RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-12-12
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05049330

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.

Ages Eligible for Study:Not specified to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 0-17 years
  2. * Known or suspected exposure to blunt trauma
  3. * Undergoing trauma team evaluation
  4. * Transported from the scene to participating facility by EMS
  5. * Undergoing cervical spine imaging at participating facility
  6. * Transferred to participating facility with cervical spine imaging
  1. * Exposed to solely penetrating trauma (e.g. a gunshot or stab wound)

Contacts and Locations

Study Contact

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Julie Leonard

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 Registration Dates

Study Start Date2018-12-12
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2018-12-12
Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Cervical Spine Injury