Comparative Efficacy and Safety of Oral versus Intravenous Acetaminophen in Preterm Neonates with Patent Ductus Arteriosus: A Randomized Controlled Trial

Abstract

Objectives: This study aimed to compare the efficacy and safety of oral versus intravenous acetaminophen in achieving ductal closure among preterm neonates with hemodynamically significant PDA. Methodology: In this randomized, double-blind controlled trial, 60 preterm neonates with echocardiographically confirmed PDA were randomly assigned to receive either oral acetaminophen (n=30) or intravenous acetaminophen (n=30), at a dosage of 15 mg/kg every 6 hours for 3 days. A second treatment course was given if PDA persisted. The primary outcome was ductal closure rate; secondary outcomes included adverse events, clinical symptoms, and echocardiographic parameters. Results: After the first treatment course, closure occurred in 86.7% of the oral group and 90% of the intravenous group (p=0.500). Following a second course, all infants in both groups achieved complete closure. No significant differences were observed in ductal diameter reduction, time to closure, or hospital stay between groups (p>0.05). Adverse effects were infrequent (10% oral vs. 6.7% IV; p=0.500), and no severe complications were reported. Conclusion: Oral acetaminophen was found to be equivalent to intravenous acetaminophen in achieving PDA closure, with comparable safety profiles. Given its cost-effectiveness and accessibility, oral acetaminophen may represent a viable first-line alternative for managing PDA in premature neonates.