Indomethacin prophylaxis for lntraventricular hemorrhage in very low birth babies a randomized controlled trial

ABSTRACT

This work aimed at studying the efficacy and complications of low dose Indomethacin in the reduction of major intraventricular hemorrhage [IVH] in very low birth weight [VLBW] babies. The study was a prospective randomized controlled trial [mid term interim analysis]. The setting was level III neonatal intensive care unit of a perinatal tertiary care centre. Newborn babies with two birth weight categories [a]750 999 and [b]1000 -1250 gm born from January 1998 to March 2001 at Royal Hospital were randomized to one of two groups Indomethacin or control. Three doses of indomethacin were administered to the indomethacin group in each birth weight category in the dose of 0.1 mg/kg/dose intravenously over a period of not less than 30 minutes. First dose was commenced between 6 to 12 hrs of age, and two additional doses were administered at 12 hourly intervals if the head ultra sound [U/S] detected no IVH. The control group did not receive any specific intervention other than normal neonatal intensive care. The primary outcome measure was the occurrence of NH and the secondary outcome measures were Necrotizing enterocolitis [NEC], Symptomatic patent ductus arteriosus [PDA], Bleeding episodes, Renal Failure, Chronic Lung disease [CLD] and death