Su 2008

Methods	Single centre, randomised controlled trial conducted in Taichung, Taiwan. Study period: February 2004 to October 2006
Participants	119 infants with ECHO evidence of a significant PDA Ibuprofen: 60 infants, median (range) PMA 25 (23 to 28) weeks; BW 825 (550 to 990) grams Indomethacin: 59 infants, median (range) PMA 25 (23 to 28) weeks; BW 762 (540 to 980) grams
Interventions	Ibuprofen: IV 10 mg/kg initially followed by 5 mg/kg at 24‐hour intervals Indomethacin: IV 0.2 mg/kg as the initial dose and then 0.1 mg/kg in infants < 48 hours old, 0.2 mg/kg in infants > 48 hours at 24‐hour intervals as indicated by PDA flow pattern
Outcomes	Primary outcome: PDA closure Secondary outcomes: need for surgical ligation, mortality within 30 days, NEC, CLD at 36 weeks' GA, IVH, PVL, ROP, BPD at 36 weeks' PMA, oliguria, post‐treatment serum creatinine, hospital stay, duration of mechanical ventilation, days to full enteral feeds, and gastric bleeding
Notes	Study included a sample size calculation. No information on funding provided
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	According to a random number table sequence, which had been prepared by a study assistant who was not involved in the care of infants
Allocation concealment (selection bias)	Low risk	The attending doctors were unaware of the drug used
Blinding of participants and personnel (performance bias) All outcomes	Low risk	The attending doctors were unaware of the drug used
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The attending doctors were unaware of the drug used
Incomplete outcome data (attrition bias) All outcomes	Low risk	There was complete follow‐up
Selective reporting (reporting bias)	Unclear risk	Study protocol was not available to us so we could not ascertain if there were deviations from the protocol
Other bias	Low risk	Appeared free of other bias