Assessing the risk of cervical spine injuries in children
Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool
This study is trying to create a tool to help doctors figure out which kids who have had blunt trauma might be at risk for neck injuries, so they can make better decisions and avoid unnecessary tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 22222 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Nationwide Children's Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 18 sites (Los Angeles, California and 17 other locations) |
| Trial ID | NCT05049330 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and test a risk assessment tool for cervical spine injuries (CSI) in pediatric patients. It focuses on children aged 0-17 years who have experienced blunt trauma and are undergoing trauma evaluations or imaging. The study seeks to understand the implications of spinal precautions in the prehospital setting and their potential adverse effects, including unnecessary imaging and exposure to radiation. By identifying children at risk for CSI, the study hopes to improve clinical decision-making and reduce harm associated with inappropriate spinal precautions.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0-17 years who have experienced blunt trauma and are undergoing trauma evaluations or imaging.
Not a fit: Patients who have been exposed solely to penetrating trauma, such as gunshot or stab wounds, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective management of pediatric patients with suspected cervical spine injuries.
How similar studies have performed: While spinal precautions in pediatric trauma have been commonly practiced, this study's specific focus on developing a risk assessment tool for CSI in children is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 0-17 years * Known or suspected exposure to blunt trauma At least one of the following applies to the patient: * Undergoing trauma team evaluation * Transported from the scene to participating facility by EMS * Undergoing cervical spine imaging at participating facility * Transferred to participating facility with cervical spine imaging Exclusion Criteria: * Exposed to solely penetrating trauma (e.g. a gunshot or stab wound)
Where this trial is running
Los Angeles, California and 17 other locations
- Children's Hospital Los Angeles — Los Angeles, California, United States (Recruiting)
- UCSF Benioff Children's Hospital — Oakland, California, United States (Recruiting)
- Children's Hospital UC Davis Health — Sacramento, California, United States (Active_not_recruiting)
- Children's Hospital Colorado — Denver, Colorado, United States (Active_not_recruiting)
- Children's National Medical Center — Washington, District of Columbia, United States (Recruiting)
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- CS Mott Children's Hospital — Ann Arbor, Michigan, United States (Active_not_recruiting)
- Washington University School of Medicine in St. Louis — Saint Louis, Missouri, United States (Active_not_recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Active_not_recruiting)
- Nationwide Children's Hospital — Columbus, Ohio, United States (Active_not_recruiting)
- The Ohio State University — Columbus, Ohio, United States (Active_not_recruiting)
- UT Southwestern Medical Center — Dallas, Pennsylvania, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (Active_not_recruiting)
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
- Primary Children's Medical Center — Salt Lake City, Utah, United States (Active_not_recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Julie C Leonard, MD, MPH
- Email: Julie.Leonard@Nationwidechildrens.org
- Phone: 614-355-5860
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.