Introduction: Ibuprofen is emerging as a reasonable alternative to indomethacin for closing patent ductus arteriosus (PDA) in preterm infants with respiratory distress syndrome (RDS) (Arch Dis Child 97;76:F179). Moreover it has been shown that it does not reduce cerebral blood flow and causes less impairment of intestinal hemodynamics.

Objective: To evaluate efficiency and side effects of ibuprofen as compared to indomethacin for early treatment of PDA in preterm infants with RDS.

Design and Setting: Randomized prospective multicenter trial at tertiary level NICU's.

Patients and Methods: 103 preterm infants with RDS, after rescue treatment with exogenous surfactant, on artificial ventilation, with echocardiographically proven PDA on day 3 of life, were randomized to either indomethacin i.v. (INDO) 3× 0.2 mg / kg at 12 hr intervals (birth weight(BW): 1240 ± 370 g; gestational age (GA): 29.1 ± 2.0 wks; mean± ISD) or ibuprofen-lysine i.v. treatment (IBU) 10-5-5 mg / kg at 24 hr intervals (BW: 1290 ± 400 g; GA: 29.3 ± 2.3 wks). Ductal closure, backup treatment or ligation, renal-, intestinal-, central-, hematologic and respiratory evolution were registered.

Results: PDA was closed in 37/51 (73%) in the INDO vs 39/52 (75%) in the IBU group on day 7 of life. Backup treatment and/or ligation was necessary in 7 and 5 in INDO vs 9 and 5 in IBU patients. There were no significant differences in days of ventilation (12± 9 vs 13 ± 14), days on supplemental oxygen (28± 25 vs 30 ± 33), number of deaths (4 vs 5), days to regain BW (20 ± 2 vs 21 ± 2), days to full enteral feeding (28 ± 15 vs 29 ± 14), number of intraventricular hemorrhages all grades (7 vs 7) for INDO vs IBU groups respectively. There was a trend to lower urine production (days 3-5) and higher serum creatinine values (days 5-8) in the INDO group.

Conclusion: Early ibuprofen treatment for PDA in preterm infants with RDS on day 3 of life is as efficient and without increased adverse effects, as compared to indomethacin.