journal Article J Pediatr Pharmacol Ther · 2020 OBJECTIVE: Thrombotic events are potential complications in patients receiving extracorporeal membrane oxygenation (ECMO) necessitating the use of systemic anticoagulation with heparin. Heparin works by potentiating the effects of antithrombin (AT), which ... Full text Link to item Cite

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

Journal Article J Clin Pharmacol · December 2019 Milrinone is a type 3 phosphodiesterase inhibitor used to improve cardiac output in critically ill infants and children. Milrinone is primarily excreted unchanged in the urine, raising concerns for toxic accumulation in the setting of renal dysfunction of ... Full text Link to item Cite

A Dried Blood Spot Analysis for Solithromycin in Adolescents, Children, and Infants: A Short Communication.

Journal Article Ther Drug Monit · December 2019 BACKGROUND: Solithromycin is a fourth-generation macrolide antibiotic with potential efficacy in pediatric community-acquired bacterial pneumonia. Pharmacokinetic (PK) studies of solithromycin in pediatric subjects are limited, therefore application of min ... Full text Link to item Cite

Population pharmacokinetics of sildenafil in extremely premature infants.

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

Population Pharmacokinetic/Pharmacodynamic Modeling of Methylprednisolone in Neonates Undergoing Cardiopulmonary Bypass.

Journal Article CPT Pharmacometrics Syst Pharmacol · December 2019 Methylprednisolone is used in neonates to modulate cardiopulmonary bypass (CPB)-induced inflammation, but optimal dosing and exposure are unknown. We used plasma methylprednisolone and interleukin (IL)-6 and IL-10 concentrations from neonates enrolled in a ... 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

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

Population Pharmacokinetics of Doxycycline in Children.

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

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

Electromechanical Dyssynchrony and Clinically Silent Ventricular Dysfunction in Young Subjects with Ventricular Pacing for Congenital and Early Acquired Av Block

Journal Article Biomedical Journal of Scientific & Technical Research · August 2019 ASingle site ventricular pacing can result in electromechanical dyssynchrony and LV dysfunction. A classic pattern by strain echocardiography pattern analysis has been defined that specifically identifies electromechanical dyssynchrony. ... 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

Physiologically Based Pharmacokinetic Modeling for Trimethoprim and Sulfamethoxazole in Children.

Journal Article Clin Pharmacokinet · July 2019 OBJECTIVE: The aims of this study were to (1) determine whether opportunistically collected data can be used to develop physiologically based pharmacokinetic (PBPK) models in pediatric patients; and (2) characterize age-related maturational changes in drug ... 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

Pitfalls of using numerical predictive checks for population physiologically-based pharmacokinetic model evaluation.

Journal Article J Pharmacokinet Pharmacodyn · June 2019 Comparisons between observed data and model simulations represent a critical component for establishing confidence in population physiologically-based pharmacokinetic (Pop-PBPK) models. Numerical predictive checks (NPC) that assess the proportion of observ ... Full text Link to item Cite

Postoperative Transcatheter Interventions in Children Undergoing Congenital Heart Surgery.

Journal Article Circ Cardiovasc Interv · June 2019 Background Postoperative transcatheter interventions (TCIs) are performed after congenital heart surgery to treat residual or recurrent anatomic lesions. We used the Society of Thoracic Surgeons Congenital Heart Surgery Database to evaluate rates of postop ... 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

Commentary: Singling out single ventricles after Fontan.

Journal Article J Thorac Cardiovasc Surg · May 2019 Full text Link to item Cite

How to Conduct Clinical Trials in Children: A Tutorial.

Journal Article Clin Transl Sci · May 2019 Despite a growing interest in, and commitment to, implementing pediatric clinical trials, approximately one in every five trials in children fails because of inappropriate study design, suboptimal experiment planning, or inadequate participant enrollment. ... 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

Correction to: Recurrence of nephrotic syndrome following kidney transplantation is associated with initial native kidney biopsy findings : A Midwest Pediatric Nephrology Consortium (MWPNC) study.

Journal Article Pediatr Nephrol · March 2019 The original version of this article unfortunately contained a mistake. The subtitle "A Midwest Pediatric Nephrology Consortium (MWPNC) study" was missing. The correct title including subtitle is given above. ... Full text Link to item Cite

Creation of a Multicenter Pediatric Inpatient Data Repository Derived from Electronic Health Records.

