Landmark Series
BeNeDuctus + Baby-OSCAR: treat the PDA early?
Two trials tested early ibuprofen for the patent ductus arteriosus in extremely preterm infants. Neither found the benefit many expected.
Source: Hundscheid T, et al. N Engl J Med. 2023 · Gupta S, et al. N Engl J Med. 2024.
The question
In extremely preterm infants with a patent ductus arteriosus (PDA), does early ibuprofen improve outcomes compared with waiting or placebo?
The study
- BeNeDuctus: multicenter noninferiority trial. 273 infants born before 28 weeks with an echo-confirmed PDA (>1.5 mm, left-to-right shunt) were randomized to expectant management or early ibuprofen. Primary outcome: NEC, moderate–severe BPD, or death at 36 weeks' postmenstrual age.
- Baby-OSCAR: multicenter, double-blind, placebo-controlled trial of early ibuprofen (≤72 hours) for a large PDA (≥1.5 mm with pulsatile flow) in 653 infants born at 23+0 to 28+6 weeks. Primary outcome: death or moderate–severe BPD at 36 weeks.
What they found
46.3% vs 63.5%BeNeDuctus primary outcome, expectant vs ibuprofen
69.2% vs 63.5%Baby-OSCAR primary outcome, ibuprofen vs placebo
49% vs 49%BeNeDuctus survival without NDI at 24 months
- BeNeDuctus: the primary outcome occurred in 46.3% with expectant management vs 63.5% with early ibuprofen, so expectant management was noninferior. BPD was lower with expectant management (33.3% vs 50.9%). NEC (17.6% vs 15.3%) and death (14.0% vs 18.2%) did not differ significantly.
- BeNeDuctus at 24 months: survival without neurodevelopmental impairment was 49% in both groups (RR 1.00; 95% CI 0.76–1.33).
- Baby-OSCAR: death or moderate–severe BPD occurred in 69.2% with ibuprofen vs 63.5% with placebo (adjusted RR 1.09; 95% CI 0.98–1.20). Early ibuprofen did not lower the risk.
Where the evidence stops
- Both trials tested early treatment in a specific window and population. Neither shows that no PDA should ever be treated.
- BeNeDuctus was designed to show noninferiority of waiting. Its 24-month analysis had primary-outcome data for 200 of the 234 children followed up.
- Entry criteria (ductal size, timing, echo definitions) differed between the trials, so they answer related but not identical questions.
References
- Hundscheid T, Onland W, Kooi EMW, et al. Expectant Management or Early Ibuprofen for Patent Ductus Arteriosus. N Engl J Med. 2023;388(11):980–990. doi:10.1056/NEJMoa2207418 · PubMed 36477458
- Apers WMJ, Hundscheid T, Kooi EMW, et al. Long-Term Outcomes of Expectant Management versus Early Ibuprofen for Patent Ductus Arteriosus: 24-Month Follow-Up of the BeNeDuctus Trial. J Pediatr. 2026;299:115292. doi:10.1016/j.jpeds.2026.115292 · PubMed 42637114
- Gupta S, Subhedar NV, Bell JL, et al. Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen. N Engl J Med. 2024;390(4):314–325. doi:10.1056/NEJMoa2305582 · PubMed 38265644
Independent educational content, not medical advice. Not affiliated with or endorsed by the AAP. Summaries reflect the published papers; read the originals before changing practice.
