A prospective randomized controlled trial of immunoglobulin plus prednisolone for Kawasaki disease patients with high risk for coronary abnormalities
Phase 3
- Conditions
- Kawasaki disease
- Registration Number
- JPRN-UMIN000009524
- Lead Sponsor
- agoya University Graduate School of Medicine, Department of Pediatrics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
Not provided
Exclusion Criteria
1.Patients with past histories of Kawasaki disease 2.Patients diagnosed as Kawasaki disease on the ninth day of illness or later. 3.Kawasaki disease patients with coronary artery lesions before treatment 4.Kawasaki disease patients with defervescence before treatment 5.Patients given steroids within 28 days before treatment 6.Patients given IVIG within 180 days before treatment 7.Patients with severe underlining diseases 8.Patients with bacterial infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of coronary artery lesions within 4 weeks after primary treatment
- Secondary Outcome Measures
Name Time Method Incidence of coronary artery lesions at 4 weeks after primary treatment, Z score of coronary artery diameters, incidence of resistance to primary treatment or relapse, duration of fever after primary treatment, serum concentrations of C-reactive protein at 1 week and 2 weeks after primary treatment, and incidence of adverse events