Author: Kayla Korzekwinski

Fluconazole Prophylaxis for the Prevention of Candidiasis in Premature Infants: A Meta-analysis Using Patient-level Data

Posted on by Kayla Korzekwinski

Clinical Infectious Diseases • August 2016

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Ericson JE, Kaufman DA, Kicklighter SD, Bhatia J, Testoni D, Gao J, Smith PB, Prather KO, Benjamin DK Jr; Fluconazole Prophylaxis Study Team on behalf of the Best Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committee.

Invasive candidiasis (IC) is an important cause of sepsis in premature infants and is associated with a high risk of death and neurodevelopmental impairment. Prevention of IC has become a major focus in very low birth weight infants, with fluconazole increasingly used as prophylaxis. We identified all randomized, placebo-controlled trials evaluating fluconazole prophylaxis in premature infants conducted in the United States.

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

Posted on by Kayla Korzekwinski

Journal of Pediatrics • August 2016

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Hornik CP, Benjamin DK Jr, Smith PB, Pencina MJ, Tremoulet AH, Capparelli EV, Ericson JE, Clark RH, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act—Pediatric Trials Network.

This was a retrospective observational cohort study of electronic health record (EHR) data combined with pharmacokinetic model derived drug exposure predictions. We used the EHR from 348 Pediatrix Medical Group neonatal intensive care units from 1997 to 2012. We included all infants 24-41 weeks gestational age, 500-5400 g birth weight, first exposed to ampicillin prior to 25 days postnatal age. In this cohort of hospitalized infants, higher ampicillin exposure was associated with seizures as documented in the EHR.

Adverse Events After Routine Immunization of Extremely Low Birth Weight Infants

Posted on by Kayla Korzekwinski

JAMA Pediatrics • August 2016

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DeMeo SD, Raman SR, Hornik CP, Wilson CC, Clark R, Smith PB
Immunization of extremely low birth weight (ELBW) infants in the neonatal intensive care unit (NICU) is associated with adverse events including fever and apnea/bradycardia in the immediate post-immunization period. This presents a diagnostic dilemma for clinicians, leading to the potential for immunization delay and sepsis evaluations. The goal of this study is to compare the incidence of sepsis evaluations, need for increased respiratory support, intubation, seizures, and death among immunized ELBW infants in the 3 days pre- and post-immunization.

Safety of histamine-2 receptor blockers in hospitalized VLBW infants

Posted on by Kayla Korzekwinski

Early Human Development • August 2016

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Romaine A, Ye D, Ao Z, Fang F, Johnson O, Blake T, Benjamin DK Jr, Cotten CM, Testoni D, Clark RH, Chu VH, Smith PB, Hornik CP; Best Pharmaceuticals for Children Act – Pediatric Trials Network.

Histamine-2 receptor (H2) blockers are often used in very low birth weight infants despite lack of population specific efficacy and safety data. We sought to describe safety and temporal trends in histamine-2 receptor (H2) blocker use in hospitalized very low birth weight (VLBW) infants.

Child in park playing with colorful blocks.

PTN mentioned by Huffington Post blogger who offers global and longitudinal view of pediatrics research

Posted on by Kayla Korzekwinski

Creating A Clinical Trial Strategy For Children’s Health Research

by 
Over the past few decades, children’s health has arguably made some of the greatest gains. Infant mortality in most developed countries has fallen dramatically from an estimated 30 per cent to less than one per cent. Infectious diseases, the primary cause of infant mortality, have been addressed with better sanitation and water quality, and the development of vaccines and innovative new therapies. Parents need only consider penicillin or vaccines for polio, whooping cough, meningitis, and chicken pox to get a sense of the stress that parents would have had just a few decades ago.
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Read the entire  blog post here.

Clindamycin Pharmacokinetics and Safety in Preterm and Term Infants

Posted on by Kayla Korzekwinski

Antimicrobial Agents and Chemotherapy • April 2016

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Gonzalez D, Delmore P, Bloom BT, Cotten CM, Poindexter BB, McGowan E, Shattuck K, Bradford KK, Smith PB, Cohen-Wolkowiez M, Morris M, Yin W, Benjamin DK Jr, Laughon MM.

Clindamycin may be active against methicillin-resistant Staphylococcus aureus, a common pathogen causing sepsis in infants, but optimal dosing in this population is unknown. We performed a multicenter, prospective pharmacokinetic (PK) and safety study of clindamycin in infants. We analyzed the data using a population PK analysis approach and included samples from two additional pediatric trials.

PTN Post: Issue 16 (March 2016)

Posted on by Kayla Korzekwinski

Check out the Spring 2016 issue of the PTN Post, the newsletter for the Pediatrics Trials Network. This issue highlights the continuation of the Sildenafil Cohort 2 program, the new role of Child and Family Advocate, and PTN’s presentations at the upcoming Pediatric Academic Society meeting in Baltimore.

We hope you enjoy this issue, and as always, we welcome your comments and feedback.

Optimizing operational efficiencies in early phase trials: The Pediatric Trials Network experience

Posted on by Kayla Korzekwinski

Contemporary Clinical Trials • March 2016

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England A, Wade K, Smith PB, Berezny K, Laughon M; Best Pharmaceuticals for Children Act — Pediatric Trials Network Administrative Core Committee.

Performing drug trials in pediatrics is challenging. In support of the Best Pharmaceuticals for Children Act, the Eunice Kennedy Shriver National Institute of Child Health and Human Development funded the formation of the Pediatric Trials Network (PTN) in 2010. Since its inception, the PTN has developed strategies to increase both efficiency and safety of pediatric drug trials. Through use of innovative techniques such as sparse and scavenged blood sampling as well as opportunistic study design, participation in trials has grown. The PTN has also strived to improve consistency of adverse event reporting in neonatal drug trials through the development of a standardized adverse event table. We review how the PTN is optimizing operational efficiencies in pediatric drug trials to increase the safety of drugs in children.

Insulin, Hyperglycemia, and Severe Retinopathy of Prematurity in Extremely Low-Birth-Weight Infants

Posted on by Kayla Korzekwinski

American Journal of Perinatology • March 2016

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Lee JH, Hornik CP, Testoni D, Laughon MM, Cotton CM, Maldonado RS, Belcastro MR, Clark RH, Smith PB

This study aimed to determine the association between hyperglycemia, insulin therapy, and severe retinopathy of prematurity (ROP) in extremely low-birth-weight (ELBW) infants. Hyperglycemia alone was not associated with severe ROP in ELBW infants. However, researchers did observe a possible trend between the use of insulin and severe ROP.