Dosing and Safety of Off-label Use of Caffeine Citrate in Premature Infants.

The Journal of Pediatrics
Mihai Puia-DumitrescuBest Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committee

Abstract

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. Safety outcomes included death, bronchopulmonary dysplasia, necrotizing enterocolitis, spontaneous intestinal perforation, intraventricular hemorrhage, patent ductus arteriosus ligation, seizures, and arrhythmias. We used multivariable logistic regression to evaluate the association of caffeine citrate exposure with clinical events. 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. Bronchopulmonary dysplasia occurred in 37% of infants and was not associated with caffeine dose. Increased caffeine citrate dose was associated with lower odds of patent ductus arteriosus ligation and necrotizing enterocolitis. Caffeine citrate w...Continue Reading

Citations

Aug 2, 2020·Journal of Clinical Pharmacy and Therapeutics·Aijie GuoHongjuan Xie
Mar 14, 2021·Journal of Perinatology : Official Journal of the California Perinatal Association·Grant EricksonCarl E Hunt
Feb 19, 2020·American Journal of Perinatology·Ozkan Ilhan, Meltem Bor
Aug 24, 2021·The Journal of Pediatric Pharmacology and Therapeutics : JPPT : the Official Journal of PPAG·Laura A SalemiJamie L Miller

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