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

NCT05049330 | Completed Results DMC

• 1 other identifier: 5R01HD091347
• Study Type: observational
• Target: 22,444
• Locations: 1 country
• Sites: 18

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.

Conditions

Cervical Spine Injury

Outcome Measures

Primary Outcomes (1)

• Cervical Spine Injury

  The primary outcome used to derive and validate the prediction rule is the presence of cervical spine injury (CSI) defined as vertebral fracture, ligamentous injury, intraspinal hemorrhage, or spinal cord injury involving the cervical region of the spine (occiput to the 7th cervical vertebra, including ligaments attaching the 7th vertebrae to the 1st thoracic vertebra) on any c-spine imaging modality, including x-ray, skeletal survey, CT scan, and/or MRI.

  CSI diagnosed within 21 days of emergency department presentation

Study Arms (2)

Derivation Cohort

The derivation cohort collected data to derive the clinical decision rule.

Validation Cohort

The validation cohort collected data to validate the clinical decision rule

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

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)

Sponsors & Collaborators

• Julie Leonard: lead

Study Sites (18)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

UCSF Benioff Children's Hospital

Oakland, California, 94609, United States

Location

Children's Hospital UC Davis Health

Sacramento, California, 95817, United States

Location

Children's Hospital Colorado

Denver, Colorado, 80045, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20310, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

CS Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63130, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

UT Southwestern Medical Center

Dallas, Pennsylvania, 75235, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84113, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (8)

• Phillips N, Askin GN, Davis GA, O'Brien S, Borland ML, Williams A, Kochar A, John-Denny B, Watson S, George S, Davison M, Dalziel S, Tan E, Chong SL, Craig S, Rao A, Donath SM, Selman CJ, Goergen S, Wilson CL, Singh S, Kuppermann N, Leonard JC, Babl FE. Prospective observational study to assess the performance accuracy of clinical decision rules in children presenting to emergency departments with possible cervical spine injuries: the Study of Neck Injuries in Children (SONIC). BMJ Open. 2025 May 2;15(5):e096294. doi: 10.1136/bmjopen-2024-096294.

  PMID: 40316355 BACKGROUND

• Leonard JC,Harding M,Cook LJ,Leonard JR,Adelgais KM,Ahmad FA,Browne LR,Burger RK,Chaudhari PP,Corwin DJ,Glomb NW,Lee LK,Owusu-Ansah S,Riney LC,Rogers AJ,Rubalcava DM,Sapien RE,Szadkowski MA,Tzimenatos L,Ward CE,Yen K,Kuppermann N

  RESULT

• Gregory ME, Truelove A, Ahmad F, Corwin D, Tzimenatos L, Oglesbee SJ, Herman MJ, Leonard JC. Decision-making for pediatric cervical spine imaging after blunt trauma: Investigating team dynamics in the emergency department. J Am Coll Emerg Physicians Open. 2023 Aug 16;4(4):e13024. doi: 10.1002/emp2.13024. eCollection 2023 Aug.

  PMID: 37600900 RESULT

• Ahmad FA, Browne LR, Glomb NW, Harding M, Cook LJ, Burger RK, Chaudhari PP, Rogers AJ, Ward CE, Rubalcava D, Yen K, Kuppermann N, Leonard JC. Interrater reliability between surgeons and pediatric emergency providers in the cervical spine assessment of injured children. J Trauma Acute Care Surg. 2025 Dec 1;99(6):876-883. doi: 10.1097/TA.0000000000004695. Epub 2025 Jun 19.

  PMID: 40536503 RESULT

• Browne LR, Ward CE, Harding M, Cook LJ, Adelgais KM, Ahmad FA, Burger R, Chaudhari PP, Corwin DJ, Glomb NW, Kuppermann N, Lee LK, Leonard JR, Owusu-Ansah S, Riney LC, Rogers AJ, Rubalcava DM, Sapien RE, Szadkowski MA, Tzimenatos L, Yen K, Leonard JC. Performance of the PECARN cervical spine injury prediction rule based on EMS clinician observations. J Trauma Acute Care Surg. 2025 Dec 1;99(6):928-934. doi: 10.1097/TA.0000000000004772. Epub 2025 Aug 21.

  PMID: 40836370 RESULT

• Ward CE, Browne LR, Rogers AJ, Harding M, Cook LJ, Sapien RE, Adelgais KM, Tzimenatos L, Ahmad FA, Owusu-Ansah S, Leonard JC; Pediatric Emergency Care Applied Research Network (PECARN) Cervical Spine (C-Spine) Study Group. Prevalence and Indications for Applying Prehospital Spinal Motion Restriction in Children at Risk for Cervical Spine Injury. Prehosp Emerg Care. 2025;29(8):1046-1055. doi: 10.1080/10903127.2025.2472269. Epub 2025 Mar 12.

  PMID: 40036045 RESULT

• Leonard JC, Harding M, Cook LJ, Leonard JR, Adelgais KM, Ahmad FA, Browne LR, Burger RK, Chaudhari PP, Corwin DJ, Glomb NW, Lee LK, Owusu-Ansah S, Riney LC, Rogers AJ, Rubalcava DM, Sapien RE, Szadkowski MA, Tzimenatos L, Ward CE, Yen K, Kuppermann N. PECARN prediction rule for cervical spine imaging of children presenting to the emergency department with blunt trauma: a multicentre prospective observational study. Lancet Child Adolesc Health. 2024 Jul;8(7):482-490. doi: 10.1016/S2352-4642(24)00104-4. Epub 2024 Jun 4.

  PMID: 38843852 DERIVED

• Tavender E, Eapen N, Wang J, Rausa VC, Babl FE, Phillips N. Triage tools for detecting cervical spine injury in paediatric trauma patients. Cochrane Database Syst Rev. 2024 Mar 22;3(3):CD011686. doi: 10.1002/14651858.CD011686.pub3.

  PMID: 38517085 DERIVED

Related Links

• A New PECARN Clinical Decision Rule Minimizes Unnecessary Imaging for Pediatric Cervical Spine Injuries

Results Point of Contact

• Title: Julie C. Leonard, MD MPH
• Organization: Nationwide Children's Hospital

julie.leonard@nationwidechildrens.org

6143555856

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 20, 2021
• Study Start: December 12, 2018
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: April 15, 2026
• Results First Posted: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)