EUCTR2013‐003883‐30‐IT

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 of paracetamol versus ibuprofen
Participants	Preterm newborn infants (< 37 weeks' PMA)
Interventions	Paracetamol and ibuprofen
Outcomes	Primary end‐point: success rate in closing PDA using paracetamol in comparison to ibuprofen after the first 3 days of treatment. Secondary endpoints: number of re‐openings at 30 days; success rate in closing PDA after the second treatment course of ibuprofen as rescue medication; success rate of closing PDA after the first day and the second day of the first treatment course; incidence of surgical ligation at 30 days; incidence of renal failure, liver failure, gastrointestinal complications (including isolated intestinal perforation) at 30 days; incidence of death at 30 days and at 40 weeks' post conception; incidence of sepsis at 30 days; hospital‐stay duration in Neonatal Intensive Care Unit; occurrence of adverse events at 30 days
Starting date	November 2013
Contact information	Name of Sponsor: Aziende Chimiche Riunite Angelini Francesco ACRAF S.p.A, Italy
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