Effectiveness of Paracetamol in Treating Hemodynamically Significant Patent Ductus Arteriosus in Preterm Newborns

Abstract

Background: Patent ductus arteriosus (PDA) is a common condition in preterm infants, often requiring medical intervention for closure. Traditional treatments such as indomethacin and ibuprofen are associated with adverse effects, prompting the exploration of alternative therapies. Paracetamol (acetaminophen) has emerged as a potential alternative with a favorable safety profile, but its efficacy in preterm infants remains under investigation.

Aim: The aim of this study is to evaluate the efficacy of paracetamol in the management of hemodynamically significant PDA in preterm newborns, focusing on ductal closure rates, respiratory improvement, and the need for further interventions.

Methods: This prospective observational study was conducted at Jawaharlal Nehru Medical College & Hospital, enrolling 50 preterm infants diagnosed with hemodynamically significant PDA. Paracetamol (15 mg/kg iv every 6 hours) was administered for 120 hours. Clinical outcomes, including PDA closure, respiratory status, and the need for additional treatments, were monitored. Data were analyzed using SPSS version 23.0.

Results: Out of 50 infants, 35 (70%) achieved complete PDA closure after 120 hours of paracetamol therapy. Respiratory improvement was observed in 28 (56%) infants, with a reduction in oxygen requirements. The mean duration of paracetamol treatment was 4.8 ± 0.9 days, and the mean NICU stay was 14.3 ± 3.2 days. No severe adverse events were noted, though 3 (6%) infants experienced mild transient liver enzyme elevation.

Conclusion: Paracetamol was found to be an effective treatment for PDA in preterm infants, with high closure rates and a favorable safety profile compared to traditional treatments. It may serve as a viable alternative to indomethacin or surgical ligation in managing PDA.

Recommendations: Paracetamol should be considered as a first-line pharmacological treatment for PDA in preterm infants, particularly in cases where traditional treatments are contraindicated or carry a high risk of adverse effects. Further studies with larger cohorts are needed to confirm these findings and assess long-term outcomes.

Keywords: Paracetamol, Patent Ductus Arteriosus, Preterm Infants, Pharmacological Treatment, Neonatal Care.