Su 2003.
Methods | Single centre, randomised controlled trial conducted in Taichung, Taiwan. Study period: January 2001 to December 2002 | |
Participants | 63 preterm infants with GA ≤ 32 weeks and BW ≤ 1500 grams and with ECHO evidence of a PDA were randomised between 2 and 7 days of age Ibuprofen: 32 infants, mean (SD) GA 28.7 (2.2) weeks; BW 1134 (200) grams Indomethacin: 31 infants, mean (SD) GA 28.2 (2.4) weeks; BW 1110 (244) grams |
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Interventions | Ibuprofen: IV 10 mg/kg initially, followed by 5 mg/kg after 24 and 48 hours Indomethacin: IV 0.2 mg/kg every 12 hours for 3 doses |
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Outcomes | Rate of PDA closure, rate of reopening of the duct, mortality, gastric bleeding, IVH, PVL, NEC, BPD at 36 weeks' GA, duration of mechanical ventilation, time to full oral feeds, and length of hospital stay | |
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 | Patients were randomly placed into two groups |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Ibuprofen and indomethacin were administered at different times |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | ECHOs were performed by a senior paediatric attending physician, who was unaware of the infants treatment schedule |
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 |