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Cervical Spine InjuryC-SpineNCT05049330

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

An observational study of Cervical Spine Injury, run by Julie Leonard at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Cervical Spine Injury
How many people
22,444 participants
Where
18 sitesUnited States
Study dates
12 Dec 2018to 1 Jul 2023
How long will I take part?
4 Weeks
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • CS Mott Children's Hospital

    Ann Arbor, Michigan, 48109

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30329

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • The Ohio State University

    Columbus, Ohio, 43210

  • UT Southwestern Medical Center

    Dallas, Pennsylvania, 75235

  • Children's Hospital Colorado

    Denver, Colorado, 80045

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • UCSF Benioff Children's Hospital

    Oakland, California, 94609

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

  • Children's Hospital UC Davis Health

    Sacramento, California, 95817

  • Primary Children's Medical Center

    Salt Lake City, Utah, 84113

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63130

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20310

Other trials in United States

About this study

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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05049330
Study groupRoleWhat they receive
Derivation CohortThe derivation cohort collected data to derive the clinical decision rule.
Validation CohortThe validation cohort collected data to validate the clinical decision rule

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: CSI diagnosed within 21 days of emergency department presentation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2021
  2. Study start12 Dec 2018
  3. Primary completion1 Jul 2023
  4. Study completion1 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
22,444 participants (actual)
Target duration
4 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT05049330
Sponsor's protocol ID
5R01HD091347
Acronym
C-Spine
Status last verified
Apr 2026
First submitted
9 Sep 2021
Last updated
15 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40316355

  • 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.

    PubMed 38843852

  • 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.

    PubMed 37600900

  • 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.

    PubMed 40536503

  • 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.

    PubMed 40836370

  • 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.

    PubMed 40036045

  • 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.

    PubMed 38517085

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Spine Injury, run by Julie Leonard at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cervical Spine Injury (time frame: CSI diagnosed within 21 days of emergency department presentation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05049330, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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