Journal Article Appl Clin Inform · March 2019 BACKGROUND: Integration of electronic health records (EHRs) data across sites and access to that data remain limited. OBJECTIVE: We developed an EHR-based pediatric inpatient repository using nine U.S. centers from the National Institute of Child Health an ... 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

Agreement of an echocardiogram-based diagnosis of pulmonary hypertension in infants at risk for bronchopulmonary dysplasia among masked reviewers.

Journal Article J Perinatol · February 2019 OBJECTIVE: To evaluate the agreement of an echocardiogram-based pulmonary hypertension diagnosis in premature infants at risk for bronchopulmonary dysplasia (BPD). STUDY DESIGN: Echocardiograms from infants born ≤28 weeks post menstrual age were retrospect ... Full text Link to item Cite

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

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

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

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

Correlation between Regional Cerebral Saturation and Invasive Cardiac Index Monitoring after Heart Transplantation Surgery.

Journal Article J Pediatr Intensive Care · December 2018 The present study assessed the correlations between cerebral regional saturation detected by near infrared spectroscopy (NIRS) and cardiac index (CI) measured by pulmonary artery catheter. This was a retrospective cohort study conducted in the cardiac inte ... Full text Link to item Cite

Improving maternal-infant bonding after prenatal diagnosis of CHD.

Journal Article Cardiol Young · November 2018 BACKGROUND: Infants with prenatally diagnosed CHD are at high risk for adverse outcomes owing to multiple physiologic and psychosocial factors. Lack of immediate physical postnatal contact because of rapid initiation of medical therapy impairs maternal-inf ... 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

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

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

Recurrence of nephrotic syndrome following kidney transplantation is associated with initial native kidney biopsy findings.

Journal Article Pediatr Nephrol · October 2018 BACKGROUND AND OBJECTIVES: Steroid-resistant nephrotic syndrome (SRNS) due to focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) is a leading cause of end-stage kidney disease in children. Recurrence of primary disease following tra ... Full text Link to item Cite

Correction of Biochemical Abnormalities and Improved Muscle Function in a Phase I/II Clinical Trial of Clenbuterol in Pompe Disease.

Journal Article Mol Ther · September 5, 2018 This 52-week, phase I/II double-blind, randomized, placebo-controlled study investigated the novel use of clenbuterol in late-onset Pompe disease (LOPD) stably treated with ERT. Eleven of thirteen participants completed the study. No serious adverse events ... Full text Link to item Cite

External Evaluation of a Gentamicin Infant Population Pharmacokinetic Model Using Data from a National Electronic Health Record Database.

Journal Article Antimicrob Agents Chemother · September 2018 Gentamicin is a common antibiotic used in neonates and infants. A recently published population pharmacokinetic (PK) model was developed using data from multiple studies, and the objective of our analyses was to evaluate the feasibility of using a national ... Full text Link to item Cite

Clinical pharmacology considerations for children supported with ventricular assist devices.

Journal Article Cardiol Young · September 2018 The ventricular assist device is being increasingly used as a "bridge-to-transplant" option in children with heart failure who have failed medical management. Care for this medically complex population must be optimised, including through concomitant pharm ... Full text Link to item Cite

Population Pharmacokinetics of Intramuscular and Intravenous Ketamine in Children.

Journal Article J Clin Pharmacol · August 2018 Ketamine is an N-methyl D-aspartate receptor antagonist used off-label to facilitate dissociative anesthesia in children undergoing invasive procedures. Available for both intravenous and intramuscular administration, ketamine is commonly used when vascula ... 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

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

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

Performance of the Paediatric Index of Mortality 3 and Paediatric Logistic Organ Dysfunction 2 Scores in Critically Ill Children.

Journal Article Ann Acad Med Singap · August 2018 INTRODUCTION: The Paediatric Index of  Mortality 3 (PIM 3) and Paediatric Logistic Organ Dysfunction 2 (PELOD 2) scores were recently revised. We aimed to assess the performance of these scores in a contemporary cohort of critically ill children. MATERIALS ... Link to item Cite

Correlation between minute carbon dioxide elimination and pulmonary blood flow in single-ventricle patients after stage 1 palliation and 2-ventricle patients with intracardiac shunts: A pilot study.

Journal Article Paediatr Anaesth · July 2018 BACKGROUND: Assessment of pulmonary blood flow and cardiac output is critical in the postoperative management of patients with single-ventricle physiology or 2-ventricle physiology with intracardiac shunting. Currently, such hemodynamic data are only obtai ... Full text Link to item Cite

A pharmacokinetic model for amiodarone in infants developed from an opportunistic sampling trial and published literature data.

