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Prophylactic Treatment of Patent Ductus Arteriosus With Acetaminophen: A Randomized Clinical Trial - PubMed

7 days ago
  • #neonatology
  • #acetaminophen
  • #clinical trial
  • Prophylactic intravenous acetaminophen was evaluated for treating patent ductus arteriosus (PDA) in extremely preterm infants.
  • The study was a double-blind, randomized, placebo-controlled trial conducted in 43 neonatal intensive care units across 14 European countries.
  • Infants born between 23 and 28 weeks' gestation received either acetaminophen or placebo within 12 hours of birth.
  • The primary outcome was survival without neonatal severe morbidities at 36 weeks' postmenstrual age, which showed no significant difference between groups (66.2% acetaminophen vs. 63.6% placebo).
  • Secondary outcome showed higher ductus arteriosus closure rates in the acetaminophen group (71.2%) compared to placebo (52.2%).
  • Adverse events were similar between groups, except for a higher cholestasis rate in the acetaminophen group (6.4% vs. 2.6%).
  • The study concluded that prophylactic acetaminophen did not increase survival without neonatal morbidities.