Longterm Influence of Pediatric Long COVID Syndrome

August 5, 2024 updated by: National Taiwan University Hospital

Longterm Influence of Pediatric Long COVID Syndrome on the Neuropsychiatric Function, Social Function, Neuroimage, and Gut Microbiota

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Children Hospital Pediatric Neurology Department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Aged between 6-18 years old pediatric patient diagnosed as COVID would be enrolled. The patient who had neuropsychiatric disorders would be excluded. We also enroll age- and gender-matched healthy participants for cross-over comparison

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Coronavirus disease (COVID)
Pediatric patients who was diagnosed as COVID
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
Other Names:
  • Neuropsychiatric evaluation
  • Near infrared spectroscopy
Healthy
Pediatric participants who hadn't been diagnosed COVID before
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
Other Names:
  • Neuropsychiatric evaluation
  • Near infrared spectroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between COVID and healthy group
Time Frame: 1 years after enrollment for primary evaluation
The neuroimage difference between COVID and healthy group and the correlation with neuropsychiatric evaluation
1 years after enrollment for primary evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Wang-Tso Lee, PHD, National Taiwan University Children Hospital Pediatric Neurology Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2022

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

October 2, 2022

First Submitted That Met QC Criteria

October 2, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202208086RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

according to our participant consent, the participant information will be stored as de-identification data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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