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Epidemiologic Features of Kawasaki Disease in Shanghai From 2013 Through 2017

Epidemiologic Features of Kawasaki Disease in Shanghai From 2013 Through 2017

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03880929
Enrollment
4533
Registered
2019-03-19
Start date
2017-06-01
Completion date
2019-03-01
Last updated
2023-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Keywords

kawasaki disease, coronary artery lesion, epidemiology

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.

Interventions

OTHERno intervention

no intervention

Sponsors

Shanghai Children's Hospital
CollaboratorOTHER
Shanghai Children's Medical Center
CollaboratorOTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* not in acute phase; * repeated cases;

Design outcomes

Primary

MeasureTime frameDescription
Incidence of coronary artery lesionsfrom admission to one month after onsetCoronary 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

MeasureTime frameDescription
Incidence of intravenous immunoglobulin resistancefrom 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 lesionsfrom admission to one month after onsetMultivariate 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026