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Volume 343:674-681 September 7, 2000 Number 10 Next

	Full Text PDF Editorial by Clyman, R. I. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background Indomethacin is the conventional treatment for patent ductus arteriosus in preterm infants. However, its use is associated with various side effects. In a prospective study, we compared ibuprofen and indomethacin with regard to efficacy and safety for the early treatment of patent ductus arteriosus in preterm infants.

Methods We studied 148 infants (gestational age, 24 to 32 weeks) who had the respiratory distress syndrome and an echocardiographically confirmed patent ductus arteriosus. The infants were randomly assigned at five neonatal intensive care centers to receive three intravenous doses of either indomethacin (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 day of life. The rate of ductal closure, the need for additional treatment, side effects, complications, and the infants' clinical course were recorded.

Results The rate of ductal closure was similar with the two treatments: ductal closure occurred in 49 of 74 infants given indomethacin (66 percent), and in 52 of 74 given ibuprofen (70 percent) (relative risk, 0.94; 95 percent confidence interval, 0.76 to 1.17; P=0.41). The numbers of infants who needed a second pharmacologic treatment or surgical ductal ligation did not differ significantly between the two groups. Oliguria occurred in 5 infants treated with ibuprofen and in 14 treated with indomethacin (P=0.03). There were no significant differences with respect to other side effects or complications.

Conclusions Ibuprofen therapy on the third day of life is as efficacious as indomethacin for the treatment of patent ductus arteriosus in preterm infants with the respiratory distress syndrome and is significantly less likely to induce oliguria. (N Engl J Med 2000;343: 674-81.)

Source Information

From the Department of Pediatrics, Division of Neonatology, University Hospital Antwerp (B.V.O., K.D.); the Department of Pediatrics, Division of Neonatology, Ghent University Hospital (K.S.); the Neonatal Intensive Care Unit, Sint Jan Ziekenhuis, Bruges (D.L.); the Neonatal Intensive Care Unit, Queen Paola Children's Hospital, Antwerp (H.V.B.); the Department of Epidemiology and Community Medicine, University of Antwerp (J.W.); and the Neonatal Intensive Care Unit, Clinique Saint Vincent, Rocourt (J.-P.L.) — all in Belgium.

Address reprint requests to Dr. Van Overmeire at the Department of Pediatrics, Division of Neonatology, University Hospital Antwerp, Wilrijkstraat 10, B-2650 Edegem, Belgium, or at bart.van. overmeire{at}uza.uia.ac.be.

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