Journal of Perinatology • July 2022
Journal of Perinatology • January 2022
Journal of the Pediatric Infectious Diseases Society • May 2021
Pediatric Infectious Disease Journal • September 2020
Commander SJ, Gao J, Zinkhan EK, Heresi G, Courtney SE, Lavery AP, Delmore P, Sokol GM, Moya F, Benjamin DK Jr, Bumpass TG, Debski J, Erinjeri J, Sharma G, Tracy ET, Cohen-Wolkowiez M, Hornik CP; on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee
Metronidazole is frequently used off-label in infants with complicated intra-abdominal infections (cIAI) to provide coverage against anaerobic organisms, but its safety and efficacy in this indication are unknown. Metronidazole safety was evaluated by reporting of adverse events (AEs) and safety events of special interest. In a cohort of late pre-term and term infants with cIAIs, combination antibiotic therapy that included metronidazole was safe, and therapeutic success was high.
Journal of Pediatrics • July 2020
Gray KD, Messina JA, Cortina C, Owens T, Fowler M, Foster M, Gbadegesin S, Clark RH, Benjamin DK, Zimmerman KO, Greenberg RG
This study sought to determine the prevalence of probiotic administration in infants born preterm over time, as well as the association between probiotic administration and select adverse outcomes. Probiotic use increased over the study period and varied among neonatal intensive care units. Probiotic administration was associated with a decrease in NEC and death, and an increase in Candida infection, but no increase in bloodstream infection or meningitis.
Journal of Perinatology • February 2020
This study evaluated the most commonly used medications and in-hospital morbidities and mortality in infants born 22-24 weeks of gestation. It was a multicenter retrospective cohort study of infants born 22-24 weeks of gestation, from 2006-2016, without major congenital anomalies and with available medication data obtained from neonatal intensive care units managed by the Pediatrix Medical Group. A large number of medications were used in periviable infants. There was a high prevalence of in-hospital morbidities, and survival of this population increased over the study period.
Journal of Parenteral and Enteral Nutrition • February 2020
Puia-Dumitrescu M, Benjamin DK Sr, Smith PB, Greenberg RG, Abuzaid N, Andrews W, Chellani K, Gupta A, Price D, Williams C, Malcolm WF, Clark RH, Zimmerman KO
Gastrostomy tube (G-tube) placement is a long-term alternative to oral or nasogastric feeding for premature infants who cannot safely feed orally or need supplemental nutrition for growth. We compared daily weight changes for G-tube infants 14 and 30 days preplacement and postplacement, excluding the first 7 days post-G-tube insertion. We also estimated a treatment effect model in which infants with a G-tube were matched 1:1 to untreated controls based on propensity scores; main outcome was the average treatment effect (weight gain) for treated infants during the 7, 14, or 30 days immediately prior to discharge.
BMC Pediatrics • January 2020
Abdel-Rahman SM, Paul IM, Delmore P, Chen JY, Mills M, Greenberg RG, on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network
Weight is critical for the medical management of infants; however, scales can be unavailable or inaccessible in some practice settings. We recently developed and validated a robust infant weight estimation method based on chest circumference (CC) and head circumference (HC). Among 486 infants enrolled, predicted weight was within 10 and 15% of actual weight in 86 and 99%, of infants. This device can be used to estimate weight in infants when calibrated scales are impractical or unavailable.
British Journal of Clinical Pharmacology • December 2019
Gonzalez D, Laughon MM, Smith PB, Ge S, Ambalavanan N, Atz A, Sokol GM, Hornik CD, Stewart D, Mundakel G, Poindexter BB, Gaedigk R, Mills M, Cohen-Wolkowiez M, Martz K, Hornik CP
We performed a multicentre, open-label trial to characterize the pharmacokinetics (PK) of sildenafil in infants ≤28 weeks gestation and < 365 postnatal days (cohort 1) or < 32 weeks gestation and 3-42 postnatal days (cohort 2). We successfully characterized the PK of sildenafil and DMS in premature infants and applied the model to inform dosing for a follow-up, phase II study.
Journal of Perinatology • September 2019
Gonski S, Hupp S, Cotton CM, Clark R, Laughon M, Watt K, Hornik CP, Smith PB, Greenberg RG
Aim to quantify the risk of treatment for retinopathy of prematurity (ROP) among infants meeting current U.S. screening guidelines. Among infants ≤1500 g birth weight or ≤30 weeks gestation screened for ROP from 2006-2015, we developed a risk prediction model to identify infants treated for ROP. Applied to 6,127 infants discharged in 2016, our model had 97.9% sensitivity, 63.3% specificity, positive predictive value of 4.0%, and negative predictive value of 99.9%. Large numbers of infants at low risk of developing ROP are required to undergo screening. Refining current ROP guidelines may reduce unnecessary examinations.
