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Not recruiting

Observational Study

Sponsor:

Julie Leonard

Code:

NCT05049330

Conditions

Cervical Spine Injury

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Cervical Spine Injury

Study ID

NCT05049330

Start date

Dec 12, 2018

Status verified date

Feb, 2024

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Enrollment

22222 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Develop the Pediatric CSI Risk Assessment Tool in children with blunt trauma using prospective observational data obtained from ED providers [ Time Frame: 8/1/2018 - 7/31/2022 ]
  • Validate the Pediatric CSI Risk Assessment Tool in a separate population of children with blunt trauma using prospective observational data obtained from ED providers [ Time Frame: 8/1/2020-7/31/2023 ]

Central Contacts and Locations

Central contacts

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

UCSF Benioff Children's Hospital

Recruiting

Oakland, California, United States, 94609

Contacts

Children's National Medical Center

Recruiting

Washington, District of Columbia, United States, 20310

Contacts

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

UT Southwestern Medical Center

Recruiting

Dallas, Pennsylvania, United States, 75235

Contacts

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Daniel J Corwin, MD, MSCE

215-590-1000CorwinD@chop.edu

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Daniel M Rubalcava, MD

832-824-5497dr042810@bcm.edu

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

More Information

Sponsor

Julie Leonard

Last update posted

Feb 22, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-01. This information was provided to ClinicalTrials.gov by Julie Leonard on 2024-02-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.