Early ibuprofen treatment may not lower risk of death, bronchopulmonary dysplasia in preterm infants with PDA
UK: Findings from the Baby-OSCAR trial revealed no evidence that early treatment with ibuprofen was associated with a lower risk of moderate or severe bronchopulmonary dysplasia or death than placebo at 36 weeks of postmenstrual age in extremely preterm infants with a large patent ductus arteriosus (PDA).
According to the study, published in The New England Journal of Medicine, Ibuprofen again failed to improve short-term outcomes when used to close PDA in newborns. The researchers argued that they at least found no evidence that ibuprofen caused serious complications.
Ibuprofen, administered parenterally a few days after infants were born prematurely, did not reduce the trial's combined primary endpoint nor its components at 36 weeks of postmenstrual age: Mortality and moderate or severe bronchopulmonary dysplasia: 69.2% vs 63.5% with placebo; mortality: 13.6% vs 10.3%; and moderate or severe bronchopulmonary dysplasia: 64.2% vs 59.3%.
The cyclooxygenase inhibitor ibuprofen ibuprofen may be used for treating PDA in preterm infants. However, it is unknown whether selective early treatment of large PDAs with ibuprofen would improve short-term outcomes. Samir Gupta, Sidra Medicine in Doha, Qatar, and colleagues aimed to evaluate early ibuprofen treatment (≤72 hours after birth) for a large patent ductus arteriosus (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 study's primary outcome was a composite of death or moderate or severe bronchopulmonary dysplasia assessed at 36 weeks of postmenstrual age. A total of 326 infants were assigned to receive ibuprofen and 327 to receive placebo; 324 and 322, respectively, had data available for outcome analyses.
The study led to the following findings:
· A primary outcome event occurred in 69.2% of infants in the ibuprofen group and 63.5% of infants in the placebo group (adjusted risk ratio, 1.09).
· 13.6% of infants in the ibuprofen group and 10.3% of infants in the placebo group died (adjusted risk ratio, 1.32).
· Among the infants who survived to 36 weeks of postmenstrual age, moderate or severe bronchopulmonary dysplasia occurred in 64.2% in the ibuprofen group and 59.3% in the placebo group (adjusted risk ratio, 1.09).
· Two unforeseeable serious adverse events occurred that were possibly related to ibuprofen.
"We did not find a significantly lower risk of death or moderate or severe bronchopulmonary dysplasia at 36 weeks of postmenstrual age among infants who received early treatment with ibuprofen than among those who received a placebo," the researchers wrote.
Reference:
Gupta S, Subhedar NV, Bell JL, Field D, Bowler U, Hutchison E, Johnson S, Kelsall W, Pepperell J, Roberts T, Sinha S, Stanbury K, Wyllie J, Hardy P, Juszczak E; Baby-OSCAR Collaborative Group. Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen. N Engl J Med. 2024 Jan 25;390(4):314-325. doi: 10.1056/NEJMoa2305582. PMID: 38265644.
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