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 |
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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 |
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Outcomes | Primary outcome: complete closure of the PDA Secondary outcomes: need for surgical ligation, bowel perforation, and mortality |
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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 |