Oral indomethacin versus oral ibuprofen for treatment of patent ductus arteriosus: a randomised controlled study in very low-birthweight infants

Background: In low- and middle-income countries (LMIC), haemodynamically significant patent ductus arteriosus (hsPDA) is treated with oral indomethacin (IDC) and ibuprofen (IB) instead of intravenous formulations. No significant differences in efficacy have been reported. However, previous studies had small numbers of VLBW infants (< 1500g). Objective: To evaluate the efficacy of oral IDC and IB for closing PDA in VLBW infants with a gestational age of 24-32weeks. Methods: This randomised controlled study enrolled 32 infants with hsPDA for treatment with either three doses of oral IDC or oral IB. Echocardiography was performed before and after treatment. Results: Oral IDC was more effective than oral IB (65% vs. 27%, p = 0.03). This difference was attributable to the subset of extremely low-birthweight infants (< 1000g) in whom an hsPDA closed 78% of the time after oral IDC compared with 13% of those treated with oral IB (p = 0.01). In contrast, there was no difference in hsPDA closure rates between the study groups of infants with birthweights of 1000-1499 g. There was no significant difference between the drugs in clinical and laboratory measures of adverse effects, nor of other clinical outcomes. Conclusion: Oral IDC was more effective than oral IB for closing PDA in VLBW infants, without significant differences in side-effects or short-term outcomes.