A comparison of ibuprofen and indomethacin for closure of patent ductus arteriosus

Background Indomethacin is the conventional treatment for patent ductus art eriosus in preterm infants. However, its use is associated with various sid e effects In a prospective study, we compared ibuprofen and indomethacin wi th regard to efficacy and safety for the early treatment of patent ductus a rteriosus in preterm infants. Methods We studied 148 infants (gestational age, 24 to 32 weeks) who had th e respiratory distress syndrome and an echocardiographically confirmed duct us arteriosus. The infants were at five neonatal intensive care centers to receive three intravenous doses of either cin (0.2 mg per kilogram of body weight, given at 12-hour intervals) or ibuprofen (a first dose of 10 mg per kilogram, followed at 24-hour intervals by two doses of 5 mg per kilogram each), starting on the third of life. The rate of ductal closure, the need for additional treatment, side effects, complications, and the infants clin ical course were recorded. Results The rate of ductal closure was similar with the two treatments: duc tal closure occurred in 49 of infants given indomethacin (66 percent), and in 52 of 74 given ibuprofen (70 percent) (relative risk, 0.94; 95 percent c onfidence interval, 0.76 to 117; P=0.41). The numbers of infants who needed a second pharmacologic treatment or surgical ductal ligation did not diffe r significantly between the two groups. Oliguria occurred in 5 infants trea ted with ibuprofen and in 14 treated with indomethacin ( P=0.03). There wer e no significant differences with respect to other side effects or complica tions. Conclusions Ibuprofen therapy on the third day of life is as efficacious as indomethacin for the treatment of patent ductus arteriosus in preterm infa nts with the respiratory distress syndrome and is less likely to induce oli guria. (N Engl J Med 2000; 343: 674-81.) (C) 2000, Massachusetts Medical So ciety.