Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool (C-Spine)

April 13, 2026 updated by: Julie Leonard
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

22444

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
      • Oakland, California, United States, 94609
        • UCSF Benioff Children's Hospital
      • Sacramento, California, United States, 95817
        • Children's Hospital UC Davis Health
    • Colorado
      • Denver, Colorado, United States, 80045
        • Children's Hospital Colorado
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20310
        • Children's National Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Children's Healthcare of Atlanta
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • CS Mott Children's Hospital
    • Missouri
      • St Louis, Missouri, United States, 63130
        • Washington University School of Medicine in St. Louis
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Pennsylvania
      • Dallas, Pennsylvania, United States, 75235
        • UT Southwestern Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15224
        • UPMC Children's Hospital of Pittsburgh
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Primary Children's Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children aged 0-17 years with known or suspected blunt trauma exposure that arrive at participating children's hospitals and meet study eligibility criteria. No exclusion based on sex/gender, race, ethnic group, or language.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical Spine Injury
Time Frame: CSI diagnosed within 21 days of emergency department presentation
The primary outcome used to derive and validate the prediction rule is the presence of cervical spine injury (CSI) defined as vertebral fracture, ligamentous injury, intraspinal hemorrhage, or spinal cord injury involving the cervical region of the spine (occiput to the 7th cervical vertebra, including ligaments attaching the 7th vertebrae to the 1st thoracic vertebra) on any c-spine imaging modality, including x-ray, skeletal survey, CT scan, and/or MRI.
CSI diagnosed within 21 days of emergency department presentation

Secondary Outcome Measures

Outcome Measure
Time Frame
Validate the Pediatric CSI Risk Assessment Tool using prospective observational data obtained from EMS providers.
Time Frame: 8/1/2018-7/31/2023
8/1/2018-7/31/2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Julie Leonard

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2018

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

September 9, 2021

First Posted (Actual)

September 20, 2021

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5R01HD091347 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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