NCT05049330

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22,444 (actual)
• Sponsor: Julie Leonard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2018-12-12
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2021-09-20
• Last updated: 2026-04-15
• Results posted: 2026-04-15

Locations

18 sites across 1 country: United States