Enteral paracetamol or Intravenous Indomethacin for Closure of Patent Ductus Arteriosus in Preterm Neonates: A Randomized Controlled Trial.

ABSTRACT

Objective: To compare the efficacy of enteral paracetamol and intravenous indomethacin for closure of patent ductus arteriosus (PDA) in preterm neonates. Design: Randomized controlled trial. Setting: Level III neonatal intensive care unit. Participants: 77 preterm neonates with birth weight ≤1500 g and PDA size ≥1.5 mm, with left to right ductal flow with left atrium to aortic root ratio >1.51; diagnosed by 2D-Echo within first 48 hours of life. Intervention Paracetamol drops through the infant feeding tube (15mg/kg/dose 6 hourly for 7 days) or intravenous indomethacin (0.2 mg/kg/dose once daily for 3 days). Outcome measures: Primary PDA closure rate assessed by echocardiography. Secondary need for surgical closure of PDA, renal impairment, gastrointestinal bleed, necrotising enterocolitis, hepatotoxicity, pulmonary hemorrhage, sepsis, hypothermia, retinopathy of prematurity, intraventricular hemorrhage, bronchopulmonary dysplasia and mortality. Results: PDA closure rate was 100% (36/36) in enteral paracetamol group as compared to 94.6% (35/37) in intravenous indomethacin group (P=0.13). The secondary outcomes were also similar between the two groups. There was no occurrence of hepatotoxicity. Conclusions: Enteral paracetamol is safe but not superior to intravenous indomethacin in the treatment of PDA in preterm neonates.