Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool

Last updated: February 21, 2024
Sponsor: Julie Leonard
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05049330
5R01HD091347
  • Ages < 18
  • All Genders

Study 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

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

Exclusion Criteria:

  • Exposed to solely penetrating trauma (e.g. a gunshot or stab wound)

Study Design

Total Participants: 22222
Study Start date:
December 12, 2018
Estimated Completion Date:
September 01, 2026

Connect with a study center

  • Children's Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • UCSF Benioff Children's Hospital

    Oakland, California 94609
    United States

    Active - Recruiting

  • Children's Hospital UC Davis Health

    Sacramento, California 95817
    United States

    Site Not Available

  • Children's Hospital Colorado

    Denver, Colorado 80045
    United States

    Site Not Available

  • Children's National Medical Center

    Washington, District of Columbia 20310
    United States

    Active - Recruiting

  • Children's Healthcare of Atlanta

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • CS Mott Children's Hospital

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Washington University School of Medicine in St. Louis

    Saint Louis, Missouri 63130
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas, Pennsylvania 75235
    United States

    Active - Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Primary Children's Medical Center

    Salt Lake City, Utah 84113
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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