Ogino 1987B.
Study characteristics | ||
Methods | Unit of randomisation: child
Method of randomisation: centrally randomised
Timing of randomisation: at diagnosis
Blinding: not stated. Clearly the patients and the treatment providers were not blinded. It is not stated if outcome assessors had any blinding
Power calculation: nil
Number of centres: 32 142 patients randomised 25 exclusions 117 patients analysed Source of funding: not stated |
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Participants | Children within 7 days of onset of illness. Diagnostic criteria were not defined. Children who had received any IVIG prior to randomisation were excluded Age: not stated. Untl at least 72 months Location: Japan Timing and duration: 1985‐1986 |
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Interventions | 400mg/kg/day of S‐Sulphonated IVIG + 30/mg/kg/day of aspirin until serum CPR became negative and then 10/mg/kg/day Control: yes (aspirin only) Duration: 3 days (IVIG), aspirin duration not stated |
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Outcomes | Coronary artery aneurysms Coronary artery dilations | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |