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NCT05049330 · ClinicalTrials.gov registry record
Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool
A clinical trial of Cervical Spine Injury, sponsored by Julie Leonard.
- Recruiting
- Registry status
- 22,222
- Enrollment target
- 18
- Study locations
NCT05049330 is a study of Cervical Spine Injury that is actively recruiting participants, run by Julie Leonard. The registered enrollment target is 22,222 participants. The trial reports 18 study locations across 12 states.
The verdict
NCT05049330, a study of Cervical Spine Injury, is actively recruiting participants, sponsored by Julie Leonard.
- RECRUITING
- Registry status
- 22,222 participants
- Enrollment target
- 18
- Study locations
Study Summary
Cervical spine injuries (CSI) are serious, but rare events in children. Spinal precautions (rigid cervical collar and immobilization on a longboard) in the prehospital setting may be beneficial for children with CSI, but are poorly studied. In contrast, spinal precautions for pediatric trauma patients without CSI are common and may be associated with harm. Spinal precautions result in well-documented adverse physical and physiological sequelae. Of substantial concern is that the mere presence of prehospital spinal precautions may lead to a cascade of events that results in the increased use of inappropriate radiographic testing in the emergency department (ED) to evaluate children for CSI and thus an unnecessary, increased exposure to ionizing radiation and lifetime risk of cancer. Most children who receive spinal precautions and/or are imaged for potential CSI, and particularly those imaged with computed tomography (CT), are exposed to potential harm with no demonstrable benefit. Therefore, there is an urgent need to develop a Pediatric CSI Risk Assessment Tool that can be used in the prehospital and ED settings to reduce the number of children who receive prehospital spinal precautions inappropriately and are imaged unnecessarily while identifying all children who are truly at risk for CSI.
Conditions Studied
Study Locations (18)
California
- Children's Hospital Los Angeles - Los Angeles
- UCSF Benioff Children's Hospital - Oakland
- Children's Hospital UC Davis Health - Sacramento
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
- The Ohio State University - Columbus
Pennsylvania
- UT Southwestern Medical Center - Dallas
- Children's Hospital of Philadelphia - Philadelphia
- UPMC Children's Hospital of Pittsburgh - Pittsburgh
Colorado
- Children's Hospital Colorado - Denver
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- Children's Healthcare of Atlanta - Atlanta
Massachusetts
- Boston Children's Hospital - Boston
Michigan
- CS Mott Children's Hospital - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22,222 participants |
| Start Date | 2018-12-12 |
| Est. Completion | 2026-09-01 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05049330
The ClinicalTrials.gov registry entry for NCT05049330 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 22,222 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Julie Leonard, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cervical Spine Injury appearing as the primary indexed condition, and to 0 interventions.
NCT05049330 reports 18 study locations spanning 12 distinct geographic areas - top geographies include California, Ohio, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05049330 about?
NCT05049330 is a clinical study titled "Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool". Cervical spine injuries (CSI) are serious, but rare events in children. Spinal precautions (rigid cervical collar and immobilization on a longboard) in the prehospital setting may be beneficial for children with CSI, but are poorly studied. In contrast, spinal precautions for pediatric trauma patien...
What is the current status of trial NCT05049330?
This trial is currently recruiting. The enrollment target is 22,222 participants. The study started on 2018-12-12. Estimated completion is 2026-09-01.
What conditions does trial NCT05049330 study?
This clinical trial studies the following conditions: Cervical Spine Injury.
Who is sponsoring clinical trial NCT05049330?
This trial is sponsored by Julie Leonard, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05049330 being conducted?
This trial has 18 study locations across California, Colorado, District of Columbia, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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