N/A
N=22,430
Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool
Cervical Spine Injury
Bottom Line
View on ClinicalTrials.gov: NCT05049330 ↗Enrolled (actual)
22,430
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Cervical Spine Injury — 274; 159 Participants — p=.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Julie Leonard
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cervical Spine Injury |
274; 159 | .05 |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT05049330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.