The purpose of this multicenter trial is to determine if indomethacin prevents bleeding in the brain of very low birth weight preterm infants.

Intraventricular hemorrhage (IVH) or bleeding in the brain remains a major problem of preterm infants. This randomized, placebo-controlled multicenter trial enrolled 505 infants of 600 to 1250g birth weight to determine if indomethacin lowers the incidence of IVH, and 125 term infant controls. During this longitudinal trial, follow-up assessments have been performed at the ages of 3, 4 1/2, 6 and 8. The initial results at age 3 years revealed no advantages to the indomethacin group over and above the decreases in IVH, however, the results did show a significant increase in ventriculomegaly in the indomethacin negative or "placebo" group. Later results at 4 1/2 and 6 years of age showed beneficial effects of indomethacin on cognitive and behavioral outcomes over and above the effects on preventing IVH. The study investigators continue to followup with the children to find out if early use of indomethacin will continue to improve the outcomes of extremely low birth weight children.

• Intraventricular Hemorrhage (IVH)
• Bleeding in the Brain
• Prematurity
• Very Low Birth Weight Infants

• Drug: indomethacin
• Other: placebo

• Active Comparator: indomethacin
• Placebo Comparator: placebo

• Preterm infants < 1250 g birth weight
• Admitted to participating institution < 6 hrs of age
• No evidence for congenital malformations
• Cranial US at 6 postnatal hours without evidence of Grades III - IV intraventricular hemorrhage