Patel 1995.
Methods | Single centre, randomised, controlled trial without the use of a placebo in the UK. Study period: not stated | |
Participants | 33 infants with a median GA of 26 weeks (range 23 to 28) were enrolled. All infants had ECHO‐confirmed PDA | |
Interventions | Ibuprofen: 12 infants, ibuprofen 5 mg/kg Ibuprofen: 6 infants, ibuprofen 10 mg/kg Indomethacin: 15 infants, indomethacin 0.1 mg/kg The drugs were infused IV over 15 minutes |
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Outcomes | PDA closure rate, near‐infrared spectroscopy was used to observe the effect of treatment on cerebral perfusion, indicated by changes in cerebral blood volume, and cerebral mitochondrial oxygenation, determined by the change in concentration of oxidised cytochrome aa3 | |
Notes | Published as a letter to the editor. This study was supported by the British Heart Foundation and Hammamatsu Photonics KK | |
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 | High risk | The intervention was not blinded to caregivers |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The intervention was not blinded to outcome assessors |
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 |