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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05566392
Other study ID # 202208086RIND
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 20, 2022
Est. completion date December 2030

Study information

Verified date June 2023
Source National Taiwan University Hospital
Contact Wang-Tso Lee, PHD
Phone (886)2-23123456
Email leeped@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

We enroll pediatric patients who were diagnosed COVID-19 for main observation target. We will perform brain MRI and neuropsychiatric evaluation 4-6 months after COVID-19 diagnosed. We also enroll healthy age- and gender-matched participant for cross-over comparison. We will perform same evaluation process one year later for longitudinal evaluation


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 2030
Est. primary completion date October 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria: - Age 6-18 years old - Has been diagnosed COVID-19 before Exclusion Criteria: - History of neuropsychiatric disorders - Have some device not allowed for MRI

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Brain MRI
Brain MRI including diffusion spectrum image, and functional MRI Interview with questionnaires for neuropsychiatric evaluation Near infrared spectroscopy and resting-state connectivity evaluation

Locations

Country Name City State
Taiwan National Taiwan University Children Hospital Pediatric Neurology Department Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference between COVID and healthy group The neuroimage difference between COVID and healthy group and the correlation with neuropsychiatric evaluation 1 years after enrollment for primary evaluation
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