Bagnoli 2013

Methods	Single centre, randomised controlled trial conducted in Siena, Italy. Study period: January 2006 to December 2010
Participants	134 preterm newborns with ECHO‐confirmed PDA (PMA < 32 weeks, BW < 1500 grams, postnatal age > 72 hours
Interventions	Ibuprofen: 67 infants, 3‐day treatment course of ibuprofen 10 mg/kg, 5 mg/kg and 5 mg/kg given IV over 10 minutes Placebo: 67 infants, 0.9% NaCl given IV
Outcomes	Failure to close a PDA, need for surgical ligation of the PDA, oliguria, NEC, creatinine and BUN before and after treatment, mortality at 28 days of life
Notes	Dr. Annalisa Rossetti provided additional outcome data and information about the conduct of the trial that were not in the published report. No information on funding provided
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The randomisation sequence was manually generated (according to an internal protocol)
Allocation concealment (selection bias)	Unclear risk	No information provided
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	"This trial was a randomised, placebo‐controlled, double‐blind parallel design study...". No other detailed information provided
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	"This trial was a randomised, placebo‐controlled, double‐blind parallel design study...". No other detailed information provided
Incomplete outcome data (attrition bias) All outcomes	Low risk	Outcome data reported for all randomised infants
Selective reporting (reporting bias)	Unclear risk	Study protocol was not available to us so we could not judge if there were any deviations from the protocol
Other bias	Low risk	Appeared free of other bias