Background Indomethacin is the conventional treatment for patentductus arteriosus in preterm infants. However, its use is associatedwith various side effects. In a prospective study, we comparedibuprofen and indomethacin with regard to efficacy and safetyfor the early treatment of patent ductus arteriosus in preterminfants.
Methods We studied 148 infants (gestational age, 24 to 32 weeks)who had the respiratory distress syndrome and an echocardiographicallyconfirmed patent ductus arteriosus. The infants were randomlyassigned at five neonatal intensive care centers to receivethree intravenous doses of either indomethacin (0.2 mg per kilogramof body weight, given at 12-hour intervals) or ibuprofen (afirst dose of 10 mg per kilogram, followed at 24-hour intervalsby two doses of 5 mg per kilogram each), starting on the thirdday of life. The rate of ductal closure, the need for additionaltreatment, side effects, complications, and the infants' clinicalcourse were recorded.
Results The rate of ductal closure was similar with the twotreatments: ductal closure occurred in 49 of 74 infants givenindomethacin (66 percent), and in 52 of 74 given ibuprofen (70percent) (relative risk, 0.94; 95 percent confidence interval,0.76 to 1.17; P=0.41). The numbers of infants who needed a secondpharmacologic treatment or surgical ductal ligation did notdiffer significantly between the two groups. Oliguria occurredin 5 infants treated with ibuprofen and in 14 treated with indomethacin(P=0.03). There were no significant differences with respectto other side effects or complications.
Conclusions Ibuprofen therapy on the third day of life is asefficacious as indomethacin for the treatment of patent ductusarteriosus in preterm infants with the respiratory distresssyndrome 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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