Neonates

Medications and In-hospital Outcomes in Infants Born at 22-24 Weeks Gestation

Posted on by Kayla Korzekwinski

Journal of Perinatology • February 2020

Puia-Dumitrescu M, Younge N, Benjamin DK, Lawson K, Hume C, Hill K, Mengistu J, Wilson A, Zimmerman ZO, Ahmad K, Greenberg RG; on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network

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.

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Impact of Gastrostomy Tube Placement on Short-Term Weight Gain in Hospitalized Premature Infants

Posted on by Kayla Korzekwinski

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.

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Validation and human factor analysis study of an infant weight estimation device

Posted on by Kayla Korzekwinski

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.

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Population pharmacokinetics of sildenafil in extremely premature infants

Posted on by Kayla Korzekwinski

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.

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Risk of Development of Treated Retinopathy of Prematurity in Very Low Birth Weight Infants

Posted on by Kayla Korzekwinski

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.

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The use of supplemental hydrocortisone in the management of persistent pulmonary hypertension of the newborn

Posted on by Kayla Korzekwinski

Journal Perinatology • April 2021

Aleem S, Robbins C, Murphy B, Elliott S, Akinyemi C, Paredes N, Tolia VN, Zimmerman KO, Goldberg RN, Benjamin DK, Greenberg RG

 

This study aimed to characterize the association between hydrocortisone receipt and hospital outcomes of infants with persistent pulmonary hypertension of the newborn (PPHN). There was no association between hydrocortisone receipt and death, CLD, or oxygen at discharge in our cohort. Prospective studies are needed to evaluate the effectiveness of hydrocortisone in infants with PPHN.

 

 

Safety, Effectiveness, and Exposure-Response of Micafungin in Infants: Application of an Established Pharmacokinetics Model to Electronic Health Records

Posted on by Kayla Korzekwinski

The Pediatric Infectious Disease Journal • February 2020

Rivera-Chaparro ND, Ericson J, Wu H, Smith BP, Clark RH, Benjamin DK, Cohen-Wolkowiez M, Greenberg RG

 

Micafungin is used off-label in the United States to treat invasive candidiasis in neonates. This study used an established pharmacokinetic model to determine micafungin exposures for 46 courses in 39 hospitalized infants. In this small cohort of infants, micafungin exposure was not associated with laboratory markers of liver toxicity, death, or failure of microbiological clearance.

 

Rifampin Pharmacokinetics and Safety in Preterm and Term Infants

Posted on by Kayla Korzekwinski

Antimicrobial Agents and Chemotherapy • May 2019.

Smith PB, Cotten CM, Hudak ML, Sullivan JE, Poindexter BB, Cohen-Wolkowiez M, Boakye-Agyeman F, Lewandowski A, Anand R, Benjamin DK Jr, Laughon MM; Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee.

Rifampin is active against methicillin-resistant staphylococcal species and tuberculosis (TB). We performed a multicenter, prospective pharmacokinetic (PK) and safety study of intravenous rifampin in infants of <121 days postnatal age (PNA). We enrolled 27 infants; the median (range) gestational age was 26 weeks (23 to 41 weeks), and the median PNA was 10 days (0 to 84 days). We collected 102 plasma PK samples from 22 of the infants and analyzed safety data from all 27 infants. We analyzed the data using a population PK approach.

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Physiologically-Based Pharmacokinetic Modeling of Fluconazole Using Plasma and Cerebrospinal Fluid Samples From Preterm and Term Infants

Posted on by Kayla Korzekwinski

CPT: Pharmacometrics & Systems Pharmacology • May 2019

Gerhart JG, Watt KM, Edginton A, Wade KC, Salerno SN, Benjamin DK, Smith PB, Hornik CP, Cohen-Wolkowiez M, Duara S, Ross A, Shattuck K, Stewart DL, Neu N, Gonzalez D, on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee

 

Fluconazole is used to treat hematogenous Candida meningoencephalitis in preterm and term infants. To characterize plasma and central nervous system exposure, an adult fluconazole physiologically-based pharmacokinetic (PBPK) model was scaled to infants, accounting for age dependencies in glomerular filtration and metabolism. Target attainment in plasma and CSF was reached faster after incorporating a loading dose of 25 mg/kg. PBPK modeling can be useful in exploring CNS kinetics of drugs in children.

 

National Survey of Neonatal Intensive Care Unit Medication Safety Practices

Posted on by Kayla Korzekwinski

American Journal of Perinatology • November 2018.

Greenberg RG, Smith PB, Bose C, Clark RH, Cotten CM, DeRienzo C.

We conducted a detailed survey to identify medication safety practices among a large network of United States neonatal intensive care units (NICUs). We created a 53-question survey to assess 300 U.S. NICU’s demographics, medication safety practices, adverse drug event (ADE) reporting, and ADE response plans.

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