ISRCTN13281214

Trial name or title	Closing patent ductus arteriosus in preterm babies by using a risk‐based score
Methods	Randomised controlled trial
Participants	Preterm infants less than 29 weeks' PMA
Interventions	Infants in the intervention arm will receive intravenous Ibuprofen (5 mg/1mL) at a dose of 10 mg/kg (2 mL/kg), followed by 2 doses of 5 mg/kg (1 mL/kg) 24 hours apart administered as a short infusion over 15 minutes Infants in the control group will receive an intravenous dose of placebo (normal saline) at a volume equivalent to that in the intervention group (2 mL/kg 1st dose; 1 mL/kg 2nd & 3rd doses)
Outcomes	The patency of the ductus will be assessed 24 hours after the last ibuprofen dose using echocardiography. If the PDA remains open (PDA diameter > 1.5 mm), then a second course of ibuprofen will be given. No further doses of ibuprofen will be administered The patency of the ductus will be assessed 24 hours after the last placebo dose using echocardiography. If the PDA remains open (defined as any identifiable flow on colour Doppler), then a second course of placebo will be given Primary outcome: chronic lung disease, defined as the need for oxygen at 36 weeks' corrected age, or death, or both, before discharge. This will be assessed prior to hospital discharge at 36 weeks' corrected age Secondary outcomes: numerous clinical and laboratory outcomes
Starting date	September 2016
Contact information	Dr Afif El‐Khuffash, Department of Neonatology, The Rotunda Hospital Dublin 1, Ireland
Notes	Overall trial end date: August 2018. Has been entered as EUCTR2015‐004526‐33‐IE too