Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05049330
Recruitment Status : Recruiting
First Posted : September 20, 2021
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Julie Leonard, Nationwide Children's Hospital

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
Cervical Spine Injury

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 22222 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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 ]
  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 [ Time Frame: 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. [ Time Frame: 8/1/2018-7/31/2023 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05049330


Contacts
Layout table for location contacts
Contact: Julie C Leonard, MD, MPH 614-355-5860 Julie.Leonard@Nationwidechildrens.org

Locations
Show Show 18 study locations
Sponsors and Collaborators
Julie Leonard
  Study Documents (Full-Text)

Documents provided by Julie Leonard, Nationwide Children's Hospital:
Study Protocol  [PDF] December 22, 2020

Layout table for additonal information
Responsible Party: Julie Leonard, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT05049330    
Other Study ID Numbers: 5R01HD091347 ( U.S. NIH Grant/Contract )
First Posted: September 20, 2021    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries
Spinal Injuries
Back Injuries