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 |
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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Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 infant assigned to the ibuprofen group was withdrawn by his parents before he started therapy, and he was not included in the analyses |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 |