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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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05049330
Study type Observational [Patient Registry]
Source Nationwide Children's Hospital
Contact Julie C Leonard, MD, MPH
Phone 614-355-5860
Email Julie.Leonard@Nationwidechildrens.org
Status Recruiting
Phase
Start date December 12, 2018
Completion date September 1, 2026

See also
  Status Clinical Trial Phase
Withdrawn NCT05456633 - Clinical and Radiographic Outcomes of Spine Surgeries Utilizing Capri Cervical and Thoracolumbar Corpectomy Cage Systems
Terminated NCT02163876 - Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury Phase 2
Active, not recruiting NCT05605847 - Adherence of Imaging Order to the 2020 French Guidelines for Patients With Cervical Spine Injury in the Emergency Setting
Completed NCT05711134 - CT C-spine Audit and Feedback N/A
Completed NCT02405390 - Head Motion in Pediatric Patients Endotracheally Intubated With Video Laryngoscopy Versus Direct Laryngoscopy N/A