Journal of Neonatal-Perinatal Medicine • June 2020
Dallefeld SH, Smith PB, Crenshaw EG, Daniel KR, Gilleskie ML, Smith DS, Balevic S, Greenberg RG, Chu V, Clark R, Kumar KR, Zimmerman KO
Given the limited available evidence on chloral hydrate safety in neonatal populations and the discrepancy in chloral hydrate acceptance between the US and other countries, we sought to clarify the safety profile of chloral hydrate compared to other sedatives in hospitalized infants.
The Pediatric Infectious Disease Journal • February 2020
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.
The Journal of Pediatrics • May 2019
Taylor G, Jackson W, Hornik CP, Koss A, Mantena S, Homsley K, Gattis B, Kudumu-Clavell M, Clark R, Smith PB, Laughon MM
This study evaluated how frequently surfactant is used off-label in preterm infants. The majority of surfactant given to preterm infants is administered off-label. The uptrend in administration via INSURE coincides with increased supporting evidence. The gap between FDA labeling and current clinic practice exemplifies an opportunity for label expansion, which may require additional prospective or retrospective safety and/or effectiveness data for infants of older GA and higher birth weight.
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.
American Journal of Perinatology • February 2019
Thompson EJ, Perez K, Hornik CP, Smith PB, Clark RH, Laughon M; Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee
Pulmonary hypertension causes substantial morbidity and mortality in infants. Although Food and Drug Administration approved to treat pulmonary arterial hypertension in adults, sildenafil is not approved for infants. This study sought to describe sildenafil exposure and associated diagnoses and outcomes in infants.
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.
The Journal of Pediatrics • November 2018
Kumar KR, Clark DA, Kim E, Perry JD, Wright K, Thomas SA, Thompson EJ, Greenberg RG, Smith PB, Benjamin DK, Laughon MM, Clark RH, Hornik CP
This study evaluated the association between the presence of an atrial septal defect (ASD) and the odds of developing bronchopulmonary dysplasia (BPD) in premature infants. The presence of an ASD was associated with an increased odds of BPD in this cohort. Future trials should consider ASD as a potentially modifiable risk factor in this vulnerable population.
The Journal of Pediatrics • November 2018
Romaine A, Clark RH, Davis B, Hendershot K, Kite V, Laughon M, Updike I, Miranda ML, Meier PP, Patel AL, Smith PB, Cotton CM, Benjamin DK Jr, Greenberg RG
This study identified factors associated with prolonged maternal breast milk (BM) provision in very low birth weight (VLBW) infants. Results suggest that maternal-infant demographic and clinical factors and household neighborhood socioeconomic characteristics were associated with provision of maternal BM at 30 postnatal days to VLBW infants. Identification of these factors allows providers to anticipate mothers’ needs and develop tailored interventions designed to improve rates of prolonged maternal BM provision and infant outcomes.
Early Human Development • October 2018
Wang LA, Smith PB, Laughon M, Goldberg RN, Ku LC, Zimmerman KO, Balevic S, Clark RH, Benjamin DK, Greenberg RG; Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee.
At very high doses, furosemide is linked to ototoxicity in adults, but little is known about the risk of hearing loss in premature infants exposed to furosemide. Our aim was to evaluate the association between prolonged furosemide exposure and abnormal hearing screening in premature infants.
