THURSDAY, Jan. 25, 2024 (HealthDay News) -- For extremely preterm infants, the risk for death or moderate or severe bronchopulmonary dysplasia is not significantly lower among those receiving early treatment for patent ductus arteriosus (PDA) with ibuprofen versus placebo, according to a study published in the Jan. 25 issue of the New England Journal of Medicine.
Samir Gupta, M.D., 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 percent of infants in the ibuprofen and placebo groups, respectively (adjusted risk ratio, 1.09; 95 percent confidence interval [CI], 0.98 to 1.20; P = 0.10); 13.6 and 10.3 percent of infants, respectively, died (adjusted risk ratio, 1.32; 95 percent confidence interval, 0.92 to 1.90). Moderate or severe bronchopulmonary dysplasia occurred in 64.2 and 59.3 percent of the ibuprofen and placebo groups, respectively, among the infants who survived to 36 weeks of postmenstrual age (adjusted risk ratio, 1.09; 95 percent confidence interval, 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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