Author: Kayla Korzekwinski

Pharmacokinetics and bioequivalence of a liquid formulation of hydroxyurea in children with sickle cell anemia

Posted on by Kayla Korzekwinski

The Journal of Clinical Pharmacology • March 2016

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Estepp JH, Melloni C, Thornburg CD, Wiczling P, Rogers Z, Rothman JA, Green NS, Liem R, Brandow AM, Crary SE, Howard TH, Morris MH, Lewandowski A, Garg U, Jusko WJ, Neville KA; Best Pharmaceuticals for Children Act-Pediatric Trials Network Administrative Core Committee.

Hydroxyurea (HU) is a crucial therapy for children with sickle cell anemia, but its off-label use is a barrier to widespread acceptance. We found HU exposure is not significantly altered by liquid vs capsule formulation, and weight-based dosing schemes provide consistent exposure. HU is recommended for all children starting as young as 9 months of age with sickle cell anemia; however; a paucity of pediatric data exists regarding the pharmacokinetics (PK) or the exposure-response relationship of HU.

Sildenafil and retinopathy of prematurity risk in very low birth weight infants

Posted on by Kayla Korzekwinski

American Journal of Perinatology • February 2016

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Samiee-Zafarghandy S, van den Anker JN, Laughon MM, Clark RH, Smith PB, Hornik CP; Pharmaceuticals for Children Act – Pediatric Trials Network Administrative Core Committee.

We identified premature infants who were discharged from Pediatrix Medical Group neonatal intensive care units from 2003–2012 and who received an ophthalmologic exam. We matched each infant exposed to sildenafil prior to first eye exam to three non-exposed infants using propensity scoring to control for differences in baseline infant characteristics. We evaluated the association between sildenafil exposure and development of severe ROP using conditional logistic regression.

Dosing in neonates: Special considerations in physiology and trial design

Posted on by Kayla Korzekwinski

Pediatric Research • January 2016

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Ku LC, Smith PB
Determining the right dose for drugs used to treat neonates is critically important. Neonates have significant differences in physiology affecting drug absorption, distribution, metabolism, and elimination that makes extrapolating dosages from adults and older children inappropriate. Fortunately, specialized analytical techniques, such as the use of dried blood spots, scavenged sampling, population pharmacokinetics analyses, and sparse sampling, have helped investigators better define doses that maximize efficacy and safety. Through the use of these methods, successful clinical trials have resulted in recent changes to drug dosing in this population.

PTN Post: Issue 15 (December 2015)

Posted on by Kayla Korzekwinski

Check out the Fall-Winter 2015 issue of the PTN Post, the newsletter for the Pediatrics Trials Network. This issue highlights four exciting PTN projects: timolol in infants with hemangiomas; anti-epileptics and pantoprazole for obese children; and furosemide for BPD. We hope you enjoy this issue and as always, we welcome your comments and feedback.

Effect of Catheter Dwell Time on Risk of Central Line–Associated Bloodstream Infection in Infants

Posted on by Kayla Korzekwinski

Pediatrics • December 2015

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Greenberg RG, Cochran KM, Smith PB, Edson BS, Schulman J, Lee HC, Govindaswami B, Pantoja A, Hardy D, Curran J, Lin D, Kuo S, Noguchi A, Itmann P, Duncan S, Gupta M, Piccarillo A, Karna P, Cohen M, Giuliano M, Carroll S, Page B, Guzman-Cottrill J, Walker

Central venous catheters in the NICU are associated with significant morbidity and mortality because of the risk of central line–associated bloodstream infections (CLABSIs). The purpose of this study was to determine the effect of catheter dwell time on risk of CLABSI. Increased dwell time was not associated with increased risk of CLABSI for PICCs. For tunneled catheters, infection incidence was significantly higher in weeks 7 and 9 compared with week 1.

Enteral Feeding With Human Milk Decreases Time to Discharge in Infants Following Gastroschisis Repair

Posted on by Kayla Korzekwinski

The Journal of Pediatrics • December 2015

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Gulack BC, Laughon MM, Clark RH, Burgess T, Robinson S, Muhammad A, Zhang A, Davis A, Morton R, Chu VH, Arnold CW, Hornik CP, Smith PB

This study reviewed a multi-institutional database to assess the effect of enteral feeding with human milk on duration from initiation of feeds to discharge after gastroschisis repair. The use of human milk for enteral feeding of infants following repair of gastroschisis significantly reduces the time to discharge from initiation of feeds.

Vancomycin Cerebrospinal Fluid Pharmacokinetics in Children with Cerebral Ventricular Shunt Infections

Posted on by Kayla Korzekwinski

The Pediatric Infectious Disease Journal • October 2015

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Autmizguine J, Moran C, Gonzalez D, Capparelli EV, Smith PB, Grant GA, Benjamin DK Jr, Cohen-Wolkowiez M, Watt KM.
This study described the cerebrospinal fluid (CSF) exposure of vancomycin in 8 children prescribed intravenous vancomycin therapy for cerebral ventricular shunt infection.

Gaps in Drug Dosing for Obese Children: A Systematic Review of Commonly Prescribed Emergency Care Medications

Posted on by Kayla Korzekwinski

Clinical Therapy • September 2015

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Rowe S, Siegel D, Benjamin DK Jr; Best Pharmaceuticals for Children Act – Pediatric Trials Network Administrative Core Committee.

Approximately 1 of 6 children in the United States is obese. This has important implications for drug dosing and safety because pharmacokinetic (PK) changes are known to occur in obesity due to altered body composition and physiologic mechanisms. Inappropriate drug dosing in an emergency setting can limit therapeutic efficacy and increase drug-related toxic effects for obese children.

Cefepime and Ceftazidime Safety in Hospitalized Infants

Posted on by Kayla Korzekwinski

The Pediatric Infectious Disease Journal • August 2015

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Arnold CJ, Ericson J, Cho N, Tian J, Wilson S, Chu VH, Hornik CP, Clark RH, Benjamin DK Jr, Smith PB; Best Pharmaceuticals for Children Act–Pediatric Trials Network Administrative Core Committee.

Cefepime and ceftazidime are cephalosporins used for the treatment of serious Gram-negative infections. These cephalosporins are used off-label in the setting of minimal safety data for young infants. We identified all infants discharged from 348 neonatal intensive care units managed by the Pediatrix Medical Group between 1997 and 2012 who were exposed to either cefepime or ceftazidime in the first 120 days of life. We reported clinical and laboratory adverse events occurring in infants exposed to cefepime or ceftazidime and used multivariable logistic regression to compare the odds of seizures and death between the 2 groups.

PTN Post: Issue 14 (August 2015)

Posted on by Kayla Korzekwinski

Check out the Summer 2015 issue of the PTN Post newsletter. This issue features a look back at the progress that has been made to date and a look ahead to our goals for the future, as well as announcements for exciting conference opportunities in the coming months. We hope you enjoy this issue and as always, we welcome your comments and feedback.