Kumar 2017

Trial name or title	Oral paracetamol versus oral ibuprofen for closure of haemodynamically significant patent ductus arteriosus in preterm neonates (< 32 weeks): a blinded, randomised, active‐controlled, non‐inferiority trial
Methods	Multi‐site, randomised, active‐controlled, blinded, non‐inferiority trial
Participants	Preterm neonates of < 32 weeks’ PMA with presence of a haemodynamically significant PDA
Interventions	Paracetamol oral suspension administered through an orogastric tube in a dose of 15 mg/kg/dose at 6‐hourly intervals for 3 consecutive days Ibuprofen oral suspension (Ibugesic, Cipla India) would be administered through orogastric tubes in a dose of 10 mg/kg/dose followed by 5 mg/kg/dose after 24 and 48 h from the first dose.
Outcomes	Primary outcome: closure of PDA by the end of the last dose of the study drug or earlier, irrespective of the course of the drug Secondary outcomes: closure of PDA following a single course of study drug, closure of PDA following surgical ligation, death (due to any cause) before discharge from the hospital, reopening of PDA following initial closure, ECHO‐proven pulmonary artery hypertension, azotaemia, oliguria, hepatitis with deranged liver transaminases, deranged coagulogram, IVH (any grade of severity), severe IVH (grade 3 and intraparenchymal extension), PVL, NEC (all stages), NEC (definite and advanced stage as per modified Bell’s staging), feed intolerance, BPD and ROP
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