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Background: To date there is no firm conclusion as to the efficacy and safety of ibuprofen compared with indometacin for patent ductus arteriosus (PDA) closure in extremely premature infants. Objective: To conduct a randomised controlled trial to better address this problem. Methods: 119 infants (gestational age < or =28 weeks) with respiratory distress syndrome and PDA confirmed by echocardiography were randomly assigned to receive either indometacin (0.2 mg/kg) or ibuprofen (10 mg/kg), starting at <24 hours of life, followed by half these first doses within 48 hours at 24-hour intervals if indicated by echocardiographic PDA flow pattern. Results: The PDA closure rate and the doses of drug (mean (SD)) were similar in both groups: 53/60 (88.3%) and 1.9 (1.5) mg/kg in infants given ibuprofen, and 52/59 (88.1%) and 1.9 (1.7) mg/kg in infants given indometacin. No significant difference was found in the numbers of infants requiring surgical ligation, and the levels of post-treatment serum creatinine and urea nitrogen between the two groups. Although not significantly different, more infants (9/59 (15.3%)) treated with indometacin tended to develop oliguria (<1 ml/kg/h) than those treated with ibuprofen (4/60 (6.7%)). There were no significant differences in side effects or complications between the two groups. Conclusions: Ibuprofen is as effective as indometacin for the early-targeted PDA treatment in extremely premature infants, without increasing the incidence of complications. When the echocardiographic PDA flow pattern was used as a guide for PDA treatment, fewer doses of drugs were needed to achieve acceptable closing rates. [ABSTRACT FROM AUTHOR]