A randomized controlled non-inferiority trial of IVIG in combination with different doses of aspirin for prevention of coronary artery damage in the acute phase of Kawasaki disease
Conditions
Interventions
Intervention group and control group:IVIG, 2g/kg, single intravenous injection
Oral low-dose aspirin, 3-5 mg/(kg·d), starting from initial treatment and maintained for 6-8 weeks.
control group:IVIG, 2g/kg, single intravenous injection
Aspirin, 30-50mg/(kg·d), taken orally 2-3 times until fever subsides, reduced to 3-5mg/(kg·d), and maintained for 6-8 weeks.
Sponsors
Shenzhen Children's Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. In accordance with KD diagnostic criteria; 2. Voluntary signed informed consent; 3. Male and female, aged <= 18 years old; 4. The initial onset of acute KD was required at the time of enrollment.
Exclusion criteria
Exclusion criteria: 1. With other febrile rash diseases at the first diagnosis; 2. Allergic or adverse reactions are expected to IVIG and aspirin; 3. Incomplete Kawasaki disease was considered at first diagnosis; 4. Combined with KDSS or MAS at first diagnosis; 5. Children with a Kobayashi score more than or equal to five who have already received IVIG or hormones or aspirin; 6. Children who need hormon therapy at first treatment; 7. Refuse to sign informed consent; 8. It is participating in clinical trials of other drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| coronary artery lesion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions of drugs;Clinical symptoms disappear; | — |
Countries
China
Contacts
Public ContactLiang Fangfang
Shenzhen Children's Hospital
Outcome results
None listed