Rethinking Acetaminophen in the NICU
Prophylactic treatment closed the ductus arteriosus faster but did not reduce mortality or severe morbidity in extremely premature infants
A phase 3 randomized clinical trial, the TREOCAPA trial, assessed the efficacy of prophylactic intravenous acetaminophen in extremely preterm infants, focusing on its impact on ductus arteriosus closure and long-term survival without severe morbidity. Conducted across 43 neonatal intensive care units in 14 European countries, the study involved 778 infants and found that while acetaminophen accelerated ductus closure, it did not improve survival rates or reduce severe morbidity. Notably, cholestasis was more frequent in the acetaminophen group, raising safety concerns.
1. TREOCAPA trial involved 778 preterm infants across 43 NICUs. 2. Acetaminophen accelerated ductus arteriosus closure but did not improve survival rates. 3. Cholestasis rates were higher in acetaminophen group (6% vs 3%). 4. No significant difference in severe morbidities between groups. 5. Trial highlights the safety issues of acetaminophen use in very preterm infants.