Fesharaki 2012

Methods	Randomised controlled clinical trial in NICU of Vali‐ye‐Asr Hospital, Tehran, Iran. Study period 1387 to 1389 years (Shia calendar).
Participants	60 infants with ECHO‐confirmed PDA, PMA from 29 weeks to 35 weeks six days at birth, birth weight between 1000 to 2500g, age 72 hours to 120 hours and presence of a PDA confirmed by ECHO
Interventions	Oral loading dose ibuprofen: 10 mg/kg on first day, followed by 2 doses of 5 mg/kg in the next 2 days Oral loading dose ibuprofen: 15 mg/kg on first day followed by 2 doses of 7.5 mg/kg in next 2 days
Outcomes	PDA closure rates, high BUN and creatinine (levels not provided), urine output < 0.5 mL/kg after onset of treatment and gastrointestinal bleed
Notes	30 (100%) infants in 15‐mg/kg group and 23 (76.7%) infants in 10 mg/kg group had successful PDA closure with no need for surgery (P value = 0.011) Dr. Fatemeh Nayeri (corresponding author) kindly provided us with an English translation of the article in January 2013. We are still awaiting some clarifications regarding the trial. In email dated 24 May 2014, we asked for clarification regarding how the randomisation sequence was generated and how the infants were allocated to 1 of the 2 groups. We asked if it was possible for the investigators and the clinicians to determine the difference between the 2 dosing regimens? As of 17 August 2014, we have not received a response Article in Persian. No information on funding provided
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information provided regarding sequence generation
Allocation concealment (selection bias)	Unclear risk	"...divided into two groups of 30 by randomisation"
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No information provided
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information provided
Incomplete outcome data (attrition bias) All outcomes	Low risk	Outcome data provided for all 60 randomised infants
Selective reporting (reporting bias)	Unclear risk	The protocol was not available to us, so we could not judge if there were any deviations
Other bias	Low risk	Appeared free of other bias