NCT01938261.

Trial name or title	The preterm infants' paracetamol study (PreParaS)
Methods	Randomised controlled, double‐blind trial
Participants	Preterm infants < 32 weeks' PMA
Interventions	Paracetamol infusion solution 10 mg/mL (Perfalgan®) or placebo, 0.45% saline solution. The loading dose is 20 mg/kg, and the maintenance dose 7.5 mg/kg every 6 h for 4 days
Outcomes	Primary outcome: ductus diameter mm/kg at postnatal age 5 days. Cumulative dose of morphine at postnatal age 5 days. Secondary outcomes: number of patients who received any treatment for PDA prescribed by an attending clinician, postnatal age at closure of PDA, left atrium to aorta ratio, number of apneic periods/day, cumulative NIAPAS screening score/day up to 5 days' postnatal age, duration of mechanical ventilation, long‐term morbidity diagnoses, deaths, paracetamol side effects, paracetamol serum concentrations (up to 5 days' postnatal age)
Starting date	22 August 2013
Contact information	Outi Aikio, University of Oulu, Finland; outi.aikio@ppshp.fi
Notes	ClinicalTrials.gov identifier: NCT01938261