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 |
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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 |
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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 |
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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 |