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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
Sponsor:
Collaborators:
Shanghai Children's Hospital
Shanghai Children's Medical Center
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Mucocutaneous Lymph Node Syndrome Other: no intervention

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.

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Study Type : Observational
Actual Enrollment : 4533 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kawasaki Disease


Intervention Details:
  • Other: no intervention
    no intervention


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All hospitalized patients diagnosed with Kawasaki disease in Shanghai from 2013 through 2017
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • not in acute phase;
  • repeated cases;

Information from the National Library of Medicine

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


Locations
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China, Shanghai
Children's Hospital of Fudan University
Shanghai, Shanghai, China, 201122
Sponsors and Collaborators
Children's Hospital of Fudan University
Shanghai Children's Hospital
Shanghai Children's Medical Center
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Fang Liu, Dr. Children's Hospital of Fudan University
  Study Documents (Full-Text)

Documents provided by Children's Hospital of Fudan University:
Publications:
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Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03880929    
Other Study ID Numbers: KD EP4
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Fudan University:
kawasaki disease
coronary artery lesion
epidemiology
Additional relevant MeSH terms:
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Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases