Low-Dose Indomethacin and Prevention of Intraventricular Hemorrhage: A Multicenter Randomized Trial

• DOI: 10.1542/peds.93.4.543
• Publication Date: 2021-12-11T07:55:42Z
• Authors: Laura R. Ment; Richard A. Ehrenk...; Charles C. Duncan; David T. Scott; Kenneth J.W. Taylor; Karol H. Katz; Karen C. Schneider; Robert W. Makuch; William Oh; Betty Vohr; Alistair G.S. Philip; Walter Allan
• Keywords: Ductus arteriosus; Apgar score; Bronchopulmonary Dysplasia

Objectives. Parenchymal involvement of intraventricular hemorrhage (IVH) is a major risk factor for neurodevelopmental handicap in very low birth weight neonates. Previous trials have suggested that indomethacin would lower the incidence and severity IVH Methods. We enrolled 431 neonates 600- to 1250-g with no evidence at 6 11 hours age prospective, randomized, placebo-controlled trial test hypothesis low-dose (0.1 mg/kg intravenously 12 postnatal every 24 two more doses) IVH. Serial cranial ultrasound examinations echocardiographs were performed. Results. There differences weight, gestational age, sex, Apgar scores, percent treated surfactant between placebo groups. Within first 5 days, 25 (12%) indomethacin-treated 40 (18%) placebo-treated developed (P = .03, trend test). Only one patient experienced grade 4 compared 10 .01). Sixteen 29 control died .08); there was difference favoring respect survival time .06). Eighty-six all had patent ductus arteriosus on day; associated significant ductal closure by fifth day life < .001). adverse events attributed treatment Conclusions. Low-dose prophylactic significantly lowers IVH, particularly severe form (grade IVH). In addition,indomethacin closes not drug