CTRI/2017/10/009989.

Trial name or title	Efficacy and safety of oral paracetamol versus oral ibuprofen in management of patent ductus arteriosus in preterm neonates less than or equal to 34 weeks or less than or equal to 1800 g: A randomised control trial
Methods	Randomised open label controlled trial
Participants	Preterm neonates born at ≤ 34 weeks or birth weight ≤ 1800 g with haemodynamically significant PDA. Postnatal age 0 to 28 days.
Interventions	Paracetamol will be given at 15 mg/kg 8‐hourly for 3 days 3 doses ibuprofen will be given at 24 h interval at a dose of 10, 5, 5 mg/kg for neonates younger than 70 h; 14, 7, 7 mg/kg for neonates between 70 and 108 h; and 18, 9, 9 mg/kg for neonates more than 108 h
Outcomes	All‐cause mortality, duration of hospitalisation, duration of mechanical ventilation or nasal continuous positive airway pressure (nCPAP) use or duration of need for supplementary oxygen, IVH, PVL, NEC, intestinal perforation, gastrointestinal bleed, oliguria (urine output 1 mL/kg/h), acute renal failure, acute liver injury, hyperbilirubinaemia, sepsis, BPD, ROP, pulmonary haemorrhage, pulmonary hypertension.
Starting date	Not indicated
Contact information	Vivek Kumar Athwani, Room No. 47, Doctor hostel, SPS Hospitals, Sherpur Chowk, GT Road Ludhiana, Punjab, India (vathwani@gmail.com)
Notes