Trial name or title | Comparison of oral paracetamol versus ibuprofen for PDA closure in preterms – a randomised controlled single blinded study |
Methods | Randomised, parallel group trial |
Participants | Preterm neonates with 1. Congestive cardiac failure 2. Mechanical ventilation 3. LA/Aortic root ratio > 1.5. 4. Postnatal age 0 to 28 days. |
Interventions | Paracetamol 15 mg/kg/dose 6‐hourly for 2 days by oral/orogastric route Ibuprofen 10 mg/kg initially followed by 5 mg/kg once daily for 2 days by oral/orogastric route |
Outcomes | Echocardiographic closure of PDA 24 h after completion of course Secondary outcomes: cardio/respiratory morbidity and mortality by 28 days, growth and neurodevelopment by 1 year of age |
Starting date | September 2014 |
Contact information | Dr. B Bharathi, Department of Neonatology, Pondicherry, India |
Notes | Trial registered retrospectively |