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

Aly 2007.

Methods Single centre, randomised controlled trial conducted in Cairo, Egypt. Study period: not stated
Participants 21 preterm infants (< 35 weeks' gestation) aged 2 to 7 days with respiratory distress and PDA diagnosed by Doppler ECHO
Ibuprofen (oral): 12 infants, mean (SD) GA 31.2 (2.5) weeks; BW 1521 (398) grams; 8 boys, 4 girls
Indomethacin (IV): 9 infants, mean (SD) GA 32.9 (1.6) weeks; BW 1884 (485) grams; 4 boys, 5 girls
Interventions Ibuprofen: initial oral dose of 10 mg/kg, followed by 2 doses orally of 5 mg/kg after 24 and 48 hours
Indomethacin: IV as 3 doses of 0.2 mg/kg at 12‐hour intervals
Outcomes Primary outcome: ductal closure
Secondary outcomes: biochemical tests (serum creatinine), pulmonary haemorrhage, gastrointestinal bleed, NEC, gastrointestinal perforation, and increase in serum creatinine following treatment
Notes No information about funding of the study
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No description provided
Allocation concealment (selection bias) Low risk Sealed opaque envelopes were used for random assignment
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Ibuprofen was given orally, whereas indomethacin was given IV. Ibuprofen and indomethacin were given at different time points
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Ibuprofen was given orally, whereas indomethacin was given IV. Ibuprofen and indomethacin were given at different time points. ECHOs were performed by an experienced paediatric cardiologist, and it is stated that he was blinded to the treatments
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Outcomes reported for 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