Journal of Perinatology • July 2020
Wolf MF, Childers J, Gray KD, Chivily C, Glenn M, Jones L, Kpa M, McMannen T, Reyes I, Zimmerman KO, Clark RH, Greenberg RG
A letter from the author in response to comment on “Exchange transfusion safety and outcomes in neonatal hyperbilirubinemia.”
Journal of the American Academy of Dermatology • March 2020
Drolet BA, Boakye-Agyeman F, Harper B, Holland K, Lewandowski A, Stefanko N, Melloni C
Off-label ophthalmic timolol has been rapidly adopted for treatment of infantile hemangioma since topical application of β-blockers was presumed to have an improved safety profile compared with that of oral administration. We examined timolol plasma concentrations in children receiving ophthalmic preparations applied to skin hemangiomas. Timolol was detected in 86 of 92 plasma samples (93%). We predicted that young infants would have higher plasma concentrations but found that older infants (6-12 months) had the highest concentrations. Subsequently, we analyzed the effect of hemangioma size and thickness on plasma concentrations. Only hemangioma thickness significantly predicted plasma concentrations.
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 Clinical Pharmacology • December 2019
Hornik CP, Yogev R, Mourani PM, Watt KM, Sullivan JE, Atz AM, Speicher D, Al-Uzri A, Adu-Darko M, Payne E, Gelber C, Lin S, Harper B, Melloni C, Cohen-Wolkowiez M, Gonzalez D
Milrinone is a type 3 phosphodiesterase inhibitor used to improve cardiac output in critically ill infants and children. Milrinone is primarily excreted unchanged in the urine, raising concerns for toxic accumulation in the setting of renal dysfunction of critical illness. We developed a population pharmacokinetic model of milrinone using nonlinear mixed-effects modeling in NONMEM to perform dose-exposure simulations in children with variable renal function. Children below 21 years of age were included.
Antimicrobial Agents and Chemotherapy • September 2019
Thompson EJ, Wu H, Melloni C, Balevic S, Sullivan JE, Laughon M, Clark KM, Kalra R, Mendley S, Payne E, Erinjeri J, Gelber C, Harper B, Cohen-Wolkoweiz M, Hornik CP
Doxycycline is a tetracycline-class antimicrobial labeled by the United States (U.S.) Food and Drug Administration for children >8 years of age for many common childhood infections. Doxycycline is not labeled for children ≤8 years of age, due to the association between tetracycline class antibiotics and tooth staining. We leveraged opportunistically-collected plasma samples after intravenous (IV) and oral doxycycline doses received per standard of care to characterize the pharmacokinetics (PK) of doxycycline in children of different ages between 0 and 18 years.
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.
Journal of Pediatrics • August 2019
Puia-Dumitrescu M, Smith PB, Zhao J, Soriano A, Payne EH, Harper B, Bendel-Stenzel E, Moya F, Chhabra R, Ku L, Laughon M, Wade KC
Aim to characterize the dosing and safety of off-label caffeine citrate in a contemporary cohort of extremely premature infants. We used electronic health records (2010-2013) from 4 neonatal intensive care units to identify infants of ≤28 weeks of gestational age exposed to caffeine citrate. Of 410 infants with a median (IQR) gestational age of 26 (24-27) weeks, 95% received caffeine citrate for >0 days. Infants received a median (IQR) daily dose of 8 (5-10) mg/kg/day. Incidences of clinical events on day of caffeine citrate exposure were death 2%, patent ductus arteriosus ligation 12%, and medical and surgical necrotizing enterocolitis 5% and 4%, respectively.
