Clinical trial NCT05049330: Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool
Official title: Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Spine Injury
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 22222
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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)

Primary outcomes:
measure: Develop the Pediatric CSI Risk Assessment Tool in children with blunt trauma using prospective observational data obtained from ED providers
timeFrame: 8/1/2018 - 7/31/2022
measure: Validate the Pediatric CSI Risk Assessment Tool in a separate population of children with blunt trauma using prospective observational data obtained from ED providers
timeFrame: 8/1/2020-7/31/2023
Secondary outcomes:
measure: Validate the Pediatric CSI Risk Assessment Tool using prospective observational data obtained from EMS providers.
timeFrame: 8/1/2018-7/31/2023
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital
state: California
city: Sacramento
country: United States
facility: Children's Hospital UC Davis Health
state: California
city: Denver
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: CS Mott Children's Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Medical Center
state: Utah
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: