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. 2020 Feb 11;2020(2):CD003481. doi: 10.1002/14651858.CD003481.pub8

Su 2003.

Methods Single centre, randomised controlled trial conducted in Taichung, Taiwan. Study period: January 2001 to December 2002
Participants 63 preterm infants with GA ≤ 32 weeks and BW ≤ 1500 grams and with ECHO evidence of a PDA were randomised between 2 and 7 days of age
Ibuprofen: 32 infants, mean (SD) GA 28.7 (2.2) weeks; BW 1134 (200) grams
Indomethacin: 31 infants, mean (SD) GA 28.2 (2.4) weeks; BW 1110 (244) grams
Interventions Ibuprofen: IV 10 mg/kg initially, followed by 5 mg/kg after 24 and 48 hours
Indomethacin: IV 0.2 mg/kg every 12 hours for 3 doses
Outcomes Rate of PDA closure, rate of reopening of the duct, mortality, gastric bleeding, IVH, PVL, NEC, BPD at 36 weeks' GA, duration of mechanical ventilation, time to full oral feeds, and length of hospital stay
Notes No information on funding provided
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information provided
Allocation concealment (selection bias) Unclear risk Patients were randomly placed into two groups
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Ibuprofen and indomethacin were administered at different times
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk ECHOs were performed by a senior paediatric attending physician, who was unaware of the infants treatment schedule
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Outcomes reported for all infants randomised
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