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) |
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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 |
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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 |