Observational study on diagnosing cervical spine injuries in children after trauma
Pediatric Cervical Spine Clearance: A Multicenter Prospective Observational Study
University of Utah · NCT05608460
This study is trying to see if CT scans or regular X-rays are better at finding neck injuries in kids who have had a serious injury.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15700 (estimated) |
| Ages | 0 Years to 17 Years |
| Sex | All |
| Sponsor | University of Utah (other) |
| Locations | 9 sites (Phoenix, Arizona and 8 other locations) |
| Trial ID | NCT05608460 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study aims to evaluate the effectiveness of CT scans and plain films in diagnosing cervical spine injuries in pediatric patients who have experienced blunt trauma. Led by Dr. Katie Russell at Intermountain Primary Children's Hospital, the study will assess the sensitivity, specificity, and predictive values of these imaging techniques. Participants will include children under 18 years old who have undergone cervical spine imaging. The study is funded by the Primary Children's Hospital foundation.
Who should consider this trial
Good fit: Ideal candidates are children under 18 years old who have suffered blunt trauma and have undergone cervical spine imaging.
Not a fit: Patients with poor quality CT scans from outside facilities or without proper radiology reviews may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing cervical spine injuries in children, leading to better treatment outcomes.
How similar studies have performed: Other studies have shown varying success in using imaging techniques for diagnosing cervical spine injuries, but this specific approach in a pediatric population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any participant less than 18 years old after blunt trauma * Seen by trauma service * With cervical spine imaging (XR, CT, or MRI) Exclusion Criteria: * CT scan from outside facility is poor quality and not repeated (\<63-channel, cuts \>3mm, no reformats, motion artifact) * No radiology over reads by participating institution
Where this trial is running
Phoenix, Arizona and 8 other locations
- Phoenix Children's Hospital — Phoenix, Arizona, United States (NOT_YET_RECRUITING)
- Children's Hospital Los Angeles — Los Angeles, California, United States (NOT_YET_RECRUITING)
- Rady Children's Hospital — San Diego, California, United States (NOT_YET_RECRUITING)
- UCSF Benioff Children's Hospital — San Francisco, California, United States (NOT_YET_RECRUITING)
- Lucile Packard Children's Hospital — Stanford, California, United States (NOT_YET_RECRUITING)
- Children's Hospital Colorado — Aurora, Colorado, United States (NOT_YET_RECRUITING)
- Oregon Health and Science University — Portland, Oregon, United States (NOT_YET_RECRUITING)
- UT Southwestern Medical Center — Dallas, Texas, United States (NOT_YET_RECRUITING)
- Primary Children's Hospital — Salt Lake City, Utah, United States (RECRUITING)
Study contacts
- Principal investigator: Katie Russell, MD — University of Utah
- Study coordinator: Kezlyn Larsen, BS
- Email: kezlyn.larsen@hsc.utah.edu
- Phone: 801-662-2989
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.
Conditions: Cervical Spine Fracture