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. 2018 Sep 28;2018(9):CD003481. doi: 10.1002/14651858.CD003481.pub7
Methods Single centre, randomised, controlled trial, conducted in Jerusalem, Israel. Study period: February 2002 to December 2006
Participants 64 preterm (PMA ≤ 33 weeks, BW ≤ 1750 grams) infants with PDA
Interventions Ibuprofen: 32 infants, ibuprofen 10 mg/kg IV followed by 2 doses of 5 mg/kg at 24‐hour intervals
Indomethacin: 31 infants, continuous IV infusion of indomethacin for 36 hours at a rate of 17 μg/kg/hour
Outcomes Ductal closure, need for surgical ligation, need for re‐treatment with either indomethacin or ibuprofen, need for surgical treatment, mortality, BPD (age not stated), IVH (grades III‐IV), ROP, and NEC
Notes The outcomes of BPD (age not stated), NEC, IVH (III‐IV) and ROP (3‐4) were reported in graphic form only and the numbers had to be estimated from the graph. No information on funding provided
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was based on computer‐generated random numbers without sub stratification
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) All outcomes High risk Because the methods of drug administration were clearly different, the study could not be blinded
Blinding of outcome assessment (detection bias) All outcomes Low risk The cardiologist performing the ECHOs was blinded to study group
Incomplete outcome data (attrition bias) All outcomes Low risk 1 infant assigned to the ibuprofen group was withdrawn by his parents before he started therapy, and he was not included in the analyses
Selective reporting (reporting bias) Low risk The protocol was available to us. Trial registration # NCT00485160. There were no deviations from the protocol
Other bias Low risk Appeared free of other bias