Pediatric Cervical Spine Clearance: A Multicenter Prospective Observational Study
1 other identifier
observational
15,700
1 country
9
Brief Summary
A prospective multicenter observational study, led by Dr. Katie Russell of Intermountain Primary Children's Hospital, that will examine the sensitivity, specificity, negative, and positive predictive values of CT scan and plain films in diagnosing cervical spine injury that requires treatment. This study is funded by the Primary Children's Hospital foundation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2022
Typical duration for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2022
CompletedFirst Submitted
Initial submission to the registry
November 1, 2022
CompletedFirst Posted
Study publicly available on registry
November 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2025
CompletedNovember 8, 2022
November 1, 2022
3 years
November 1, 2022
November 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Predictive Values of CT, XR, and MRI
The sensitivity, specificity, negative and positive predictive values of CT, XR, and MRI for clinically significant injury will be calculated.
5 years
Eligibility Criteria
Any participant less than 18 years old after blunt trauma
You may qualify if:
- Any participant less than 18 years old after blunt trauma
- Seen by trauma service
- With cervical spine imaging (XR, CT, or MRI)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Rady Children's Hospital
San Diego, California, 92123, United States
UCSF Benioff Children's Hospital
San Francisco, California, 94158, United States
Lucile Packard Children's Hospital
Stanford, California, 94305, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Katie Russell, MD
University of Utah
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 1, 2022
First Posted
November 8, 2022
Study Start
August 15, 2022
Primary Completion
August 15, 2025
Study Completion
August 15, 2025
Last Updated
November 8, 2022
Record last verified: 2022-11