Journal Article J Pharmacokinet Pharmacodyn · June 2018 Amiodarone is a first-line antiarrhythmic for life-threatening ventricular fibrillation or ventricular tachycardia in children, yet little is known about its pharmacokinetics (PK) in this population. We developed a population PK (PopPK) model using samples ... Full text Link to item Cite

Improving Pediatric Protein Binding Estimates: An Evaluation of α1-Acid Glycoprotein Maturation in Healthy and Infected Subjects.

Journal Article Clin Pharmacokinet · May 2018 BACKGROUND: Differences in plasma protein levels observed between children and adults can alter the extent of xenobiotic binding in plasma, resulting in divergent patterns of exposure. OBJECTIVE: This study aims to quantify the ontogeny of α1-acid glycopro ... Full text Link to item Cite

Trainees’ perception of education in communication and professionalism across two programs in two countries

Journal Article Proceedings of Singapore Healthcare · March 1, 2018 Background: Different health care systems impact on medical education. Objective: We aim to describe the differences and similarities in the perceptions of pediatric residents on education in professionalism and communication skills across two countries. M ... Full text 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

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

Population Pharmacokinetics of Trimethoprim-Sulfamethoxazole in Infants and Children.

Journal Article Antimicrob Agents Chemother · January 2018 Trimethoprim (TMP)-sulfamethoxazole (SMX) is used to treat various types of infections, including community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) and Pneumocystis jirovecii infections in children. Pharmacokinetic (PK) data for infa ... Full text Link to item Cite

Effects of Methadone on Corrected Q-T Interval Prolongation in Critically Ill Children.

Journal Article J Pediatr Pharmacol Ther · 2018 OBJECTIVES: This study aimed to determine the association between methadone use and corrected Q-T interval (QTc) prolongation in critically ill children. METHODS: A retrospective cohort study of critically ill children receiving methadone at a tertiary car ... Full text Link to item Cite

Cardiovascular physiology for intensivists

Chapter · January 1, 2018 Importance: The goal of the cardiovascular system is to maximize delivery of oxygen to organs and tissues to meet their metabolic demands. Disruption of this normal cardiac function is common in a variety of pediatric disease states that require management ... Full text Cite

The effect of antipyretics on immune response and fever following receipt of inactivated influenza vaccine in young children.

Journal Article Vaccine · December 4, 2017 BACKGROUND: Antipyretics reduce fever following childhood vaccinations; after inactivated influenza vaccine (IIV) they might ameliorate fever and thereby decrease febrile seizure risk, but also possibly blunt the immune response. We assessed the effect of ... Full text Link to item Cite

Development of an Adult Physiologically Based Pharmacokinetic Model of Solithromycin in Plasma and Epithelial Lining Fluid.

Journal Article CPT Pharmacometrics Syst Pharmacol · December 2017 Solithromycin is a fluoroketolide antibiotic under investigation for community-acquired bacterial pneumonia (CABP). We developed a whole-body physiologically based pharmacokinetic (PBPK) model for solithromycin in adults using PK-Sim and MoBi version 6.2, ... 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

Development of a Pediatric Physiologically-Based Pharmacokinetic Model of Clindamycin Using Opportunistic Pharmacokinetic Data.

Journal Article Clin Pharmacokinet · November 2017 Physiologically-based pharmacokinetic (PBPK) modeling is a powerful tool used to characterize maturational changes in drug disposition to inform dosing across childhood; however, its use is limited in pediatric drug development. Access to pediatric pharmac ... 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

The Use of Echocardiography for Pediatric Patients Presenting with Syncope.

Journal Article J Pediatr · November 2017 OBJECTIVES: To assess the frequency, yield, and cost of echocardiograms meeting "rarely appropriate" criteria. STUDY DESIGN: Retrospective, single-center study of pediatric patients presenting with syncope. Patients were categorized according to the approp ... Full text Link to item Cite

Drinking Water to Prevent Postvaccination Presyncope in Adolescents: A Randomized Trial.

Journal Article Pediatrics · November 2017 BACKGROUND AND OBJECTIVES: Postvaccination syncope can cause injury. Drinking water prephlebotomy increases peripheral vascular tone, decreasing risk of blood-donation presyncope and syncope. This study evaluated whether drinking water prevaccination reduc ... 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

The Society of Thoracic Surgeons Congenital Heart Surgery Database: 2017 Update on Research.

