Purpose

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.

Condition

Eligibility

Eligible Ages
Under 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Derivation Cohort The derivation cohort collected data to derive the clinical decision rule.
Validation Cohort The validation cohort collected data to validate the clinical decision rule

Recruiting Locations

Children's National and nearby locations

Children's National Medical Center
Washington, District of Columbia 20310
Contact:
Caleb Ward, MD
888-884-2327
CaWard@childrensnational.org

More Details

NCT ID
NCT05049330
Status
Recruiting
Sponsor
Julie Leonard

Study Contact

Julie C Leonard, MD, MPH
614-355-5860
Julie.Leonard@Nationwidechildrens.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.