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NCT04899245 · ClinicalTrials.gov registry record · NA
ReSET Aim 1b: Restarting Safe Education and Testing for Children With Medical Complexity - COVID-19 Testing in School With Children and Staff
A NA study of COVID-19 and Children With Medical Complexity (CMC), sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- NA
- Development phase
- 112
- Enrollment target
- 1
- Study location
NCT04899245 is a NA study of COVID-19 and Children With Medical Complexity (CMC) that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 112 participants, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04899245, a NA study of COVID-19 and Children With Medical Complexity (CMC), has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- NA
- Development phase
- 112 participants
- Enrollment target
- 1
- Study location
Study Summary
The Coronavirus Disease 2019 (COVID-19), caused by the SARS-CoV-2 virus, is a worldwide pandemic that has resulted in large-scale quarantines in cities, states, and countries throughout the world. SARS-CoV-2 is a respiratory virus that is most commonly spread via contact with infective respiratory droplets and aerosols produced by coughing, sneezing, talking, and singing. Children with medical complexity (CMC), i.e., children with multiple severe chronic conditions, high resource use, severe functional limitations, and substantial family-identified service needs, are a medically vulnerable population for the development of severe COVID-19. Deciding to send CMC to school poses a major dilemma to families wanting to minimize severe COVID-19 risk. School personnel also face risks when CMC attend school. Despite these challenges, achieving in-person school attendance is critical for CMC. Compared to non-CMC, academic and social development for most CMC hinges on being at school. Severe intellectual and developmental disability impairs one's ability to engage with online platforms. Health-promoting services delivered at school, e.g., physical, occupational, and speech therapy, are likely less effective when delivered virtually. Parents of CMC, already disproportionately unemployed due to their child's care needs, experience added employment strain when their child is out of school. The study objective is to increase the safe return to school for CMC by 1) evaluating the feasibility of school-based COVID-19 testing strategies and 2) identifying parent and staff perceptions of testing and school attendance. A related study (ReSET Aim 1a, NCT04895085) will evaluate the same factors in home-based testing strategies in CMC exclusively.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST BinaxNOW Rapid Antigen System
Study Locations (1)
Wisconsin
- University of Wisconsin School of Medicine and Public Health - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2021-05-04 |
| Est. Completion | 2023-09-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04899245
The ClinicalTrials.gov registry entry for NCT04899245 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which BinaxNOW Rapid Antigen System is the first listed.
NCT04899245 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04899245 about?
NCT04899245 is a clinical study titled "ReSET Aim 1b: Restarting Safe Education and Testing for Children With Medical Complexity - COVID-19 Testing in School With Children and Staff". The Coronavirus Disease 2019 (COVID-19), caused by the SARS-CoV-2 virus, is a worldwide pandemic that has resulted in large-scale quarantines in cities, states, and countries throughout the world. SARS-CoV-2 is a respiratory virus that is most commonly spread via contact with infective respiratory d...
What is the current status of trial NCT04899245?
This trial is currently completed. It is a NA study. The enrollment target is 112 participants. The study started on 2021-05-04. Estimated completion is 2023-09-01.
What conditions does trial NCT04899245 study?
This clinical trial studies the following conditions: COVID-19, Children With Medical Complexity (CMC).
What interventions are being tested in trial NCT04899245?
The interventions under investigation include: BinaxNOW Rapid Antigen System (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04899245?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04899245 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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