JAMA Pediatr

Trial questions benefit of acetaminophen to close patent ductus arteriosus

February 18, 2026

In the randomized TREOCAPA trial (NCT04459117) of 778 extremely preterm infants across 43 NICUs, prophylactic IV acetaminophen started within 12 hours of birth did not increase survival without severe neonatal morbidities at 36 weeks’ postmenstrual age compared with placebo (66.2% vs. 63.6%; relative risk, 1.04, 95% confidence interval, 0.94-1.16). However, echocardiographic patent ductus arteriosus (PDA) closure by day 7 was more common with acetaminophen (71% vs. 52%). Overall adverse events were similar, though cholestasis occurred more often with acetaminophen (6.4% vs. 2.6%).

Clinical takeaway: Early acetaminophen may promote PDA closure but does not improve broader neonatal outcomes.

Source:

Rozé JC, et al; TREOCAPA Study Group. (2026, February 16). JAMA Pediatr. Prophylactic Treatment of Patent Ductus Arteriosus With Acetaminophen: A Randomized Clinical Trial. https://pubmed.ncbi.nlm.nih.gov/41697673/