Chotigeat 2003.
Methods | Single centre, randomised, controlled trial conducted in Bangkok, Thailand. Study period: 1 January 2001 to 31 May 2002 | |
Participants | 30 preterm infants (GA ≤ 35 weeks, postnatal age ≤ 10 days) with an ECHO‐confirmed PDA Ibuprofen: 15 infants, mean (SD) GA 30.8 (2.3) weeks; BW 1412 (354) grams Indomethacin: 15 infants, mean (SD) GA 29.9 (2.9) weeks; BW 1434 (421) grams |
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Interventions | Ibuprofen: orally as a 3‐day treatment course every 24 hours Indomethacin: IV at 12‐hour intervals The doses of ibuprofen and indomethacin were not stated |
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Outcomes | PDA closure, need for surgical ligation, NEC | |
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) | Unclear risk | The infants were assigned to treatment group by random number |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Ibuprofen was given orally and indomethacin was given IV |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Ibuprofen was given orally and indomethacin was given IV. It is not stated that ECHOs were conducted by physicians blinded to the treatment the infant received |
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 and we could not ascertain whether there were deviations from the protocol |
Other bias | Low risk | Appeared free of other bias |