Epidemiologic Features of Kawasaki Disease in Shanghai From 2013 Through 2017
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03880929|
Recruitment Status : Completed
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
|Condition or disease||Intervention/treatment|
|Mucocutaneous Lymph Node Syndrome||Other: no intervention|
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 Type :||Observational|
|Actual Enrollment :||4533 participants|
|Official Title:||Epidemiologic Features of Kawasaki Disease in Shanghai From 2013 Through 2017|
|Actual Study Start Date :||June 1, 2017|
|Actual Primary Completion Date :||January 1, 2019|
|Actual Study Completion Date :||March 1, 2019|
- Other: no intervention
- Incidence of coronary artery lesions [ Time Frame: 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.
- Incidence of intravenous immunoglobulin resistance [ Time Frame: from admision 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 [ Time Frame: from admisson 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880929
|Children's Hospital of Fudan University|
|Shanghai, Shanghai, China, 201122|
|Principal Investigator:||Fang Liu, Dr.||Children's Hospital of Fudan University|