Journal Article Ann Thorac Surg · September 2017 The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS CHSD) is the largest congenital and pediatric cardiac surgical clinical data registry in the world. It contains data pertaining to more than 435,000 total operations. The most recent b ... Full text Link to item Cite

Effect of Obesity and Underweight Status on Perioperative Outcomes of Congenital Heart Operations in Children, Adolescents, and Young Adults: An Analysis of Data From the Society of Thoracic Surgeons Database.

Journal Article Circulation · August 22, 2017 BACKGROUND: Extreme body mass index (BMI; either very high or very low) has been associated with increased risk of adverse perioperative outcome in adults undergoing cardiac surgery. The effect of BMI on perioperative outcomes in congenital heart disease p ... 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

Evaluating Appropriate Use of Pediatric Echocardiograms for Chest Pain in Outpatient Clinics.

Journal Article J Am Soc Echocardiogr · July 2017 BACKGROUND: Echocardiography is often used in the evaluation of pediatric chest pain, but the incidence of cardiac pathology is low. In 2014, the American College of Cardiology published appropriate use criteria (AUC) for echocardiography including recomme ... 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

Comparison of right ventricle-pulmonary artery shunt position in the Single Ventricle Reconstruction trial.

Journal Article J Thorac Cardiovasc Surg · June 2017 OBJECTIVE: Placement of a right ventricle-pulmonary artery shunt to the left or right of the neoaorta may influence reinterventions, pulmonary artery development, and survival after the Norwood procedure because of differences in shunt and pulmonary artery ... 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

Congenital Heart Disease in Premature Infants 25-32 Weeks' Gestational Age.

Journal Article J Pediatr · February 2017 OBJECTIVE: To determine the birth prevalence of congenital heart defects (CHDs) across the spectrum of common defects in very/extremely premature infants and to compare mortality rates between premature infants with and without CHDs. STUDY DESIGN: The Kids ... 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

Respiratory syncytial virus hospitalisation trends in children with haemodynamically significant heart disease, 1997-2012.

Journal Article Cardiol Young · January 2017 OBJECTIVE: The aim of the study was to evaluate the trends in respiratory syncytial virus-related hospitalisations and associated outcomes in children with haemodynamically significant heart disease in the United States of America. Study design The Kids' I ... 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

Clinical Pharmacology Studies in Critically Ill Children.

Journal Article Pharm Res · January 2017 Developmental and physiological changes in children contribute to variation in drug disposition with age. Additionally, critically ill children suffer from various life-threatening conditions that can lead to pathophysiological alterations that further aff ... 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

Deadspace To Tidal Volume Ratio As A Predictor Of Extubation Success

Conference AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE · January 1, 2017 Link to item Cite

Use of Therapeutic Drug Monitoring, Electronic Health Record Data, and Pharmacokinetic Modeling to Determine the Therapeutic Index of Phenytoin and Lamotrigine.

Journal Article Ther Drug Monit · December 2016 BACKGROUND: Defining a drug's therapeutic index (TI) is important for patient safety and regulating the development of generic drugs. For many drugs, the TI is unknown. A systematic approach was developed to characterize the TI of a drug using therapeutic ... Full text Link to item Cite

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

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

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

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

Continuous High-Frequency Oscillation Therapy in Invasively Ventilated Pediatric Subjects in the Critical Care Setting.

Journal Article Respir Care · November 2016 BACKGROUND: Continuous high-frequency oscillation (CHFO) creates a pressure gradient in the small airways that accelerates expiratory flow. The intended use of CHFO therapy is to facilitate secretion removal and treat atelectasis. Our objective was to asse ... Full text Link to item Cite

Delayed Sternal Closure in Infant Heart Surgery-The Importance of Where and When: An Analysis of the STS Congenital Heart Surgery Database.

Journal Article Ann Thorac Surg · November 2016 BACKGROUND: Delayed sternal closure (DSC) is commonly used to optimize hemodynamic stability after neonatal and infant heart surgery. We hypothesized that duration of sternum left open (SLO) was associated with rate of infection complications, and that loc ... Full text Link to item Cite

Therapeutic Drug Monitoring, Electronic Health Records, and Pharmacokinetic Modeling to Evaluate Sirolimus Drug Exposure-Response Relationships in Renal Transplant Patients.

Journal Article Ther Drug Monit · October 2016 BACKGROUND: Sirolimus, an immunosuppressive agent used in renal transplantation, can prevent allograft rejection. Identification of the therapeutic index (the ratio of minimum toxic concentration to minimum therapeutic concentration) for immunosuppresants ... 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

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

The Society of Thoracic Surgeons Congenital Heart Surgery Database: 2016 Update on Research.

