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? |