Neonates

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.

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.

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.

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.

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.

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.

Use and Safety of Erythromycin and Metoclopramide in Hospitalized Infants

Posted on by Kayla Korzekwinski

Journal of Pediatric Gastroenterology and Nutrition • August 2015

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Ericson JE, Arnold C, Cheeseman J, Cho J, Kaneko S, Wilson E, Clark RH, Benjamin DK Jr, Chu V, Smith PB, Hornik CP; Best Pharmaceuticals for Children Act–Pediatric Trials Network Administrative Core Committee.

Prokinetic medications are used in premature infants to promote motility and decrease time to full enteral feeding. Erythromycin and metoclopramide are the most commonly used prokinetic medications in the neonatal intensive care unit (NICU), but their safety profile is not well defined.

Safety of octreotide in hospitalized infants

Posted on by Kayla Korzekwinski

Early Human Development • July 2015

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Testoni D, Hornik CP, Neely ML, Yang Q, McMahon AW, Clark RH, Smith PB; Best Pharmaceuticals for Children Act — Pediatric Trials Network Administrative Core Committee.

Octreotide is used off-label in infants for treatment of chylothorax, congenital hyperinsulinism, and gastrointestinal bleeding. The safety profile of octreotide in hospitalized infants has not been described; we sought to fill this information gap.