Anesthesiology May 2024, Vol. 140, A13–A15.
Trial of selective early treatment of patent ductus arteriosus with ibuprofen. N Engl J Med 2024; 390:314–25. PMID: 38265644.
The presence of patent ductus arteriosus in preterm infants beyond 3 days of age, particularly 1.5 mm or larger in diameter, is associated with increased risk of bronchopulmonary dysplasia and mortality. Bedside echocardiography has greatly facilitated detection of larger patent ductus arteriosus that are unlikely to close spontaneously and may be amenable to pharmacologic intervention such as cyclooxygenase inhibitors (e.g., ibuprofen or indomethacin). This multicenter (32 United Kingdom neonatal intensive care units), double-blind, placebo-controlled trial evaluated selective early treatment of large patent ductus arteriosus with ibuprofen (loading dose 10 mg/kg then two doses of 5 mg/kg 24 h apart) on short-term outcome, randomizing extremely premature infants (born between 23 weeks’ and 28 weeks’ gestation) to ibuprofen (N = 324) or placebo (N = 322). The primary outcome was a composite of death, or moderate or severe bronchopulmonary dysplasia evaluated at 36 weeks postmenstrual age. There was no difference in the composite primary outcome between groups (69.2% ibuprofen vs. 63.5% placebo; adjusted risk ratio, 1.09; 95% CI, 0.98 to 1.20; P = 0.10) nor in mortality (13.6% vs. 10.3%; adjusted risk ratio, 1.32; 95% CI, 0.92 to 1.90) or development of moderate or severe bronchopulmonary dysplasia (64.2% vs. 59.3%; adjusted risk ratio, 1.09; 95% CI, 0.96 to 1.23). Two serious adverse events occurred in the ibuprofen group.
Take home message: In this randomized multicenter trial of extremely premature infants with a large patent ductus arteriosus, mortality or moderate or severe bronchopulmonary dysplasia at 36 weeks was not significantly different with early treatment with ibuprofen versus placebo.
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