Epidemiologic Features of Kawasaki Disease in Shanghai From 2013 Through 2017

Completed

• Conditions: Mucocutaneous Lymph Node Syndrome

• Registration Number: NCT03880929
• Lead Sponsor: Children's Hospital of Fudan University

Brief Summary

To investigate the epidemiologic features of Kawasaki disease (KD) in Shanghai from 2013 through 2017 and identify the risk factors for coronary artery lesions.

Detailed Description

Based on the KD research group network established during the first survey in Shanghai, a set of questionnaires and diagnostic guidelines for KD will be sent to 50 hospitals providing pediatric medical care in Shanghai, China. Medical records of participants with KD diagnosed from January 2013 through December 2017 will be retrospectively analyzed. Data are collected by pediatricians, including demographic information, clinical manifestations, prognosis, laboratory indexes, treatment and echocardiographic findings.

Age and seasonal distribution at onset, treatment and cardiac abnormalities wil be described. Univariate and multivariate analyses will be performed to identify risk factors for coronary artery lesions.

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-03-01
• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-15
• Study First Posted: 2019-03-19
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4533

Inclusion Criteria

• meeting the diagnostic criteria for Kawasaki disease released by American Heart Association 2017

Exclusion Criteria

• not in acute phase;
• repeated cases;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of coronary artery lesions	from admission to one month after onset	Coronary artery lesions were identified with two-dimensional echocardiography in the acute phase (within one month of onset). Participants were considered to have coronary artery lesions if the luminal diameter of a coronary artery was \>3.0 mm in children aged younger than 5 years or \>4.0 mm in those aged 5 years and older, or when the internal diameter of a segment was ≥1.5 times that of an adjacent segment.

Secondary Outcome Measures

Name	Time	Method
Incidence of intravenous immunoglobulin resistance	from admission to discharge (about two weeks after onset)	Ear temperature was measured each day during hospitalization. Intravenous immunoglobulin (IVIG) resistance was defined as persistent fever (\>38°C) after 36 hours of completion of initial IVIG infusion or recurrent fever requiring another dose of IVIG or other adjunctive therapies.
Risk factors associated with coronary artery lesions	from admission to one month after onset	Multivariate logistic regressions were performed to identify risk factors that were independently associated with coronary artery lesions. Odds ratio and 95% CI were calculated for each variable.

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China