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

Completed

Conditions studied: Cervical Spine Injury

In brief

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.

Key facts

Study ID

NCT05049330

Run by

Julie Leonard

People needed

22444

Starts

2018-12-12

Expected to finish

2023-07-01

Last updated by the study team

2026-04-15

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Exposed to solely penetrating trauma (e.g. a gunshot or stab wound)

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• UCSF Benioff Children's Hospital — Oakland, California, United States
• Children's Hospital UC Davis Health — Sacramento, California, United States
• Children's Hospital Colorado — Denver, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• CS Mott Children's Hospital — Ann Arbor, Michigan, United States
• Washington University School of Medicine in St. Louis — St Louis, Missouri, 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 of Philadelphia — Philadelphia, Pennsylvania, United States
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Texas Children's Hospital — Houston, Texas, United States
• Primary Children's Medical Center — Salt Lake City, Utah, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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