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

Cervical Spine Injury Clinical Trial

— C-Spine  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05049330
• Other study ID #: 5R01HD091347
• Status: Recruiting
• Start date: December 12, 2018
• Est. completion date: September 1, 2026

Study information

• Verified date: February 2024
• Source: Nationwide Children's Hospital
• Contact: Julie C Leonard, MD, MPH
• Phone: 614-355-5860
• Email: Julie.Leonard[@]Nationwidechildrens.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22222
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cervical Spine Injury
• Spinal Injuries
• Wounds and Injuries

Locations

Country	Name	City	State
United States	CS Mott Children's Hospital	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	UT Southwestern Medical Center	Dallas	Pennsylvania
United States	Children's Hospital Colorado	Denver	Colorado
United States	Texas Children's Hospital	Houston	Texas
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	UCSF Benioff Children's Hospital	Oakland	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Children's Hospital UC Davis Health	Sacramento	California
United States	Washington University School of Medicine in St. Louis	Saint Louis	Missouri
United States	Primary Children's Medical Center	Salt Lake City	Utah
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Julie Leonard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Validate the Pediatric CSI Risk Assessment Tool using prospective observational data obtained from EMS providers.		8/1/2018-7/31/2023