A randomized trial of intravenous acetaminophen versus indomethacin for treatment of hemodynamically significant PDAs in VLBW infants.

Objective was to compare the rate of successful treatment of hsPDA based on echocardiogram criteria after use of IV acetaminophen or IV indomethacin in very low-birthweight infants. The study was a multi-center, randomized controlled trial. Infants born prior to 32 weeks with birthweight ≤ 1500 g were included if PDA treatment was indicated within the 21 days after birth. hsPDA was defined by strict echocardiogram criteria. Eligible infants were randomized to treatment with either IV acetaminophen or IV indomethacin. Of 86 eligible infants, 17 infants were randomized to acetaminophen and 20 to indomethacin. One (5.9%) hsPDA in the acetaminophen group had successful treatment compared to 11 (55%) in the indomethacin group (p = 0.002). Eight (47%) in the acetaminophen group and 3 (15%) in the indomethacin group received transcatheter PDA closure (p = 0.07). IV indomethacin was more effective than IV acetaminophen for treatment of hsPDAs. More infants in the acetaminophen group received transcatheter closure.