Bada 1989.
Study characteristics | ||
Methods | Single‐centre randomized controlled trial | |
Participants |
Inclusion criteria
Exclusion criteria
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Interventions |
Active intervention (n = 71) Prophylactic IV indomethacin 0.2 mg/kg at 6 hours of age; and 0.1 mg/kg at 18 hours and 30 hours of age Control (n = 70) IV placebo (no description available) |
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Outcomes | Relevant outcomes for this study included
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Notes |
Primary study location: Regional Medical Center, Memphis, Tenessee, USA Study period: not specified Trial registration: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | It was not stated how randomization was done |
Allocation concealment (selection bias) | Unclear risk | No information provided on allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo was used suggesting personnel were blinded during the study |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Primary outcome assessed by one investigator blinded to the allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomized infants accounted for |
Selective reporting (reporting bias) | Unclear risk | No protocol available for comparison |
Other bias | Unclear risk | No specific issues noted. |