Van Overmeire 1997.
Methods | Single centre, randomised controlled trial conducted in Antwerp, Belgium Study period: not stated Blinding of randomisation ‐ yes Blinding of intervention ‐ no Complete follow‐up ‐ yes Blinding of outcome measurement(s) ‐ no |
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Participants | 40 preterm infants (GA 33 weeks) were randomised Ibuprofen: 20 infants, mean (SD) GA 29.0 (2.4) weeks; BW 1270 (450) grams; surfactant use 15 Indomethacin: 20 infants, mean (SD) GA 28.7 (1.9) weeks; BW 1210 (360) grams, surfactant use 19 |
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Interventions | Ibuprofen: IV 10 mg/kg as the initial dose followed by 5 mg/kg 24 and 48 hours later Indomethacin: IV 0.2 mg/kg every 12 hours for 3 doses Both drugs were infused over 15 minutes |
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Outcomes | PDA closure rate, PDA ligation rate, mortality, sepsis, NEC, age to regain BW, and ROP | |
Notes | It is possible that there was overlap between this study and a report in abstract form with 28 infants enrolled (Van Overmeire 1996). 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 |
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 | Unclear risk | Ibuprofen and indomethacin were given at different times. It was not stated whether the ECHOs were performed by a physician blinded to group assignment |
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 |