Publications

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

Posted on by Kayla Korzekwinski

Pediatric Emergency Care • December 2021

Adler MD, Krug S, Eiger C, Good GL, Kou M, Nash M, Henretig FM, Hornik CP, Gosnell L, Chen JY, Debski J, Sharma G, Siegel D, Donoghue A

 

This study evaluated the impacts of personal protective equipment (PPE) on timeliness or success of emergency procedures performed by pediatric health care providers (HCPs). For session 1, HCPs wore normal attire; for session 2, they wore full-shroud PPE garb with 2 glove types: Ebola level or chemical. During each session, they performed clinical tasks on a patient simulator: intubation, bag-valve mask ventilation, venous catheter (IV) placement, push-pull fluid bolus, and defibrillation. Personal protective equipment did not affect procedure timeliness or success on a simulated child, with the exception of IV placement. Further study is needed to investigate PPE’s impact on procedures performed in a clinical care context.

 

 

Capacity Building in a New Clinical Trials Network through Inter-Network Collaboration

Posted on by Kayla Korzekwinski

The Journal of Pediatrics • January 2022

Knight L, Pahud BA, Scheffler M, Euteneuer JC, Allen C, Ross J, Ali W, Meyer M, Purohit PJ, Zimmerman KO, Sullivan JE; on behalf of the ECHO IDeA States Pediatric Clinical Trials Network

 

The Institutional Development Award (IDeA) is a congressionally mandated program helping to build research capacity by supporting research, faculty development, and infrastructure improvements in states with low National Institutes of Health (NIH) funding levels. Children, racial, and ethnic minorities, rural populations, and patients of low socioeconomic status are underrepresented in clinical research, which limits the generalizability of results. To address this gap, 17 institutions were awarded funding in 2016 to establish the IDeA States Pediatric Clinical Trials Network (ISPCTN) by the NIH’s Environmental Influences on Child Health Outcomes Program.

 

 

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

Posted on by Kayla Korzekwinski

Journal of Perinatology • January 2022

Jackson W, Gonzalez D, Smith PB, Ambalavanan N, Atz A, Sokol GM, Hornik CD, Stewart D, Mundakel G, Poindexter BB, Ahlfeld SK, Mills M, Cohen-Wolkowiez M, Martz K, Hornik CP, Laughon MM; on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee

 

This study sought to characterize the safety of sildenafil in premature infants. Safety was evaluated based on adverse events (AEs), transaminase levels, and mean arterial pressure monitoring. There was one serious AE related to the study drug involving hypotension associated with a faster infusion rate than specified by the protocol. There were no AEs related to elevated transaminases. Sildenafil was well tolerated by the study population. Drug administration times and flush rates require careful attention to prevent infusion-related hypotension associated with faster infusions of IV sildenafil in premature infants.

 

 

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

Posted on by Kayla Korzekwinski

Clinical Pharmacokinetics • June 2021

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.

 

 

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

Posted on by Kayla Korzekwinski

Antimicrobial Agents and Chemotherapy • June 2021

Wu YSS, Cohen-Wolkowiez M, Hornik CP, Gerhart JG, Autmizguine J, Cobbaert M, Gonzalez D

 

This study tested the pediatric pharmacokinetics (PK) of the antibiotic combination trimethoprim (TMP)-sulfamethoxazole (SMX) that is used to treat a variety of infections. Both models used supported TMP-SMX dose increases in infants and young children for resistant pathogens with a MIC of 1 mg/liter, although the required dose increase based on the external model was lower.

 

 

Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections

Posted on by Kayla Korzekwinski

The Pediatric Infectious Disease Journal • June 2021

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.

 

 

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

Posted on by Kayla Korzekwinski

Contemporary Clinical Trials Communications • May 2021

Corneli A, Perry B, Benjamin DK Jr, Zimmerman KO

 

This study conducted formative research using in-depth interviews to identify preferences for and anticipated responses to receiving thank you notes and lay summaries of aggregate results among caregivers and adolescent participants of pragmatic pediatric studies conducted by the National Institute of Health-sponsored Pediatric Trials Network. Nearly all participants said receiving a thank you note would make them feel valued, appreciated, and proud because they contributed to science. Similarly, nearly all participants said that receiving a summary of research results would make them aware of their role in improving the lives of children, feel like they are an active partner in research, and believe that researchers want to keep them informed.

 

 

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

Posted on by Kayla Korzekwinski

Journal of the Pediatric Infectious Diseases Society • May 2021

Le J, Greenberg RG, Benjamin DK Jr, Yoo Y, Zimmerman KO, Cohen-Wolkowiez M, Wade KC; on behalf of the Administrative Core Committee of the Best Pharmaceuticals for Children Act – Pediatric Trials Network

 

Premature, very low birth weight neonates are at risk for early-onset sepsis and receive ampicillin and gentamicin post-birth. Antimicrobial stewardship supports short-course antibiotics, but how long antibiotic concentrations remain therapeutic post-last dose is unknown. This study used simulations to examine antibiotic exposures in 34,689 neonates. Therapeutic exposure for ampicillin and gentamicin was evaluated relative to the minimum inhibitory concentration for common pathogens. Ampicillin exposure remains therapeutic long after the last dose. Short-course ampicillin provided therapeutic exposures throughout the typical blood culture incubation period.

 

 

Evaluating Site-Level Implementations of the HL7 FHIR Standard to Support eSource Data Exchange in Clinical Research

Posted on by Kayla Korzekwinski

Studies in Health Technology and Informatics • May 2021

Garza MY, Eisenstein E, Kumar KR, Zimmerman KO, Zozus M
Direct extraction and use of electronic health record (EHR) data is a long-term and multifaceted endeavor. A systematic mapping of study data elements was used to measure the coverage of the Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®) standard for a federally sponsored, pragmatic cardiovascular randomized controlled trial (RCT) targeting adults. Researchers evaluated site-level implementations of the HL7® FHIR® standard to investigate study- and site-level differences that could affect coverage and offer insight into the feasibility of a FHIR-based eSource solution for multicenter clinical research.

 

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

Posted on by Kayla Korzekwinski

Pediatrics • May 2021

Abdel-Rahman SM, Paul IM, Hornik C, Sullivan JE, Wade K, Delmore P, Sharma G, Benjamin DK, Zimmerman KO

The Best Pharmaceuticals for Children Act (BPCA) incentivizes the study of on-patent medicines in children and mandates that the NIH sponsor research on off-patent drugs important to pediatric therapeutics. Failing to enroll cohorts that reflect the pediatric population at large restricts the generalizability of such studies. This investigation evaluates racial and ethnic minority representation among participants enrolled in BPCA-sponsored studies. This study revealed no evidence of racial and ethnic bias in enrollment for pediatric studies conducted with funding from BPCA, fulfilling the legislation’s expectation to ensure adequate representation of all children.