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NCT02392975 · ClinicalTrials.gov registry record · NA
Fast MR for Young Children With Traumatic Brain Injury
A NA study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 225
- Enrollment target
NCT02392975 is a NA study that has completed, run by University of Colorado, Denver. The registered enrollment target is 225 participants.
The verdict
NCT02392975, a NA study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 225 participants
- Enrollment target
Study Summary
This proposal will test the diagnostic utility of fast magnetic resonance (MR) in young children with Traumatic brain Injury (TBI). In children, TBI causes \>2000 deaths, 35,000 hospitalizations and 470,000 emergency department visits in the US each year, making it a leading cause of pediatric disability and death. Currently 20-50% of these children undergo computed tomography (CT) scanning, exposing them to harmful radiation, and increasing their lifetime risk of cancer. Risks are especially increased in children because the neurologic exam is less reliable, because growing tissues are more vulnerable to radiation, and because children have more years to accumulate harmful mutations. Fast MR is a short, motion-tolerant protocol that has been used in children with shunted hydrocephalus to eliminate radiation exposure without the need for sedation. However, fast MR has not been validated in children with TBI, a critical gap. The investigators will measure feasibility and diagnostic utility of fast MR in children \< 6 years (72 months) old who undergo head CT for TBI. The Investigator will recruit children in whom a head CT is ordered for TBI. Consenting subjects will undergo fast MR shortly after CT and results will be compared to determine: 1) whether fast MR identifies all traumatic injuries identified by CT and 2) whether fast MR without sedation can be performed quickly and successfully.
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Fast MR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2015-06-02 |
| Est. Completion | 2018-06-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02392975
The ClinicalTrials.gov registry entry for NCT02392975 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Computed Tomography is the first listed.
NCT02392975 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02392975 about?
NCT02392975 is a clinical study titled "Fast MR for Young Children With Traumatic Brain Injury". This proposal will test the diagnostic utility of fast magnetic resonance (MR) in young children with Traumatic brain Injury (TBI). In children, TBI causes \>2000 deaths, 35,000 hospitalizations and 470,000 emergency department visits in the US each year, making it a leading cause of pediatric disa...
What is the current status of trial NCT02392975?
This trial is currently completed. It is a NA study. The enrollment target is 225 participants. The study started on 2015-06-02. Estimated completion is 2018-06-04.
What interventions are being tested in trial NCT02392975?
The interventions under investigation include: Computed Tomography (PROCEDURE), Fast MR (PROCEDURE).
Who is sponsoring clinical trial NCT02392975?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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