Methods | Single centre, randomised controlled trial, conducted in Firenze, Italy. Study period: not stated | |
Participants | 17 preterm infants (< 33 weeks' GA) Ibuprofen: 9 infants, mean (SD) GA 29.1 (2.2) weeks; BW 1151 (426) grams Indomethacin: 8 infants, mean (SD) GA 29.5 (2.6) weeks; BW 1277 (440) grams |
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Interventions | Ibuprofen: 10 mg/kg given as a continuous infusion over 15 minutes Indomethacin: 0.2 mg/kg as a continuous infusion over 15 minutes Regardless of ductal closure after the first dose, all infants received a second and third dose of indomethacin (0.1 mg/kg) or ibuprofen (5 mg/kg) at 24‐hour intervals |
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Outcomes | Primary outcome: mesenteric and renal blood flow velocity Secondary outcomes: ductal closure, ductal reopening, and NEC |
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Notes | 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 | Infants were randomly assigned ‐ no further information provided |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Infants were randomly assigned to receive either IV ibuprofen or IV indomethacin infusions over 15 minutes (see Interventions) |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | It was not stated whether the cardiologist performing the ECHOs was blinded to the treatments or not |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes reported on 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 |