Journal Article Ann Thorac Surg · September 2016 The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS CHSD) is the largest congenital and pediatric cardiac surgical clinical data registry in the world. With more than 400,000 total operations from nearly all centers performing pediatric ... Full text Link to item Cite

Maladaptive aortic properties after the Norwood procedure: An angiographic analysis of the Pediatric Heart Network Single Ventricle Reconstruction Trial.

Journal Article J Thorac Cardiovasc Surg · August 2016 OBJECTIVES: Aortic arch reconstruction in children with single ventricle lesions may predispose to circulatory inefficiency and maladaptive physiology leading to increased myocardial workload. We sought to describe neoaortic anatomy and physiology, risk fa ... 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

Pulmonary Edema and Hypoxic Respiratory Failure.

Journal Article Pediatr Crit Care Med · August 2016 OBJECTIVES: The purpose of this chapter is to outline the causes, physiology, pathophysiology, and management strategies for hydrostatic and permeability pulmonary edema and hypoxic respiratory failure. DATA SOURCE: MEDLINE and PubMed. CONCLUSION: The pulm ... Full text Link to item Cite

Clinicians' Adherence to Guidelines on Evaluation of Hypertension in Children and Adolescents.

Journal Article World J Pediatr Congenit Heart Surg · July 2016 BACKGROUND: Hypertension is increasingly prevalent among children. We sought to review provider adherence to the National High Blood Pressure Education Program (NHBPEP) recommendations at a single academic medical center. METHODS: We identified children 3- ... Full text Link to item Cite

Developing a Tool to Assess Placement of Central Venous Catheters in Pediatrics Patients.

Journal Article J Grad Med Educ · July 2016 BACKGROUND: Pediatric critical care medicine requires the acquisition of procedural skills, but to date no criteria exist for assessing trainee competence in central venous catheter (CVC) insertion. OBJECTIVE: The goal of this study was to create and demon ... 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

Tracheostomy After Operations for Congenital Heart Disease: An Analysis of the Society of Thoracic Surgeons Congenital Heart Surgery Database.

Journal Article Ann Thorac Surg · June 2016 BACKGROUND: Information concerning tracheostomy after operations for congenital heart disease has come primarily from single-center reports. We aimed to describe the epidemiology and outcomes associated with postoperative tracheostomy in a multi-institutio ... 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

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

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

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

Differences in Eccentricity Index and Systolic-Diastolic Ratio in Extremely Low-Birth-Weight Infants with Bronchopulmonary Dysplasia at Risk of Pulmonary Hypertension.

Journal Article Am J Perinatol · January 2016 OBJECTIVE: To compare the left ventricular eccentricity index (EI) and tricuspid valve systolic-diastolic (SD) ratio in infants at risk of bronchopulmonary dysplasia (BPD) and pulmonary hypertension (PH). STUDY DESIGN: Review of echocardiograms performed o ... Full text Link to item Cite

Therapeutic Index Estimation of Antiepileptic Drugs: A Systematic Literature Review Approach.

Journal Article Clin Neuropharmacol · 2016 OBJECTIVES: Our study aimed to determine whether data obtained from the medical literature can be used to estimate the therapeutic index of 5 antiepileptic drugs (AEDs): carbamazepine, lamotrigine, phenobarbital, phenytoin, and valproate. METHODS: We perfo ... Full text Link to item Cite

Effect Of Anti-Factor Xa And Aptt Levels On Mortality In Pediatric Extracorporeal Membrane Oxygenation

Conference AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE · January 1, 2016 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

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

Comparison of invasive and non-invasive pressure gradients in aortic arch obstruction.

Journal Article Cardiol Young · October 2015 BACKGROUND: Aortic arch obstruction can be evaluated by catheter peak-to-peak gradient or by Doppler peak instantaneous pressure gradient. Previous studies have shown moderate correlation in discrete coarctation, but few have assessed correlation in patien ... 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

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

Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database.

Conference Cardiol Young · August 2015 Recent regulatory initiatives in the United States of America and Europe have transformed the paediatric clinical trials landscape by significantly increasing capital investment and paediatric trial volume. The purpose of this manuscript was to review the ... Full text Link to item Cite

Management Practice and Mortality for Infants with Congenital Diaphragmatic Hernia.

