Low Etanercept Concentrations in Children With Obesity and Juvenile Idiopathic Arthritis

The Journal of Pediatric Pharmacology and Therapeutics November 2021

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Balevic SJ, Becker ML, Gonzalez D, Funk RS

This study evaluated the impact of obesity on etanercept (ETN) drug exposure in children with juvenile idiopathic arthritis (JIA). The data suggest that children who are obese may be routinely under-dosed using current dosing strategies. As a result, characterizing adequate drug exposure in children of all sizes is an important step toward precision dosing.

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

Journal of Perinatology November 2021

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Lane MD, Kishnani S, Udemadu O, Danquah SE, Treadway RM, Langman A, Balevic S, Jackson WM, Laughon M, Hornik CP, Greenberg RG, Clark RH, Zimmerman KO

This study sought to characterize the use, efficacy, and safety of poractant alfa and calfactant surfactants compared to beractant in preterm infants receiving late surfactant. Compared to beractant, there is no evidence of overall superior efficacy or safety of poractant alfa.

Pharmacokinetics of Ceftazidime in Children and Adolescents with Obesity

Paediatric Drugs  September 2021

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Maharaj AR, Wu H, Zimmerman KO, Muller WJ, Sullivan JE, Sherwin CMT, Autmizguine J, Rathore MH, Hornik CD, Al-Uzri A, Payne EH, Hornik CP, on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee

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.

Physiologically Based Pharmacokinetic (PBPK) Modeling of Meropenem in Preterm and Term Infants

Clinical Pharmacokinetics June 2021

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Ganguly S, Edginton A, Gerhart JG, Cohen-Wolkowiez M, Greenberg RG, Gonzalez D; on behalf of the Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee
This study applied physiologically based pharmacokinetic (PBPK) modeling to characterize the disposition of the antibiotic meropenem in preterm and term infants. Meropenem is approved by the US Food and Drug Administration for use in pediatric patients, including treating complicated intra-abdominal infections in infants < 3 months of age. The PBPK model-based simulations were performed to evaluate meropenem dosing in the product label for infants < 3 months of age treated for complicated intra-abdominal infections. The PBPK model used supports the meropenem dosing regimens recommended in the product label for infants <3 months of age.

Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections

The Pediatric Infectious Disease Journal June 2021

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Smith MJ, Boutzoukas A, Autmizguine J, Hudak M, Zinkhan E, Bloom BT, Heresi G, Lavery A, Courtney S, Sokol GR, Cotton CM, Bliss J, Mendley S, Bendel C, Dammann C, Weitkamp JH, Saxonhouse MA, Mundakel GT, Debski J, Lewandowski A, Erinjeri J, Gao J, Benjamin DK, Hornik C, Smith PB, Cohen-Wolkowiez M, on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network
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 this population. One hundred eighty infants ≤33 weeks gestational age and <121 days postnatal age with cIAI were randomized to ≤10 days of ampicillin, gentamicin, and metronidazole (group 1); ampicillin, gentamicin, and clindamycin (group 2); or piperacillin-tazobactam and gentamicin (group 3). There were no differences in safety outcomes between antibiotic regimens. Each of the antibiotic regimens are safe in premature infants with cIAI.

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

Journal Perinatology April 2021

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Aleem S, Robbins C, Murphy B, Elliott S, Akinyemi C, Paredes N, Tolia VN, Zimmerman KO, Goldberg RN, Benjamin DK, Greenberg RG

This study aimed to characterize the association between hydrocortisone receipt and hospital outcomes of infants with persistent pulmonary hypertension of the newborn (PPHN). There was no association between hydrocortisone receipt and death, CLD, or oxygen at discharge in our cohort. Prospective studies are needed to evaluate the effectiveness of hydrocortisone in infants with PPHN.

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

Journal of Pediatric Intensive Care March 2021

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Zimmerman KO, Spears T, Cobbaert M, Boakye-Agyeman F, Wu H, Cohen-Wolkowiez M, Watt KM, Benjamin DK, Becker ML, Traube C, Smith PB

Adverse drug events are common in critically ill children and often result from systemic or target organ drug exposure. Methods of drug dosing and titration that consider pharmacokinetic alterations may improve our ability to optimally dose critically ill patients and reduce the risk for drug-related adverse events. To demonstrate this possibility, this study explored the exposure-response relationship between midazolam and delirium in critically ill children.

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

North Carolina Medical Journal February 2021

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Boutzoukas AE, Akinboyo IC, Wong CA, Benjamin DK, Zimmerman KO

The COVID-19 pandemic resulted in large-scale school closures in an effort to reduce the spread of disease. This article reviews the potential impact of COVID-19-related school closures on the health of children in North Carolina, with particular attention to the impact of school closures on drivers of child health.

Bringing research directly to families in the era of COVID-19

Pediatric Research November 2020

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Balevic SJ, Singler L, Randell R, Chung RJ, Lemmon ME, Hornik CP

In order to optimize direct-to-family trials, investigators should seek early feedback from regulatory authorities about proposed safety and follow-up procedures, and feedback from family and other stakeholders on study schedules and interventions. Pediatric clinical research must adapt to be more flexible, efficient, and cost effective to increase access to clinical trials both during the COVID-19 pandemic and beyond.

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

Journal of Neonatal-Perinatal Medicine June 2020

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Dallefeld SH, Smith PB, Crenshaw EG, Daniel KR, Gilleskie ML, Smith DS, Balevic S, Greenberg RG, Chu V, Clark R, Kumar KR, Zimmerman KO

Given the limited available evidence on chloral hydrate safety in neonatal populations and the discrepancy in chloral hydrate acceptance between the US and other countries, we sought to clarify the safety profile of chloral hydrate compared to other sedatives in hospitalized infants.