ACTRN12613000289718.

Trial name or title	Paracetamol for patent ductus arteriosus treatment: comparison between oral and intravenous administration
Methods	Randomised controlled trial. Blinded (masking used). Researchers assessing ductal closure by ECHO will be unaware for study aims and group assignment
Participants	Neonates with PMA < 32 weeks and birth weight < 1500 g and with ECHO evidence of PDA and contraindication to or failure of conventional medical therapy with COX inhibitors (ibuprofen or indomethacin) Age 1 to 5 days
Interventions	Intravenous paracetamol at a loading dose of 20 mg/kg, followed by 7.5 mg/kg every 6 h for 7 days. If ductal closure evaluated by colour‐Doppler ultrasound occurs before the 7th day of treatment, therapy will be discontinued Paracetamol at 15 mg/kg by oral route, every 6 h for 7 days. If ductal closure evaluated by colour‐Doppler ultrasound occurs before the 7th day of treatment, therapy will be discontinued
Outcomes	Ductal closure, assessed by colour‐Doppler ultrasound at 7 days after allocation to the intervention Mortality by 42 weeks' PMA
Starting date	April 2013
Contact information	Prof Gianluca Terrin, Department of Gynecology‐Obstetrics and Perinatal Medicine, Sapienza University of Rome, Italy. (gianluca.terrin@uniroma1.it)
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