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. 2018 Sep 28;2018(9):CD003481. doi: 10.1002/14651858.CD003481.pub7
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
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
Outcomes Primary outcome: mesenteric and renal blood flow velocity
Secondary outcomes: ductal closure, ductal reopening, and NEC
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