Samir Gupta, MD, from Sidra Medicine in Doha, Qatar, and colleagues conducted a multicenter, randomized, double-blind, placebo-controlled trial assessing early ibuprofen treatment (≤72 hours after birth) for a large PDA (diameter ≥1.5 mm with pulsatile flow) in extremely preterm infants. Overall, 326 and 327 infants were assigned to receive ibuprofen and placebo, respectively; 324 and 322 had data available for outcome analyses. A composite of death or moderate or severe bronchopulmonary dysplasia evaluated at 36 weeks of postmenstrual age was the primary outcome.

The researchers found that a primary outcome event occurred in 69.2 and 63.5% of infants in the ibuprofen and placebo groups, respectively (adjusted risk ratio, 1.09; 95% CI, 0.98 to 1.20; P =.10); 13.6 and 10.3 percent of infants, respectively, died (adjusted risk ratio, 1.32; 95% CI, 0.92 to 1.90). Moderate or severe bronchopulmonary dysplasia occurred in 64.2 and 59.3% of the ibuprofen and placebo groups, respectively, among the infants who survived to 36 weeks of postmenstrual age (adjusted risk ratio, 1.09; 95% CI, 0.96 to 1.23).

“Our results are broadly consistent with those of other studies of early targeted treatment of PDA with ibuprofen that have not shown a convincing benefit with respect to clinical outcomes,” the authors write.

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