Van Overmeire 2000

Methods	Multicentre, randomised controlled trial without the use of a placebo conducted in 5 NICUs in Belgium (2 hospitals in Antwerp, 1 hospital each in Ghent, Bruges, and Rocourt) Study period: not stated Blinding of randomisation ‐ yes Blinding of intervention ‐ no Complete follow‐up ‐ yes Blinding of outcome measurement(s) ‐ no
Participants	148 infants with PMA 24 to 32 weeks, who had RDS and ECHO‐confirmed PDA were randomised Ibuprofen: 74 infants, mean (SD) GA 29.0 (2.3) weeks; BW 1230 (390) grams; surfactant treatment 56 Indomethacin: 74 infants, mean (SD) GA 29.0 (2.1) weeks; BW 1230 (380) grams; surfactant treatment 63
Interventions	Ibuprofen: IV 10 mg/kg as the initial dose, followed at 24‐hour intervals by 2 doses of 5 mg/kg Indomethacin: IV 0.2 mg/kg every 12 hours
Outcomes	PDA closure rate, oliguria, PDA ligation rate, mortality by 30 days, NEC, localised bowel perforation, sepsis, PVL, CLD at 28 days, time to regain BW, time to full enteral feeding
Notes	We believe this study has been reported in abstract form when 103 preterm infants were enrolled (Van Overmeire 1998), but we have not been able to verify this with the authors. 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)	Low risk	Sealed opaque envelopes were used
Blinding of participants and personnel (performance bias) All outcomes	High risk	Ibuprofen and indomethacin were given at different times
Blinding of outcome assessment (detection bias) All outcomes	Low risk	ECHOs were performed by physicians who were unaware of the infants' treatment assignments
Incomplete outcome data (attrition bias) All outcomes	Low risk	Outcomes reported for all randomised infants
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