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Epidemiologic Features of Kawasaki Disease in Shanghai From 2013 Through 2017

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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

Tracking Information
First Submitted Date March 6, 2019
First Posted Date March 19, 2019
Last Update Posted Date March 19, 2019
Actual Study Start Date June 1, 2017
Actual Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 15, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 15, 2019)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epidemiologic Features of Kawasaki Disease in Shanghai From 2013 Through 2017
Official Title Epidemiologic Features of Kawasaki Disease in Shanghai From 2013 Through 2017
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All hospitalized patients diagnosed with Kawasaki disease in Shanghai from 2013 through 2017
Condition Mucocutaneous Lymph Node Syndrome
Intervention Other: no intervention
no intervention
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 15, 2019)
4533
Original Actual Enrollment Same as current
Actual Study Completion Date March 1, 2019
Actual Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • not in acute phase;
  • repeated cases;
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03880929
Other Study ID Numbers KD EP4
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Children's Hospital of Fudan University
Study Sponsor Children's Hospital of Fudan University
Collaborators
  • Shanghai Children's Hospital
  • Shanghai Children's Medical Center
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Fang Liu, Dr. Children's Hospital of Fudan University
PRS Account Children's Hospital of Fudan University
Verification Date March 2019