CTRI/2017/10/010012

Trial name or title	Randomised controlled trial of 2 different doses of intravenous paracetamol for PDA closure in preterm infants less than 30 weeks
Methods	Randomised controlled trial (computer‐generated randomisation; sequentially numbered, sealed, opaque envelopes; participant, investigator and outcome assessor blinded)
Participants	Preterm infants with a) PMA < 28 weeks or b) between 28 and 30 weeks on invasive mechanical ventilation or on CPAP with FiO₂ requirements more than 35% AND having 2D echocardiographic evidence of haemodynamically significant PDA (duct size more than 1.5 mm narrowest internal diameter, left atrium/aorta ratio more than 1.5, left to right flow across shunt, reversal of flow in distal aorta diagnosed at 18 to 24 h of life. Postnatal age 0 to 3 days
Interventions	Higher dose paracetamol group: this group will receive intravenous paracetamol in dosage of 15 mg/kg/dose 4 times a day for 5 days Lower dose paracetamol group: This group will receive intravenous paracetamol in dosage of 10 mg/kg/dose 4 times a day for 3 days
Outcomes	Primary outcome: PDA closure rate in low dose and high dose paracetamol group. PDA closure is defined as absence of flow through the ductus Secondary outcomes: all‐cause mortality, BPD, duct reopening rate, duration of hospital stay, IVH, NEC, days on assisted ventilation and oxygen therapy, PVL, rate of adverse effects (increased serum creatinine (more than 1 mg%), oliguria (urine output less than 0.5 mL/kg/h for 6 h), increased transaminases level (more than 2 × ULN), thrombocytopenia (platelet count less than 100,000/mm³), gastrointestinal haemorrhage), requirement of ibuprofen/indomethacin, requirement of multiple courses/higher doses, ROP requiring treatment (injection Avastin or laser) and surgical ligation rate.
Starting date	December 2017
Contact information	Dr Vaibhav Jain, Department of Neonatology, Surya Childrens Medicare, Mumbai (Suburban), Maharashtra, India (vaibhavjain100989@gmail.com)
Notes	Paracetamol will be given for different lengths of time — 5 days and 3 days. How will staff be blinded to the 2 treatment regimens?