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

Van Overmeire 1997.

Methods Single centre, randomised controlled trial conducted in Antwerp, Belgium
Study period: not stated
Blinding of randomisation ‐ yes
Blinding of intervention ‐ no
Complete follow‐up ‐ yes
Blinding of outcome measurement(s) ‐ no
Participants 40 preterm infants (GA 33 weeks) were randomised
Ibuprofen: 20 infants, mean (SD) GA 29.0 (2.4) weeks; BW 1270 (450) grams; surfactant use 15
Indomethacin: 20 infants, mean (SD) GA 28.7 (1.9) weeks; BW 1210 (360) grams, surfactant use 19
Interventions Ibuprofen: IV 10 mg/kg as the initial dose followed by 5 mg/kg 24 and 48 hours later
Indomethacin: IV 0.2 mg/kg every 12 hours for 3 doses
Both drugs were infused over 15 minutes
Outcomes PDA closure rate, PDA ligation rate, mortality, sepsis, NEC, age to regain BW, and ROP
Notes It is possible that there was overlap between this study and a report in abstract form with 28 infants enrolled (Van Overmeire 1996). 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 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 Unclear risk Ibuprofen and indomethacin were given at different times. It was not stated whether the ECHOs were performed by a physician blinded to group assignment
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