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

Akisu 2001.

Methods Single centre, randomised controlled trial conducted in one NICU in Izmir, Turkey. Study period: July 1988 to January 2000
Participants 23 infants < 35 weeks' GA with ECHO‐confirmed PDA
Ibuprofen: 12 infants, mean (SD) GA 32.1 (1.2) weeks; BW 1706 (187) grams; 5 girls, 7 boys; 9 born by C/S, 2 born vaginally, 10 had RDS, 7 received surfactant. PDA was diagnosed on day 3.9 (0.5)
Indomethacin: 11 infants, mean (SD) GA 31.9 (1.3) weeks; BW 1645 (190) grams; 6 girls, 5 boys; 8 born by C/S, 3 born vaginally, 8 had RDS, 7 received surfactant. PDA diagnosed on day 3.5 (0.6)
Interventions Ibuprofen: via an oro‐gastric tube (10 mg/kg as the initial dose followed by 5 mg/kg 24 and 48 hours later)
Indomethacin: via an oro‐gastric tube (0.2 mg/kg for 3 doses at 12‐hour intervals)
2 neonates in the ibuprofen group and 3 in the indomethacin group required a second treatment with the same drug
Outcomes PDA closure; diuresis; serum creatinine; thrombocyte count; gastrointestinal haemorrhage; IVH; sepsis; mortality
Notes Study published in Turkish. No information provided about funding of the study
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Single centre, randomised controlled trial. No other information provided
Allocation concealment (selection bias) Unclear risk Allocation concealment ‐ no information provided
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Indomethacin and ibuprofen were administered at different time points
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Indomethacin and ibuprofen were administered at different time points
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