Methods | Three centre, randomised controlled trial in 3 NICUs in the Czech Republic. Study period: not stated | |
Participants | 41 preterm infants with clinical and ECHO signs of PDA were randomised Ibuprofen: 21 infants, mean (SD) GA 27.6 (2.3) weeks; BW 929 (213) grams Indomethacin: 20 infants, mean (SD) GA 26.9 (1.7) weeks; BW 902 (211) grams |
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Interventions | Ibuprofen: IV 8 mg/kg every 24 hours for 3 doses Indomethacin: IV 0.2 mg/kg every 24 hours for 3 doses If PDA persisted, treatment was repeated at half dose every 24 hours for 6 doses. Persistent PDA was ligated |
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Outcomes | Cerebral blood flow velocities, blood pressure, serum creatinine, mortality, and ductal reopening | |
Notes | Published in abstract form only. 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 | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information provided |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow‐up ‐ yes |
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 |