A double blind study of the effects of oral indomethacin in preterm infants with patent ductus arteriosus who failed medical management.

Over a two year period, 52 infants were found to have clinical signs of patent ductus arteriosus (PDA). Twenty-seven responded to fluid restriction and furosemide; the remaining 25 infants entered the Indomethacin (IN) study protocol. Their mean (+/- SE) gestational age was 29.3 (+/- 0.6) weeks and birth weight was 1,142 (+/- 80) gm. Either a placebo or IN (0.25 mg/kg) orally was given for two doses, 24 hours apart; if no response occurred, the patient was crossed over to the opposite medication. Using Chi-square analysis, a significant response rate to IN was found. There were no significant differences in birth weights, gestational ages, or fluid intake between responders and nonresponders. However, both responders and nonresponders required a prolonged ventilator course, suggesting factors other than PDA causing prolonged ventilatory requirements in these babies.

RCT Entities:   Population Interventions Outcomes