NCT02002741

Trial name or title	Adding paracetamol to ibuprofen for treatment of patent ductus arteriosus in preterm infants
Methods	Randomised double‐blind controlled trial
Participants	Preterm infants born at 24 to 37 weeks' PMA, diagnosis of haemodynamically significant PDA, medical staff decided to treat with ibuprofen
Interventions	Group 1: ibuprofen + paracetamol (Ibuprofen 10 mg/kg once, then 5 mg/kg twice, every 24 h for a total of 3 doses and intravenous paracetamol loading dose 20 mg/kg then 10 mg/kg every 6 h for a total of 12 doses) Group 2: ibuprofen + placebo (ibuprofen 10 mg/kg once, then 5 mg/kg twice, every 24 h for a total of 3 doses and placebo (NaCl 0.9%), intravenous, at equal volume to the paracetamol in the paracetamol arm, total of 12 doses given every 6 h)
Outcomes	Primary outcome: the incidence of patent ductus arteriosus closure 3 to 21 days after first dose of ibuprofen by echocardiography. The need for surgical ligation of PDA. Secondary outcomes: adverse effects until discharge home ‒ renal and liver function, gastrointestinal complications
Starting date	February 2014
Contact information	o_hochwald@rambam.health.gov.il
Notes	ClinicalTrials.gov identifier: NCT02002741