NCT02422966.

Trial name or title	Efficacy and safety of paracetamol in comparison to ibuprofen for Patent Ductus Arteriosus treatment in preterm infants: A randomised, open label, comparator‐controlled, prospective study.
Methods	Randomised open label controlled trial with parallel assignment
Participants	Male or female preterm infants with no limitation of race. PMA 25(+ 0) to 31(+ 6) weeks. Age 24 to 72 h. Echocardiographic evidence of haemodynamically significant patent ductus arteriosus at the first 24 to 72 h of life. The diagnosis of haemodynamically significant PDA requiring treatment will be made by echocardiographic demonstration of a ductal left‐to‐right shunt, with a left atrium‐to‐aortic root ratio > 1.3 or a ductal size > 1.5 mm and excluding the cases in which the closing flow pattern suggests a restrictive PDA. Willingness of the parents/legally authorized representative to sign the Consent Informed Form.
Interventions	Paracetamol IV solution 15 mg/kg (corresponding to 1.5 mL/kg) per dose every 6 h for 3 days, for a total amount of 12 doses Active Comparator: ibuprofen IV solution at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 5 mg/kg at 48 h intervention
Outcomes	Success rate in closing PDA using paracetamol in comparison to ibuprofen. Incidence of surgical ligation, death, sepsis, renal failure, liver failure, gastrointestinal complications, length of stay in the NICU
Starting date	December 2015
Contact information	Paola Lipone (p.lipone@angelini.it) and Alessandra Del Vecchio (a.delvecchio@angelini.it)
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