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

Salama 2008.

Methods Single centre, randomised controlled trial conducted in Doha, State of Qatar. Study period: January 2005 to March 2007
Participants 41 preterm infants (PMA, 34 weeks, BW < 2500 grams) diagnosed with haemodynamically significant PDA confirmed by ECHO
Ibuprofen: 21 infants, mean (SD) PMA 27.7 (2.5); BW 1094 (480) grams
Indomethacin: 20 infants, mean (SD) PMA 27.8 (2.8) weeks; BW 1050 (440) grams
Interventions Ibuprofen: oral 10 mg/kg on the first day followed by 5 mg/kg for 2 more days. Ibuprofen was mixed with 0.5 mL of milk before its administration via an oro‐gastric tube
Indomethacin: IV 3 doses of 0.2 mg/kg/dose every 24 hours
Outcomes Primary outcome: complete closure of the PDA
Secondary outcomes: need for surgical ligation, bowel perforation, and mortality
Notes No information on funding provided
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was conducted according to a pre designed simple block randomisation table 'A' for indomethacin and 'B' for ibuprofen (AABABBBBAA, BBBAAABBA, AABBABABAAB, etc.)
Allocation concealment (selection bias) Unclear risk No description of possible concealment
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Indomethacin was given IV and ibuprofen was given via an oro‐gastric tube
Blinding of outcome assessment (detection bias) 
 All outcomes High risk "The paediatric cardiologist was aware of patient's group allocation"
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