Supapannachart 2002.
Methods | Single centre, randomised, controlled trial conducted in Bangkok, Thailand. Study period: 1 April 2000 to 31 August 2001 | |
Participants | 18 preterm infants (< 34 weeks' GA) with symptomatic PDA Ibuprofen: 9 infants, mean (SD) GA 30.1 (2.7); BW 1447 (39) g; 8 boys, 1 girl Indomethacin: 9 infants, mean (SD) GA 30.4 (2.6); BW 1432 (531) g; 6 boys, 3 girls |
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Interventions | Ibuprofen: orally 10 mg/kg/dose for 3 doses at 24‐hour intervals Indomethacin: oral or IV 0.2 mg/kg/dose for 3 doses given at 12‐hour intervals |
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Outcomes | PDA closure rate, duration of ventilatory support, CLD (age not stated), IVH (grade not stated), NEC, and mortality | |
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) | Low risk | Sealed envelopes were used for allocation |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Ibuprofen and indomethacin were given at different times |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Ibuprofen and indomethacin were given at different times |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes reported for all infants randomised |
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 |