Author: Kayla Korzekwinski

Assessing clinical site readiness for electronic health record (EHR)-to-electronic data capture (EDC) automated data collection

Posted on by Kayla Korzekwinski

Contemporary Clinical Trials • May 2023

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Eisenstein EL, Zozus MN, Garza MY, Lanham HJ, Adagarla B, Walden A, Zimmerman KO, Kumar KR

eSource software is used to automatically copy a patient’s electronic health record data into a clinical study’s electronic case report form. However, there is little evidence to assist sponsors in identifying the best sites for multi-center eSource studies. This site developed an eSource site readiness survey. The survey was administered to principal investigators, clinical research coordinators, and chief research information officers at Pediatric Trial Network sites.

Safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia: Rationale and methods of a phase II randomized trial

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Contemporary Clinical Trials Communications • December 2022

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Lang JE, Hornik CD, Martz K, Jacangelo J, Anand R, Greenberg R, Hornik C, Zimmerman K, Smith PB, Benjamin DK, Laughon M
Bronchopulmonary dysplasia (BPD) is a disease of chronic respiratory insufficiency stemming from premature birth and iatrogenic lung injury leading to many complications. BPD is the most common pulmonary sequela of prematurity and is often fatal; however, there remains no FDA-approved therapies to treat or prevent BPD. Sildenafil is increasingly used off-label in premature infants despite scant safety and efficacy data. We developed the phase II SIL02 trial to describe the safety, pharmacokinetics and preliminary effectiveness of intravenous and enteral sildenafil in premature infants at risk for BPD.
Thumbnail photo of PPE Results-at-a-Glance

PPE Results-at-a-Glance

Posted on by Kayla Korzekwinski

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Personal protective equipment (PPE) is worn by health care providers to protect them from exposure to hazardous materials such as chemicals or infectious diseases. Previous studies examining the effects of PPE on health care providers’ ability to perform emergency tasks have had mixed results. Additionally, there have not been studies evaluating the performance of these tasks on children while wearing PPE. These studies were needed to determine how PPE impacts health care providers’ ability to perform emergency care for pediatric groups.

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

Posted on by Kayla Korzekwinski

Clinical Pharmacology & Therapeutics • August 2022

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Gerhart JG, Carreño FO, Loop MS, Lee CR, Edginton AN, Sinha J, Kumar KR, Kirkpatrick CM, Hornik CP, Gonzalez D; Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee
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 to achieve maximum concentration within a narrow therapeutic or prophylactic target range. However, whether children with and without obesity experience equivalent enoxaparin exposure remains unclear. The study aimed to answer this clinical question. Enoxaparin exposure was better matched across age groups and obesity status using fat-free mass weight-based dosing.

Exposure-safety relationship for acyclovir in the treatment of neonatal herpes simplex virus disease

Posted on by Kayla Korzekwinski

Early Human Development • July 2022

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Ericson J, Benjamin DK Jr., Boakye-Agyeman F, Balevic SJ, Cotten MC, Adler-Shohet F, Laughon M, Poindexter B, Harper B, Payne EH, Kaneshige K, Smith PB; Best Pharmaceuticals for Children Act – Pediatric Trials Network
Neonatal herpes simplex virus (HSV) disease has been treated with high-dose (20 mg/kg/dose) acyclovir since 1991. This study aimed to determine the safety of acyclovir in infants with neonatal HSV treated with high-dose acyclovir and examine the association between acyclovir dose and exposure with adverse events (AEs). The odds of experiencing any clinical or laboratory AE did not differ by predicted acyclovir exposure. Although AEs were common with high-dose acyclovir exposure, severe AEs were rare. Acyclovir exposure was not associated with AEs.

Population Pharmacokinetics of Piperacillin/Tazobactam Across the Adult Lifespan

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Clinical Pharmacokinetics • January 2023

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Hemmersbach-Miller M, Balevic SJ, Winokur PL, Landersdorfer C, Gu K, Chan AW, Cohen-Wolkowiez M, Conrad T, An G, Kirkpatrick C, Swamy GK, Walter EB, Schmader KE

Piperacillin/tazobactam is one of the most frequently used antimicrobials in older adults. Using an opportunistic study design, we evaluated the pharmacokinetics of piperacillin/tazobactam as a probe drug to evaluate changes in antibacterial drug exposure and dosing requirements, including in older adults.

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

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Journal of Clinical Pharmacology • January 2023

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Balevic SJ, Niu J, Chen J, Green D, McMahon A, Hornik CP, Schanberg L, Glaser R, Doddapaneni S, Gonzalez D, Burckart GJ

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 between drug exposure and response for selected drugs in systemic lupus erythematosus (SLE) was sufficiently similar to support a consideration of the extrapolation of adult efficacy data to children of ≥5 years of age.

Methylprednisolone for Heart Surgery in Infants – A Randomized, Controlled Trial

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The New England Journal of Medicine • December 2022

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Hill KD, Kannankeril PJ, Jacobs JP, Baldwin HS, Jacobs ML, O’Brien SM, Bichel DP, Graham EM, Blasiole B, Resheidat A, Husain AS, Kumar SR, Kirchner JL, Gallup DS, Turek JW, Bleiweis M, Mettler B, Benscoter A, Wald E, Karamlou T, Van Bergen AH, Overman D

Although perioperative prophylactic glucocorticoids have been used for decades, whether they improve outcomes in infants after heart surgery with cardiopulmonary bypass is unknown. This study was a multicenter, prospective, randomized, placebo-controlled, registry-based trial involving infants (<1 year of age) undergoing heart surgery with cardiopulmonary bypass at 24 sites participating in the Society of Thoracic Surgeons Congenital Heart Surgery Database.

Ampicillin dosing in premature infants for early-onset sepsis: exposure-driven efficacy, safety, and stewardship

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Journal of Perinatology • July 2022

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Le J, Greenberg RG, Yoo Y, Clark RH, Benjamin DK Jr., Zimmerman KO, Cohen-Wolkowiez M, Wade K
This study simulated ampicillin concentrations in newborns to define optimal ampicillin dosing for empiric early-onset sepsis (EOS) therapy in preterm neonates. For EOS in preterm infants, two ampicillin doses (50 mg/kg) provided optimal bactericidal exposures, while minimizing potential toxicity.