Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease
Kawasaki Disease
About this trial
This is an interventional treatment trial for Kawasaki Disease focused on measuring Kawasaki disease, prednisolone, coronary artery lesion
Eligibility Criteria
Inclusion Criteria:
- Meeting diagnostic criteria for Kawasaki disease (KD) released by American Heart Association (AHA) in 2017
- Diagnosed before the tenth day of illness (with the first day of illness defined as the first day of fever)
- Not treated with IVIG yet
- Age ≥1 month
Exclusion Criteria:
- Z score of any coronary artery before initial treatment ≥10
- Receiving steroids or other immunosuppressive agents in the previous 30 days
- With a previous history of KD
- Afebrile before enrolment
- With suspected infectious diseases including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella and influenza
- With serious immune diseases such as immunodeficiency or chromosomal abnormalities
Sites / Locations
- Beijing Children's HospitalRecruiting
- The First Hospital of Jilin UniversityRecruiting
- Sichuan Provincial People's HospitalRecruiting
- Chengdu Women's and Children's Central HospitalRecruiting
- Children's Hospital of Chongqing Medical UniversityRecruiting
- Hangzhou First people's HospitalRecruiting
- Inner Mongolia People's HospitalRecruiting
- Qilu Hospital of Shandong UniversityRecruiting
- Jiangxi Provincial Children's HospitalRecruiting
- Children's Hospital of Fudan UniversityRecruiting
- Shengjing Hospital of China Medical UniversityRecruiting
- Children's hospital of Soochow University
- Yuying Children's Hospital of Wenzhou Medical University
- Union Hospital,Tongji Medical College of Huazhong University of Science and TechnologyRecruiting
- The Third Affiliated Hospital of ZhengzhouUniversity
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
the standard group
the standard+prednisolone group
IVIG 2g/kg once, given within 12 to 24 hours; Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and C-reactive protein (CRP) is normal. Aspirin will be continued for at least 6 weeks after onset of illness.
IVIG 2g/kg once, given within 12 to 24 hours; Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and CRP is normal. Aspirin will be continued for at least 6 weeks after onset of illness. Intravenous methylprednisolone 1.6 mg/kg per day (given in 2 divided doses) for 3 days, then changed to oral prednisolone 2 mg/kg when fever subsides for 3 days . If CRP is normal, the oral dose will be reduced every 5 days from 2 mg/kg to 1 mg/kg to 0.5 mg/kg (tapered over 15 days). Then prednisolone will be discontinued.