Patent ductus arteriosus (PDA) in preterm infants is commonly managed with pharmacological agents to promote ductal closure. Although paracetamol has been increasingly used for this indication, direct comparisons between oral and intravenous paracetamol for closure of haemodynamically significant PDA are limited. The trial reported here aimed to evaluate the efficacy and safety of oral versus intravenous paracetamol for pharmacological closure of haemodynamically significant PDA in preterm infants.
This was a randomised controlled trial conducted at the neonatal intensive care unit of Hospital Pakar Universiti Sains Malaysia from January 2023 to July 2024. The study enrolled a total of 50 preterm infants with gestational ages between 26+0 and 33+6 weeks who were diagnosed with haemodynamically significant PDA. Participants were randomised to receive either oral or intravenous paracetamol. The abstract reports that baseline characteristics were comparable between groups; the abstract does not provide a detailed table of those baseline variables.
Both study arms received paracetamol at a dose of 15 mg/kg every 6 hours for 3 days. If the initial treatment failed to achieve ductal closure, a second identical course was permitted. The trial therefore compared the same dosing regimen delivered via two different routes: oral administration and intravenous administration.
The primary outcome was complete ductal closure. Secondary outcomes included change in ductal size, renal and hepatic function measures, early complications, and late neonatal morbidities assessed over a 30-day follow-up period. The abstract does not specify the precise definitions or thresholds used for renal or hepatic dysfunction, nor does it list individual late morbidities or their diagnostic criteria.
Ductal closure rates differed significantly between groups. The intravenous paracetamol group achieved complete ductal closure in 92.6% of infants compared with 69.6% in the oral paracetamol group (P = 0.035). Reduction in ductal size also favored the intravenous route: mean reduction reported was 1.81 mm with intravenous administration versus 1.34 mm with oral administration (P = 0.018). These findings indicate greater efficacy for the intravenous route both in categorical closure rates and in the magnitude of ductal size reduction.
Safety assessments reported in the abstract included renal and hepatic function, early complications, and late neonatal morbidities over 30 days. The authors state that no significant differences were observed between the oral and intravenous groups for early or late complications. Both administration routes had a favourable safety profile without serious adverse effects reported in the abstract. Specific laboratory values, incidence counts for individual complications, and statistical comparisons for the secondary safety endpoints were not provided in the abstract.
The trial authors concluded that intravenous paracetamol was more effective than oral paracetamol in achieving ductal closure in preterm infants with haemodynamically significant PDA, while maintaining a similar safety profile between routes of administration. These results support consideration of the intravenous route when maximizing efficacy for PDA closure is a priority, though the abstract does not present cost, feasibility, or resource considerations.
The abstract does not provide several details that clinicians and researchers may find relevant: the exact randomisation method, allocation concealment, number of infants in each arm, detailed baseline characteristic tables, numerical data for renal and hepatic function tests, breakdown of early and late complications by type and frequency, and any longer-term follow-up beyond 30 days. The authors do not report these details in the abstract; full-text review would be needed to evaluate methodology, subgroup analyses, and comprehensive safety data.
Note: All facts in this summary are drawn from the published abstract. Where the abstract omitted specific methodological or numerical details, that absence is stated rather than inferred.