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

Pourarian 2008.

Methods One centre, randomised controlled trial, conducted in Shiraz, Republic of Iran. Study period: a 6‐month period in 2001
Participants 20 preterm infants with ECHO‐confirmed PDA
Ibuprofen: 10 infants, mean (SD) PMA 31.3 (4.4) weeks; BW 1860 (402) grams
Indomethacin: 10 infants, mean (SD) PMA 33.2 (3.1) weeks; BW 1720 (630) grams
Interventions Ibuprofen: oral suspension containing 100 mg/5 mL was given as an initial dose of 10 mg/kg, followed by 2 further doses of 5 mg/kg at 24‐hour intervals
Indomethacin: powder content of an indomethacin 25 mg capsule was freshly prepared by dissolving in 25 mL distilled water. This was given orally as 0.2 mg/kg for 3 doses at 24‐hour intervals
Administration of the second or third doses of each drug was dependent on achievement of ductal closure after the initial doses
Outcomes Primary outcome: ductal closure
Secondary outcomes: need for surgical closure, NEC, change in mean serum creatinine levels before and after treatment, increase in BUN level > 14 µmol/L, and thrombocytopenia < 50,000 mm3
Notes No information on funding provided
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information provided
Allocation concealment (selection bias) High risk "As soon as the diagnosis (of PDA) was made for the 1st eligible baby, he/she was enrolled to the ibuprofen group and then the next eligible baby was assigned to the indomethacin group, and so on". This statement clearly indicated that the infants were not allocated to the two groups in a concealed manner
Blinding of participants and personnel (performance bias) 
 All outcomes High risk The researchers were aware of group assignment ‐ see allocation concealment
Blinding of outcome assessment (detection bias) 
 All outcomes High risk The researchers were aware of group assignment ‐ see allocation concealment
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Results for all randomised infants were reported
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 Study appeared free of other bias