Journal Article Am J Perinatol · July 2015 OBJECTIVE: Congenital diaphragmatic hernia (CDH) is fatal in 20 to 40% of cases, largely due to pulmonary dysmaturity, lung hypoplasia, and persistent pulmonary hypertension. Evidence for survival benefit of inhaled nitric oxide (iNO), extracorporeal membr ... 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

Adverse cardiac events in children with Williams syndrome undergoing cardiovascular surgery: An analysis of the Society of Thoracic Surgeons Congenital Heart Surgery Database.

Journal Article J Thorac Cardiovasc Surg · June 2015 OBJECTIVE: Patients with Williams syndrome (WS) undergoing cardiac surgery are at risk for major adverse cardiac events (MACE). Prevalence and risk factors for such events have not been well described. We sought to define frequency and risk of MACE in pati ... 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

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

The influence of angle of insonation and target depth on speckle-tracking strain.

Journal Article J Am Soc Echocardiogr · May 2015 BACKGROUND: Speckle-tracking strain is almost universally cited as being independent of angle of insonation, but there are minimal confirmatory studies, and this claim may not be consistent with the known limitations of ultrasound axial and lateral spatial ... 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

Retinopathy of prematurity risk prediction for infants with birth weight less than 1251 grams.

Journal Article J Pediatr · February 2015 OBJECTIVE: To predict retinopathy of prematurity (ROP) exam findings among infants with birth weight <1251 g from 32-40 weeks postmenstrual age (PMA). STUDY DESIGN: Secondary analysis of 3714 eye exams from 1239 infants. RESULTS: The likelihood of developi ... 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

Circuit oxygenator contributes to extracorporeal membrane oxygenation-induced hemolysis.

Journal Article ASAIO J · 2015 Hemolysis can occur as a consequence of extracorporeal membrane oxygenation (ECMO) and is associated with increased mortality and morbidity. Shear stress generated by flow through the circuit and oxygenator is believed to cause ECMO-induced hemolysis. We h ... 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

Professionalism and Communication Education in Pediatric Critical Care Medicine: The Learner Perspective.

Journal Article Acad Pediatr · 2015 OBJECTIVE: Communication and professionalism are often challenging to teach, and the impact of the use of a given approach is not known. We undertook this investigation to establish pediatric critical care medicine (PCCM) trainee perception of education in ... 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

Cardiopulmonary Resuscitation in Hospitalized Infants

Journal Article CIRCULATION · November 25, 2014 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

Medication use in the neonatal intensive care unit.

Journal Article Am J Perinatol · October 2014 OBJECTIVE: The aim of the article is to provide an update on medication use in infants admitted to the neonatal intensive care unit (NICU) in the United States and examine how use has changed over time. STUDY DESIGN: We performed a retrospective review (20 ... Full text Link to item Cite

Clinical course and outcome predictors of critically ill infants with complete DiGeorge anomaly following thymus transplantation.

Journal Article Pediatr Crit Care Med · September 2014 OBJECTIVES: To identify risk factors for PICU admission and mortality of infants with complete DiGeorge anomaly treated with thymus transplantation. We hypothesized that age at transplantation and the presence of congenital heart disease would be risk fact ... Full text Link to item Cite

Classic-pattern dyssynchrony and electrical activation delays in pediatric dilated cardiomyopathy.

Journal Article J Am Soc Echocardiogr · September 2014 BACKGROUND: Progressive heart failure leading to transplantation or death is common in pediatric dilated cardiomyopathy (DCM), and treatment options are limited. Select children with DCM have improved after cardiac resynchronization therapy (CRT), but pred ... 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

Cumulative radiation exposure and cancer risk estimation in children with heart disease.

Journal Article Circulation · July 8, 2014 BACKGROUND: Children with heart disease are frequently exposed to imaging examinations that use ionizing radiation. Although radiation exposure is potentially carcinogenic, there are limited data on cumulative exposure and the associated cancer risk. We ev ... Full text Link to item Cite

Severe acute malnutrition in childhood: hormonal and metabolic status at presentation, response to treatment, and predictors of mortality.

Journal Article J Clin Endocrinol Metab · June 2014 OBJECTIVE: Malnutrition is a major cause of childhood morbidity and mortality. To identify and target those at highest risk, there is a critical need to characterize biomarkers that predict complications prior to and during treatment. METHODS: We used targ ... Full text Link to item Cite

Comprehensive assessment of right ventricular function in patients with pulmonary hypertension with global longitudinal peak systolic strain derived from multiple right ventricular views.

