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

Sponsor
Julie Leonard (Other)
Overall Status
Recruiting
CT.gov ID
NCT05049330
Collaborator
(none)
22,222
Enrollment
18
Locations
56.6
Anticipated Duration (Months)
1234.6
Patients Per Site
21.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    22222 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool
    Actual Study Start Date :
    Dec 12, 2018
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Develop the Pediatric CSI Risk Assessment Tool in children with blunt trauma using prospective observational data obtained from ED providers [8/1/2018 - 7/31/2022]

    2. Validate the Pediatric CSI Risk Assessment Tool in a separate population of children with blunt trauma using prospective observational data obtained from ED providers [8/1/2020-7/31/2023]

    Secondary Outcome Measures

    1. Validate the Pediatric CSI Risk Assessment Tool using prospective observational data obtained from EMS providers. [8/1/2018-7/31/2023]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital Los Angeles Los Angeles California United States 90027
    2 UCSF Benioff Children's Hospital Oakland California United States 94609
    3 Children's Hospital UC Davis Health Sacramento California United States 95817
    4 Children's Hospital Colorado Denver Colorado United States 80045
    5 Children's National Medical Center Washington District of Columbia United States 20310
    6 Children's Healthcare of Atlanta Atlanta Georgia United States 30329
    7 Boston Children's Hospital Boston Massachusetts United States 02115
    8 CS Mott Children's Hospital Ann Arbor Michigan United States 48109
    9 Washington University School of Medicine in St. Louis Saint Louis Missouri United States 63130
    10 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    11 Nationwide Children's Hospital Columbus Ohio United States 43205
    12 The Ohio State University Columbus Ohio United States 43210
    13 UT Southwestern Medical Center Dallas Pennsylvania United States 75235
    14 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    15 UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15224
    16 Texas Children's Hospital Houston Texas United States 77030
    17 Primary Children's Medical Center Salt Lake City Utah United States 84113
    18 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Julie Leonard

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Julie Leonard, Principal Investigator, Nationwide Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT05049330
    Other Study ID Numbers:
    • 5R01HD091347
    First Posted:
    Sep 20, 2021
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Wounds and Injuries
    Spinal Injuries

    Study Results

    No Results Posted as of Nov 3, 2021