• Samir Gupta, Nimish V Subhedar, Jennifer L Bell, David Field, Ursula Bowler, Elizabeth Hutchison, Sam Johnson, Wilf Kelsall, Justine Pepperell, Tracy Roberts, Sunil Sinha, Kayleigh Stanbury, Jonathan Wyllie, Pollyanna Hardy, Edmund Juszczak, and Baby-OSCAR Collaborative Group.
• From the Division of Neonatology, Sidra Medicine, Doha, Qatar (S.G.); and the Department of Engineering, Durham University, Durham (S.G.), Liverpool Women's NHS Foundation Trust, Liverpool (N.V.S.), the National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford (J.L.B., U.B., E.H., J.P., K.S., P.H.), the Department of Health Science University of Leicester, George Davies Centre, Leicester (D.F., S.J.), NICU, Rosie Hospital, Cambridge University Hospital Foundation Trust, Cambridge (W.K.), the Institute of Applied Health Research, University of Birmingham, Birmingham (T.R.), South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Middlesbrough (S.S., J.W.), and the School of Medicine, University of Nottingham, Nottingham (E.J.) - all in the United Kingdom.
• N. Engl. J. Med. 2024 Jan 25; 390 (4): 314325314-325.

BackgroundThe cyclooxygenase inhibitor ibuprofen may be used to treat patent ductus arteriosus (PDA) in preterm infants. Whether selective early treatment of large PDAs with ibuprofen would improve short-term outcomes is not known.MethodsWe conducted a multicenter, randomized, double-blind, placebo-controlled trial evaluating early treatment (≤72 hours after birth) with ibuprofen for a large PDA (diameter of ≥1.5 mm with pulsatile flow) in extremely preterm infants (born between 23 weeks 0 days' and 28 weeks 6 days' gestation). The primary outcome was a composite of death or moderate or severe bronchopulmonary dysplasia evaluated at 36 weeks of postmenstrual age.ResultsA total of 326 infants were assigned to receive ibuprofen and 327 to receive placebo; 324 and 322, respectively, had data available for outcome analyses. A primary-outcome event occurred in 220 of 318 infants (69.2%) in the ibuprofen group and 202 of 318 infants (63.5%) in the placebo group (adjusted risk ratio, 1.09; 95% confidence interval [CI], 0.98 to 1.20; P = 0.10). A total of 44 of 323 infants (13.6%) in the ibuprofen group and 33 of 321 infants (10.3%) in the placebo group died (adjusted risk ratio, 1.32; 95% CI, 0.92 to 1.90). Among the infants who survived to 36 weeks of postmenstrual age, moderate or severe bronchopulmonary dysplasia occurred in 176 of 274 (64.2%) in the ibuprofen group and 169 of 285 (59.3%) in the placebo group (adjusted risk ratio, 1.09; 95% CI, 0.96 to 1.23). Two unforeseeable serious adverse events occurred that were possibly related to ibuprofen.ConclusionsThe risk of death or moderate or severe bronchopulmonary dysplasia at 36 weeks of postmenstrual age was not significantly lower among infants who received early treatment with ibuprofen than among those who received placebo. (Funded by the National Institute for Health Research Health Technology Assessment Programme; Baby-OSCAR ISRCTN Registry number, ISRCTN84264977.).Copyright © 2024 Massachusetts Medical Society.

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