Comparison of ibuprofen and indomethacin for early-targeted treatment of patent ductus arteriosus in extremely premature infants: A randomized controlled trial

Abstract

Objective: To date there is no firm conclusion as to the efficacy and safety of ibuprofen compared with indomethacin for patent ductus arteriosus (PDA) closure in extremely premature infants. We conducted a randomized controlled trial to better address this issue.

Methods: One hundred and nineteen infants (gestational age ≤ 28 weeks) with respiratory distress syndrome and PDA confirmed by echocardiography were randomly assigned to receive either indomethacin (0.2 mg/kg) or ibuprofen (10 mg/kg), starting at < 24 h of life, followed by doses of half the first dose 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 in infants given ibuprofen, and 52/59 (88.1 %) and 1.9 ± 1.7 in infants given indomethacin. There was no significant difference 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 indomethacin 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 indomethacin for the early-targeted PDA treatment in extremely premature infants, without increasing the incidence of complications. Using our echocardiographic PDA flow pattern as a guide for PDA treatment, we used fewer doses of drugs to achieve acceptable closing rates.