Longterm Influence of Pediatric Long COVID Syndrome

NCT05566392 | Recruiting DMC

• 1 other identifier: 202208086RIND
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

COVID-19-Associated Encephalitis; Long COVID

Keywords

pediatric neurology; psychiatric evaluation; Long COVID syndrome; magnetic resonance image

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Coronavirus disease (COVID)

Pediatric patients who was diagnosed as COVID

Diagnostic Test: Brain MRI

Healthy

Pediatric participants who hadn't been diagnosed COVID before

Diagnostic Test: Brain MRI

Interventions

Brain MRI DIAGNOSTIC_TEST

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

Also known as: Neuropsychiatric evaluation, Near infrared spectroscopy

Coronavirus disease (COVID); Healthy

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• Age 6-18 years old
• Has been diagnosed COVID-19 before

You may not qualify if:

• History of neuropsychiatric disorders
• Have some device not allowed for MRI

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Children Hospital Pediatric Neurology Department

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Wang-Tso Lee, PHD

  National Taiwan University Children Hospital Pediatric neurology department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang-Tso Lee, PHD

CONTACT

(886)2-23123456; leeped@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2022
• First Posted: October 4, 2022
• Study Start: October 20, 2022
• Primary Completion: October 1, 2025
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)