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Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease
Sponsor: Children's Hospital of Fudan University
Summary
This study evaluates the efficacy of the addition of prednisolone to conventional initial treatment (intravenous immunoglobulin \[IVIG\] plus aspirin) in reducing coronary artery lesion in children with Kawasaki disease (KD) .
Official title: Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease: A Multicentre Randomised Controlled Trial
Key Details
Gender
All
Age Range
1 Month - Any
Study Type
INTERVENTIONAL
Enrollment
3208
Start Date
2020-01-15
Completion Date
2025-12-31
Last Updated
2025-12-30
Healthy Volunteers
No
Conditions
Interventions
IVIG
IVIG at a single dose of 2 g/kg, with the maximum dose of 60g
Aspirin
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.
Prednisolone
Intravenous methylprednisolone 1.6 mg/kg per day (given in 2 divided doses, with the maximum dose 60mg of prednisolone ) for 3 days, which is administered concurrently with the initial IVIG infusion and completed within 30-60 minutes, 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.
Locations (34)
Bengbu First People's Hopital
Bengbu, Anhui, China
Anhui Children's Hospital
Hefei, Anhui, China
Children's Hospital, Capital Institute of Pediatrics
Beijing, Beijing Municipality, China
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Xiamen Children's Hospital
Xiamen, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Shenzhen Children's Hospital
Shenzhen, Guangdong, China
Liuzhou Maternity and Children Healthcare Hospital
Liuchow, Guangxi, China
Kaifeng Children's Hospital
Kaifeng, Henan, China
Henan Children's Hospital
Zhengzhou, Henan, China
the First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Taihe Hospital Affiliated Hospital of Hubei University of Medicine
Shiyan, Hubei, China
Union Hospital,Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, China
Children's Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Children's hospital of Soochow University
Suzhou, Jiangsu, China
Xuzhou Children's Hospital
Xuzhou, Jiangsu, China
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Xi'an Children's Hospital
Xi'an, Shaanxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Qingdao Women and Children's Hospital (Liaoyang West Road)
Qingdao, Shandong, China
Qingdao Women and Children's Hospital
Qingdao, Shandong, China
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
Hangzhou First people's Hospital
Hangzhou, Zhejiang, China
Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China