Efficacy and safety of oral paracetamol versus intravenous paracetamol in preterm infants with patent ductus arteriosus: a randomised controlled trial.

Abstract

Introduction: Despite the widespread use of paracetamol for ductus arteriosus closure in preterm infants, direct comparisons between oral and intravenous paracetamol remain limited. This study aimed to evaluate the efficacy and safety of oral versus intravenous paracetamol for the pharmacological closure of haemodynamically significant patent ductus arteriosus in preterm infants.

Methods: A randomised controlled trial was conducted at the neonatal intensive care unit of Hospital Pakar Universiti Sains Malaysia from January 2023 to July 2024. Fifty preterm infants (26 weeks to 33 + 6 weeks gestational age) diagnosed with haemodynamically significant patent ductus arteriosus were randomised to receive either oral or intravenous paracetamol (15 mg/kg every 6 h for 3 days). A second course was administered if the initial treatment failed. The primary outcome was complete ductal closure; secondary outcomes included renal and hepatic function, early complications and late neonatal morbidities over a 30-day follow-up period.

Results: Baseline characteristics were comparable between groups. Ductal closure was significantly higher with intravenous paracetamol than with oral paracetamol (92.6% vs. 69.6%; P = 0.035). The intravenous group also demonstrated greater reduction in ductal size (1.81 mm vs. 1.34 mm; P = 0.018). No significant differences were observed in early or late complications between groups. Both administration routes showed favourable safety profiles without serious adverse effects.

Conclusion: This study found that intravenous paracetamol had superior efficacy compared with oral administration in achieving ductal closure in preterm infants while maintaining a similar safety profile.