Expectant Management or Early Ibuprofen for Patent Ductus Arteriosus

This multicenter, randomized noninferiority trial (BeNeDuctus) compared expectant management versus early ibuprofen treatment in 273 extremely preterm infants (<28 weeks gestational age) with echocardiographically confirmed patent ductus arteriosus (PDA). The composite primary outcome necrotizing enterocolitis (NEC), moderate-to-severe bronchopulmonary dysplasia (BPD), or death at 36 weeks’ postmenstrual age occurred in 46.3% of the expectant-management group and 63.5% in the early-ibuprofen group, showing noninferiority for expectant management (risk difference –17.2 percentage points; P<0.001). NEC and death rates were similar between groups, while moderate-to-severe BPD occurred more frequently in the ibuprofen group. Secondary outcomes, adverse events, and subgroup analyses were consistent with these findings. The study concludes that expectant management is a viable alternative to early pharmacologic treatment, with potentially fewer adverse pulmonary outcomes.

This multicenter, randomized noninferiority trial (BeNeDuctus) compared expectant management versus early ibuprofen treatment in 273 extremely preterm infants (<28 weeks gestational age) with echocardiographically confirmed patent ductus arteriosus (PDA). The composite primary outcome necrotizing enterocolitis (NEC), moderate-to-severe bronchopulmonary dysplasia (BPD), or death at 36 weeks’ postmenstrual age occurred in 46.3% of the expectant-management group and 63.5% in the early-ibuprofen group, showing noninferiority for expectant management (risk difference –17.2 percentage points; P<0.001). NEC and death rates were similar between groups, while moderate-to-severe BPD occurred more frequently in the ibuprofen group. Secondary outcomes, adverse events, and subgroup analyses were consistent with these findings. The study concludes that expectant management is a viable alternative to early pharmacologic treatment, with potentially fewer adverse pulmonary outcomes.