Hospitalization of Infants and Children Aged 0-4 Years with Laboratory-Confirmed COVID-19 - COVID-NET, 14 States, March 2020-February 2022.
Kristin J Marks, Michael Whitaker, Nickolas T Agathis...
https://pubmed.ncbi.nlm.nih.gov/35298458Actively Recruiting
Age: 0 - 18Years
All Genders
Healthy Volunteers
ID05582512
Clinical Characteristics and Long Term Impact on Pediatric COVID-19 in Taiwan
Led by National Taiwan University Hospital · Updated on 2023-11-18
3000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates severe COVID-19 factors in children, including host genes, biomarkers, and the prognosis of severe encephalitis. The study includes retrospective analysis of pediatric COVID-19 cases to identify severe disease factors, prospective assessment of host-virus interactions and severity, and long-term tracking of children with "Long COVID-19 Syndrome". It also explores seroepidemiology among healthcare workers and the community to better understand infection profiles and immune responses in children. The study consists of multiple groups: a retrospective group analyzing clinical data from hospitalized children under 18; an acute case group including children with multisystem inflammatory syndrome; a long COVID-19 tracking group conducting systematic outpatient assessments of body, lung, neurological, and psychological function; a seroepidemiological group studying antibody prevalence among healthcare workers and the public; and a healthy control group. Various tests include whole exome sequencing, microbiota analysis, biomarker measurement, brain MRI, neurophysiological exams, and immune function tests. Participants undergo evaluations including physical exams, neurological and pulmonary function tests, brain imaging, neuropsychological assessments, psychiatric interviews, and laboratory tests for immune and inflammatory markers. Monitoring includes heart rate variability, sleep studies, and antibody testing. The main outcomes measured are risk factors and complications over 3 months, fatigue levels at one month, and COVID-19 seropositivity on a single day. The study aims to clarify the long-term effects of COVID-19 on children's health and immunity, with expected participation of several thousand children and adults.
CONDITIONS
Brief Title
Clinical Characteristics and Long Term Impact on Pediatric COVID-19 in Taiwan
Who Can Participate
Age: 0 - 18Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- COVID-19 positive cases
- Participants younger than 18 years old
You will not qualify if you...
- Presence of metal implants or devices that cannot be removed, such as braces, metal nails, artificial electronic ears, or pacemakers
- Major physical diseases
- Sensory impairments such as deafness
- Movement disorders such as cerebral palsy
- Uncontrolled and stable epilepsy
- Pregnancy or uncertainty about pregnancy status
- History of hypoxia due to encephalitis or other causes not related to enterovirus infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Clinical Characteristics Data Collection
Duration - Retrospective data collection covering January 1, 2020 to June 13, 2022
Participants who were COVID-19 positive and younger than 18 years old have their clinical data retrospectively collected and analyzed to identify risk factors and complications.
No visits required (retrospective study)
Acute Case Receiving Group Assessments
Duration - 7 to 14 days for physiological monitoring; other assessments as scheduled
Participants with acute COVID-19 or multisystem inflammatory syndrome undergo tests including host gene studies, microbiota, immune biomarkers, neurological, pulmonary, brain imaging, physiological monitoring, and other clinical examinations based on symptoms.
Multiple visits depending on tests needed
Children's Long COVID-19 Tracking
Duration - Long-term tracking over several months to years
Participants with long COVID-19 are systematically tracked through outpatient visits assessing body, lung function, neurological and psychological status, including brain MRI, neurophysiological exams, psychiatric interviews, cognitive testing, and immune function analysis.
Multiple outpatient visits scheduled over time
Seroepidemiological Research
Duration - 6 months
Participants including medical staff and general public undergo blood draws for COVID-19 antibody testing at baseline, 3 months, and 6 months to understand antibody prevalence and decline.
3 visits for blood draws (baseline, 3 months, 6 months)
Healthy Control Group Assessments
Duration - Assessment scheduled to match acute case group timing
Healthy participants undergo assessments including respiratory and intestinal microbiota analysis, immune biomarkers, brain MRI, neurophysiological exams, brain injury biomarkers, and host transcriptome research to serve as controls.
Multiple visits depending on assessments
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Chung Cheng District, Taiwan, 100
Actively Recruiting
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Research Team
T
Tsui-Yien Fan, RA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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Dallas S Shi, Michael Whitaker, Kristin J Marks...
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Sujit Sharma, Beesan Agha, Carlos Delgado...
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Ryan Cl Brewster, Chase Parsons, Jess Laird-Gion...
https://pubmed.ncbi.nlm.nih.gov/35257175Acute Upper Airway Disease in Children With the Omicron (B.1.1.529) Variant of SARS-CoV-2-A Report From the US National COVID Cohort Collaborative.
Blake Martin, Peter E DeWitt, Seth Russell...
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Takaki Asano, Bertrand Boisson, Fanny Onodi...
https://pubmed.ncbi.nlm.nih.gov/34413140Mechanisms underlying genetic susceptibility to multisystem inflammatory syndrome in children (MIS-C).
Janet Chou, Craig D Platt, Saddiq Habiballah...
https://pubmed.ncbi.nlm.nih.gov/34224783Neurologic and neuroimaging findings in patients with COVID-19: A retrospective multicenter study.
Stéphane Kremer, François Lersy, Mathieu Anheim...
https://pubmed.ncbi.nlm.nih.gov/32680942Neurologic Involvement in Children and Adolescents Hospitalized in the United States for COVID-19 or Multisystem Inflammatory Syndrome.
Kerri L LaRovere, Becky J Riggs, Tina Y Poussaint...
https://pubmed.ncbi.nlm.nih.gov/33666649