EUCTR2015‐003177‐14‐ES.

Trial name or title	Paracetamol versus ibuprofen in preterm infants with a haemodynamically significant patent ductus arteriosus: a randomised clinical trial
Methods	Randomised double‐blind trial
Participants	Preterm infants with PMA < 30 weeks and postnatal age < 2 weeks with significant PDA diagnosed by ultrasound
Interventions	Paracetamol (IV) versus ibuprofen (IV)
Outcomes	Main objective of the trial: to compare the efficacy of the standard treatment of PDA with ibuprofen versus paracetamol in closing the patent ductus arteriosus, to determine its non‐inferiority to ibuprofen. Secondary objectives of the trial: 1. To compare the safety of both treatments by the rate of early and late complications. 2. Set the pharmacokinetics and pharmacodynamics of paracetamol in the neonatal period in infants with persistent ductus. 3. Study of biomarkers and polymorphisms in urine
Starting date	2015
Contact information	Not provided
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