Mosca 1997

Methods	Single centre, randomised, controlled trial conducted in Milan, Italy. Study period: not stated
Participants	16 infants receiving mechanical ventilation (< 31 weeks' GA) with ECHO evidence of PDA were randomised Ibuprofen: 8 neonates, median and range GA 29 (27 to 31) weeks, BW 855 (620 to 1620) grams , postnatal age 24 (10 to 53) hours, 4 boys, 4 girls Indomethacin: 8 neonates, median and range GA 28 (25 to 300) weeks, BW 820 (600 to 1390) grams, postnatal age 29 (5 to 120) hours, 5 boys, 3 girls
Interventions	Ibuprofen: IV 10 mg/kg infused over 1 minute as a first dose and a second and third dose administered at 24‐hour intervals provided that no significant adverse effect was observed Indomethacin: IV 0.2 mg/kg infused over 1 minute and a second and third dose of 0.1 mg/kg were administered at 24‐hour intervals provided no significant adverse effects were observed
Outcomes	PDA closure, cerebral blood flow velocity, near‐infrared spectroscopy was used to measure changes in cerebral blood volume and in oxidised cytochrome oxidase concentration
Notes	The results of this study were reported in abstract form with the same number of infants enrolled (Mosca 1996). Whether there was any overlap with an additional study was unclear (Mosca 1997a) 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	The infants were randomised. No other information provided
Blinding of participants and personnel (performance bias) All outcomes	High risk	Clinicians were aware of group assignments
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