Harada 1991B(2).
Study characteristics | ||
Methods | Unit of randomisation: child
Method of randomisation: centralised randomisation
Timing of randomisation: at diagnosis
Blinding: unclear
Power calculation: nil
Number of centres: not stated. However the paper states "multicentre" 295 patients randomised in all 3 comparisons 6 exclusions at 30 days, 17 at 60 days and 18 at 1 year 289 patients analysed at 30 days, 278 at 60 days and 277 at a year Source of funding: not stated |
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Participants | Children within 7 days of the onset of symptoms. Diagnostic criteria not stated Age: under 4 years Location: Japan Timing and duration: 1985‐1986 |
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Interventions | 100 mg/kg/day pepsin‐treated IVIG + 50 mg/kg/day oral aspirin Control: 50 mg/kg/day oral aspirin Duration: 5 days (IVIG), aspirin duration not stated |
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Outcomes | Coronay artery abnormalities | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |