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Randomized indomethacin trial for prevention of intraventricular hemorrhage in very low birth weight infants
Insights
Indomethacin significantly reduced intraventricular hemorrhage in preterm infants. This drug also promoted closure of the patent ductus arteriosus, potentially protecting the brain.
Area of Science:
- Neonatal Medicine
- Pharmacology
- Pediatric Cardiology
Background:
- Neonatal intraventricular hemorrhage (IVH) is a serious complication in preterm infants.
- Patent ductus arteriosus (PDA) is common in preterm neonates and may be associated with IVH.
Purpose of the Study:
- To evaluate the efficacy of indomethacin in preventing neonatal intraventricular hemorrhage.
- To assess the effect of indomethacin on the closure of the patent ductus arteriosus.
Main Methods:
- A randomized prospective trial involving 48 preterm neonates (600-1250 gm birth weight).
- Infants received either intravenous indomethacin or placebo every 12 hours for five doses, starting at 6 postnatal hours.
- Cardiac ultrasound, urinary output, serum electrolytes, and renal/clotting functions were monitored.
Main Results:
- Six infants in the indomethacin group had IVH compared to 14 in the placebo group (P = 0.02).
- Indomethacin treatment led to significant decreases in serum prostaglandin levels.
- PDA closure occurred in 84% of indomethacin-treated infants versus 60% of placebo-treated infants.
Conclusions:
- Indomethacin significantly reduces the incidence of intraventricular hemorrhage in preterm neonates.
- Indomethacin effectively promotes the closure of the patent ductus arteriosus in this population.
- Indomethacin may offer protection against neonatal IVH, possibly through effects on cerebral microvasculature.
Abstract:
We admitted 48 preterm neonates (600 to 1250 gm birth weight, normal 6-hour echoencephalograms) to a randomized prospective indomethacin or placebo trial for the prevention of neonatal intraventricular hemorrhage. Beginning at 6 postnatal hours, indomethacin or placebo was administered intravenously every 12 hours for a total of five doses. Cardiac ultrasound studies to assess the status of the ductus arteriosus were performed at 6 postnatal hours and on day 5. Urinary output, serum electrolytes, and renal and clotting functions were monitored. No differences in birth weight, gestational age, Apgar scores, or ventilatory needs were noted between the two groups. Six infants given indomethacin had intraventricular hemorrhage, compared to 14 control infants (P = 0.02). The indomethacin-treated group had significant decreases in serum prostaglandin values 30 hours after the initiation of therapy. The overall incidence of patent ductus arteriosus was 82% at 6 postnatal hours; 84% of the indomethacin-treated infants experienced closure of the ductus, compared to 60% of the placebo-treated patients. Closure of the ductus was not related to incidence of intraventricular hemorrhage. We speculate that indomethacin may provide some protection against neonatal intraventricular hemorrhage by acting on the cerebral microvasculature.