Anthropometric data

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

Posted on by Kayla Korzekwinski

Clinical Pharmacokinetics • February 2022

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Gerhart JG, Carreno FO, Edginton AN, Sinha J, Perrin E, Kumar KR, Rikhi A, Hornik CP, Harris V, Ganguly S, Cohen-Wolkowiez M, Gonzalez D; on behalf of the Best Pharmaceuticals for Children Act — Pediatric Trials Network Steering Committee
A virtual population of children with obesity was developed using national survey, electronic health record, and clinical trial data, as well as data extracted from the literature. The objective of this study was to develop a virtual population of children with obesity to enable physiologically based pharmacokinetic modeling, then use the novel virtual population in conjunction with previously developed models of clindamycin and trimethoprim/sulfamethoxazole to better understand dosing of these drugs in children with obesity. Model simulations supported current recommended weight-based dosing in children with obesity for clindamycin and trimethoprim/sulfamethoxazole, as they met target exposure despite these changes in clearance and volume of distribution.

Estimation of Body Fat Percentage for Clinical Pharmacokinetic Studies in Children

Posted on by Kayla Korzekwinski

Clinical and Translational Science • March 2021

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Green TP, Binns HJ, Wu H, Ariza AJ, Perrin EM, Quadri M, Hornik CP, Cohen-Wolkowiez M

Obesity is a prevalent childhood condition and the degree of adiposity is likely to be an important covariate in the pharmacokinetics (PKs) of many drugs. The goal of these studies was to facilitate the evaluation and, where appropriate, quantification of the covariate effect of body fat percentage (BF%) on PK parameters in children. Researchers examined two large databases to determine the values and variabilities of BF% in children with healthy body weights and in those with obesity, comparing the accuracy and precision of BF% estimation by both clinical methods and demographically derived techniques. They also conducted simulation studies to evaluate the utility of the several methods for application in clinical trials. The estimation of BF% from sex and obesity stage can routinely be applied to PK clinical trials to evaluate the contribution of BF% as a potential covariate.

Validation and human factor analysis study of an infant weight estimation device

Posted on by Kayla Korzekwinski

BMC Pediatrics • January 2020

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Abdel-Rahman SM, Paul IM, Delmore P, Chen JY, Mills M, Greenberg RG, on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network

Weight is critical for the medical management of infants; however, scales can be unavailable or inaccessible in some practice settings. We recently developed and validated a robust infant weight estimation method based on chest circumference (CC) and head circumference (HC). Among 486 infants enrolled, predicted weight was within 10 and 15% of actual weight in 86 and 99%, of infants. This device can be used to estimate weight in infants when calibrated scales are impractical or unavailable.

A Weight Estimation Strategy for Preterm and Full-Term Infants

Posted on by Kayla Korzekwinski

Global Pediatric Health • December 2017

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Abdel-Rahman SM, Paul IM, Delmore P, James L, Fearn L, Atz A, Poindexter B, Al-Uzri A, Lewandowski A, Harper B, Smith PB.

Weight is the foremost marker of health outcomes in infants; however, the majority of community workers and health care providers in remote, resource-constrained settings have limited access to functional scales. This study develops and validates a simple weight estimation strategy for infants that addresses the limitations of current approaches.

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

Posted on by Kayla Korzekwinski

Annals of Human Biology • December 2017

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Abdel-Rahman SM, Paul IM, Delmore P, James L, Fearn L, Atz AM, Poindexter BB, Al-Uzri A, Lewandowski A, Harper BL, Smith PB; Best Pharmaceuticals for Children Act – Pediatric Trials Network.

Anthropometric data prove valuable for screening and monitoring various medical conditions. In young infants, however, only weight, length and head circumference are represented in publicly accessible databases. Our aim was to characterise length and circumferential measures in pre-term and full-term infants up to 90 days post-natal.

Pharmacokinetics of Clindamycin in Obese and Nonobese Children

Posted on by Kayla Korzekwinski

Antimicrobial Agents and Chemotherapy • March 2017

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Smith MJ, Gonzalez D, Goldman JL, Yogev R, Sullivan JE, Reed MD, Anand R, Martz K, Berezny K, Benjamin DK Jr, Smith PB, Cohen-Wolkowiez M, Watt K; Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee.

Although obesity is prevalent among children in the United States, pharmacokinetic (PK) data for obese children are limited. Clindamycin is a commonly used antibiotic that may require dose adjustment in obese children due to its lipophilic properties. We performed a clindamycin population PK analysis using data from three separate trials. A total of 420 samples from 220 children, 76 of whom had a body mass index greater than or equal to the 95th percentile for age, were included in the analysis. Compared to other metrics, total body weight (TBW) was the most robust measure of body size.

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

Posted on by Kayla Korzekwinski

JAMA Peds • July 2015

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Harskamp-van Ginkel MW, Hill KD, Becker KC, Testoni D, Cohen-Wolkowiez M, Gonzalez D, Barrett JS, Benjamin DK Jr, Siegel DA, Banks P, Watt KM; Best Pharmaceuticals for Children Act–Pediatric Trials Network Administrative Core Committee.

Obesity affects nearly one-sixth of US children and results in alterations to body composition and physiology that can affect drug disposition, possibly leading to therapeutic failure or toxic side effects. The depth of available literature regarding obesity’s effect on drug safety, pharmacokinetics, and dosing in obese children is unknown.

Pharmacokinetics of Antimicrobials in Obese Children

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GaBI Journal • June 2014

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Sampson M, Cohen-Wolkowiez M, Benjamin D Jr, Capparelli E, Watt K.

Childhood obesity is common and results in substantial morbidity. The most commonly prescribed drugs in obese children are antibiotics. However, physiological changes associated with childhood obesity can alter antibiotic pharmacokinetics and optimal body size measures to guide dosing in this population are ill defined. This combination can result in therapeutic failures or drug-related toxicities. This review summarizes pharmacokinetic information for antibiotics in obese children and implications for dosing.

Evaluation of the Mercy TAPE: performance against the standard for pediatric weight estimation

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Annals of Emergency Medicine • October 2013

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Abdel-Rahman SM, Paul IM, James LP, Lewandowski A; Best Pharmaceuticals for Children Act-Pediatric Trials Network.

We assessed the performance of 2 new devices (2D- and 3D-Mercy TAPE) to implement the Mercy Method for pediatric weight estimation and contrasted their accuracy with the Broselow method. We enrolled children aged 2 months through 16 years in this prospective, multicenter, observational study.