ACTRN12616000195459.

Trial name or title	Early pharmacological treatment with supportive care versus supportive care alone in preterm infants with a patent ductus arteriosus
Methods	Randomised controlled trial
Participants	Preterm infants less than 29 weeks' PMA, PDA diameter > 1.5 mm, postnatal age 0 to 72 hours
Interventions	Both commonly used NSAID preparations will be eligible and can be used according to current local guidelines. The standard recommended dose and interval were Indomethacin IV 0.2‐0.1‐0.1 mg/kg with 24 hour intervals and Ibuprofen IV 10‐5‐5 mg/kg with 24 hour intervals combined with supportive care. Placebo (comparable volume as 0.9% saline in 24 hour intervals) combined with supportive care. Supportive care included optimising airway pressure, careful fluid management with or without the use of diuretics as per current standard practice. No directive guideline was provided with this study, as none of these supportive care measures have been rigorously tested.
Outcomes	Primary: composite chronic lung disease or death, or both, at 36 weeks' corrected PMA
Starting date	June 2016
Contact information	Dr Koert de Waal, John Hunter Children's Hospital, Department of Newborn Care, Lookout Road, New Lambton NSW 2305, Australia Phone +61 2 49855537. Email: koert.dewaal@hnehealth.nsw.gov.au
Notes	Anticipated date of last recruitment March 2018