Journal Article J Am Soc Echocardiogr · June 2014 BACKGROUND: Right ventricular (RV) function is a strong predictor of mortality in pulmonary hypertension (PH), but two-dimensional (2D) echocardiography-derived assessments of RV function that could aid in risk assessment and management of patients with PH ... Full text Link to item Cite

Serum brain natriuretic peptide and risk of acute kidney injury after cardiac operations in children.

Journal Article Ann Thorac Surg · June 2014 BACKGROUND: Acute kidney injury (AKI) after pediatric cardiac operations is associated with poor outcomes and is difficult to predict. We conducted a prospective study to evaluate whether preoperative brain natriuretic peptide (BNP) levels predict postoper ... Full text Link to item Cite

Risk of necrotizing enterocolitis in very-low-birth-weight infants with isolated atrial and ventricular septal defects.

Journal Article J Perinatol · April 2014 OBJECTIVE: Necrotizing enterocolitis (NEC) is associated with a significant morbidity and mortality in premature infants. We sought to identify the frequency of NEC in very-low-birth-weight infants with isolated ventricular septal defects (VSDs) or atrial ... 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

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

Survey of clinical infant lung function testing practices.

Journal Article Pediatr Pulmonol · February 2014 BACKGROUND: Data supporting the clinical use of infant lung function (ILF) tests are limited making the interpretation of clinical ILF measures difficult. OBJECTIVES: To evaluate current ILF testing practices and to survey users regarding the indications, ... Full text Link to item Cite

Effects of HIV infection on the metabolic and hormonal status of children with severe acute malnutrition.

Journal Article PLoS One · 2014 BACKGROUND: HIV infection occurs in 30% of children with severe acute malnutrition in sub-Saharan Africa. Effects of HIV on the pathophysiology and recovery from malnutrition are poorly understood. METHODS: We conducted a prospective cohort study of 75 sev ... Full text Link to item Cite

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Conference Critical Care Medicine · December 2013 Full text Cite

339

Conference Critical Care Medicine · December 2013 Full text Cite

Comparative effectiveness of surfactant preparations in premature infants.

Journal Article J Pediatr · October 2013 OBJECTIVE: To compare effectiveness of 3 surfactant preparations (beractant, calfactant, and poractant alfa) in premature infants for preventing 3 outcomes: (1) air leak syndromes; (2) death; and (3) bronchopulmonary dysplasia (BPD) or death (composite out ... Full text Link to item Cite

Intervention for recoarctation in the single ventricle reconstruction trial: incidence, risk, and outcomes.

Journal Article Circulation · August 27, 2013 BACKGROUND: Recoarctation after the Norwood procedure increases risk for mortality. The Single Ventricle Reconstruction (SVR) trial randomized subjects with a single right ventricle undergoing a Norwood procedure to a modified Blalock-Taussig shunt or a ri ... Full text Link to item Cite

Effects of low-dose dopamine on urine output in normotensive very low birth weight neonates.

Journal Article J Perinatol · August 2013 OBJECTIVE: To determine the effects of low-dose dopamine on urine output (UOP) in very low birth weight premature neonates. STUDY DESIGN: Retrospective cohort study of all low-dose (3-5 μg kg(-1) per min) dopamine infusions >24-h duration in neonates 1500 ... 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

Are pediatric critical care medicine fellowships teaching and evaluating communication and professionalism?

Journal Article Pediatr Crit Care Med · June 2013 OBJECTIVES: To describe the teaching and evaluation modalities used by pediatric critical care medicine training programs in the areas of professionalism and communication. DESIGN: Cross-sectional national survey. SETTING: Pediatric critical care medicine ... Full text Link to item Cite

Lateral mass versus hybrid construct for cervical laminectomy and fusion.

Journal Article Orthopedics · April 2013 Spine stabilization after C3-C7 laminectomy can be accomplished with many instrumentation options. A hybrid construct using lateral mass screws from C3 to C5 and pedicle screws at C7 can potentially maximize strength and solve the spatial constraints intro ... Full text Link to item Cite

Urinary tract infection concordance with positive blood and cerebrospinal fluid cultures in the neonatal intensive care unit.

Journal Article J Perinatol · April 2013 OBJECTIVE: Urinary tract infections (UTI) are common in the neonatal intensive care unit (NICU). Blood, urine and cerebrospinal fluid (CSF) cultures are frequently obtained to evaluate for infection. We sought to determine the concordance between positive ... Full text Link to item Cite

Risk factors for invasive candidiasis in infants >1500 g birth weight.

