Kawasaki Disease
Conditions
Interventions
Experimental (early treatment) group:Intravenous immunoglobulin (IVIG) was administered within 4 days of disease onset.
Control (standard treatment) group:Intravenous immunoglobulin (IVIG) was administered on day 5 of the disease course.
Sponsors
Guangzhou Women and Children's Medical Center,Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of complete (typical) Kawasaki disease within 96 hours of fever onset per the 2017 AHA Scientific Statement criteria. 2. Fever duration < 96 hours at enrollment. 3. No prior IVIG administration in the current illness. 4. Aged < 18 years (per the UN Convention on the Rights of the Child). 5. Written informed consent signed by legal guardians.
Exclusion criteria
Exclusion criteria: 1. Afebrile for >= 24 h prior to randomization; 2. Prior hypersensitivity to IVIG; 3. IVIG use within 90 days and/or glucocorticoids (oral/IV/IM/mucosal) within 7 days before enrollment; nebulized preparations excluded; 4. Severe underlying diseases (e.g., immunodeficiency, chromosomal anomalies); 5. Enrolled in any other clinical drug trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total fever duration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rescue rate (IVIG non-response rate);Max coronary artery Z-score (4-week follow-up);CAL at 4-week follow-up (Z-score >= 2.5);Changes in inflammatory markers post first IVIG vs. baseline;Time to fever resolution post-IVIG; | — |
Countries
China
Contacts
Public ContactWang Zhou-Ping
Guangzhou Women and Children's Medical Center,Guangzhou Medical University
Outcome results
None listed