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. 2020 Feb 11;2020(2):CD003481. doi: 10.1002/14651858.CD003481.pub8

Fakhraee 2007.

Methods Single centre randomised controlled trial in Tehran, Iran. Study period: June 2003 to June 2004
Participants 36 preterm infants PMA < 34 weeks, aged ≤ 14 days, platelet count > 100,000/μL, serum creatinine ≤ 1.6 mg/dL, absence of clinical manifestations of abnormal clotting function, absence of grades III‐IV IVH. Colour Doppler ECHO evidence of significant PDA
Ibuprofen: 18 infants, mean (SD) PMA 31.5 (1.4) weeks; BW 1658 (387) grams
Indomethacin: 18 infants, mean (SD) PMA 30.9 (2.0) weeks; BW 1522 (358) grams
Study period: June 2003 to June 2004
Interventions Ibuprofen: orally as a suspension at a first dose of 10 mg/kg, followed at an interval of 24 hours by 2 doses of 5 mg/kg
Indomethacin: orally 3 times at 0.2 mg/kg/dose at intervals of 24 hours
Outcomes Ductal closure, need for re‐treatment, reopening of the duct, mortality during the first 30 days of life, maximum serum BUN and creatinine levels, NEC, IVH (grades III‐IV), oliguria
Notes No information on funding provided
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No description provided
Allocation concealment (selection bias) Unclear risk No description provided. "The enrolled patients randomly received either oral ibuprofen or oral indomethacin"
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No information provided
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk ECHOs were performed by a paediatric cardiologist, who was blinded to the infants' treatment
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Outcomes were reported for all enrolled 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