Journal Article Pediatr Infect Dis J · March 2013 BACKGROUND: We describe the incidence, risk factors and outcomes of invasive candidiasis in infants >1500 g birth weight. METHODS: We conducted a retrospective cohort study of infants >1500 g birth weight discharged from 305 neonatal intensive care units i ... Full text Link to item Cite

Group B Streptococcus and Escherichia coli infections in the intensive care nursery in the era of intrapartum antibiotic prophylaxis.

Journal Article Pediatr Infect Dis J · March 2013 BACKGROUND: Group B Streptococcus (GBS) and Escherichia coli cause serious bacterial infections (SBIs) and are associated with morbidity and mortality in newborn infants. Intrapartum antibiotic prophylaxis reduces early-onset SBIs caused by GBS. The effect ... Full text Link to item 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

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 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

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

Relative impact of surgeon and center volume on early mortality after the Norwood operation.

Journal Article Ann Thorac Surg · June 2012 BACKGROUND: Previous studies suggest center volume is associated with outcome after the Norwood operation; however, the impact of surgeon volume is less clear. We evaluated the relative impact of surgeon and center volume on mortality in a large Norwood co ... Full text Link to item Cite

The complex relationship between center volume and outcome in patients undergoing the Norwood operation.

Journal Article Ann Thorac Surg · May 2012 BACKGROUND: Norwood outcomes vary across centers, and a relationship between center volume and outcome has been previously described. It is unclear whether this volume-outcome relationship exists across all levels of patient risk or holds true for all cent ... 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

Complications after the Norwood operation: an analysis of The Society of Thoracic Surgeons Congenital Heart Surgery Database.

Journal Article Ann Thorac Surg · November 2011 BACKGROUND: Limited multicenter data exist regarding the prevalence of postoperative complications after the Norwood operation and their associated mortality risk. METHODS: We evaluated infants in The Society of Thoracic Surgeons Congenital Heart Surgery D ... Full text Link to item Cite

Preoperative diagnosis of long QT syndrome in an infant with tetralogy of Fallot.

Journal Article Pediatr Cardiol · August 2011 Long QT syndrome is a well-described entity in infants. Its presentation in the context of congenital heart disease is rare and is almost exclusively diagnosed postoperatively. For patients undergoing surgical intervention, preoperative knowledge of the di ... Full text Link to item Cite

Successful extracorporeal membrane oxygenation for respiratory failure in an infant with DiGeorge anomaly, following thymus transplantation.

Journal Article Respir Care · June 2011 We report the first successful use of venovenous extracorporeal membrane oxygenation (ECMO) for refractory respiratory failure in an infant with DiGeorge anomaly, following thymus transplantation. A 23-month-old female with complete immune-incompetent DiGe ... 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

PATIENT RISK STATUS, CENTER VOLUME AND OUTCOME FOLLOWING THE NORWOOD OPERATION

Conference Journal of the American College of Cardiology · April 2011 Full text 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

cDermo-1 misexpression induces dense dermis, feathers, and scales.

Journal Article Dev Biol · January 1, 2005 Reciprocal epithelio-mesenchymal interactions between the prospective epidermis and the underlying dermis are the major driving forces in the development of skin appendages. Feather development is initiated by a still unknown signal from the dermis in feat ... Full text Link to item Cite

Twist is an integrator of SHH, FGF, and BMP signaling.

Journal Article Anat Embryol (Berl) · November 2004 Development of vertebrate embryos is regulated by a number of different signaling pathways. These pathways are frequently not independent of each other but are connected by crosstalk between cells and tissues. Furthermore, different signaling pathways have ... Full text Link to item Cite

PI3K/Akt and apoptosis: size matters.

Journal Article Oncogene · December 8, 2003 Recent research has examined Akt and Akt-related serine-threonine kinases in signaling cascades that regulate cell survival and are important in the pathogenesis of degenerative diseases and in cancer. We seek to recapitulate the research that has helped t ... Full text Link to item Cite

The function of cDermo-1 in skin development

Conference EUROPEAN JOURNAL OF CELL BIOLOGY · March 1, 2003 Link to item Cite

BMPs induce dermal markers and ectopic feather tracts.

Journal Article Mech Dev · January 2002 Bone morphogenetic protein (BMP) signaling is known to be involved in multiple inductive events during embryogenesis including the development of amniote skin. Here, we demonstrate that early application of BMP-2 to the lateral trunk of chick embryos induc ... Full text Link to item Cite