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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
At least one of the following applies to the patient:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| UCSF Benioff Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40316355 | Background | 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. | |
| 38843852 |
| Label | URL |
|---|---|
| A New PECARN Clinical Decision Rule Minimizes Unnecessary Imaging for Pediatric Cervical Spine Injuries | View source |
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In the database, fourteen subjects were found to be duplicate enrollments.
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| ID | Title | Description |
|---|---|---|
| FG000 | Derivation Cohort | The derivation cohort collected data to derive the clinical decision rule. |
| FG001 | Validation Cohort | The validation cohort collected data to validate the clinical decision rule |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 22, 2020 | Aug 6, 2021 |
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| Oakland |
| California |
| 94609 |
| United States |
| Children's Hospital UC Davis Health | Sacramento | California | 95817 | United States |
| Children's Hospital Colorado | Denver | Colorado | 80045 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20310 | United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30329 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| CS Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63130 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| UT Southwestern Medical Center | Dallas | Pennsylvania | 75235 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Primary Children's Medical Center | Salt Lake City | Utah | 84113 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| 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. |
| 37600900 | 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. |
| 40536503 | 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. |
| 40836370 | 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. |
| 40036045 | 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. |
| 38517085 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Derivation Cohort | The derivation cohort collected data to derive the clinical decision rule. |
| BG001 | Validation Cohort | The validation cohort collected data to validate the clinical decision rule |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Children aged 0-17 years with known or suspected blunt trauma at 18 emergency departments affiliated with the Pediatric Emergency Care Applied Research Network. Eligible children were transported from the scene of injury to the emergency department by emergency medical services; evaluated by a trauma team; and/or underwent neck imaging for concern for cervical spine injury. Children with solely penetrating trauma were excluded. | Posted | Count of Participants | Participants | CSI diagnosed within 21 days of emergency department presentation |
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Adverse event data were collected for the 21 days following their emergency department visit.
This was strictly a prospective observational study to generate a clinical prediction rule. Adverse events in the context of the study design would solely be related to breaches in privacy related to the collection of patient information. However, in order to generate a robust clinical prediction rule, we monitored for cervical spine injuries (CSI) missed during their original emergency department visit and subsequent neurologic outcome.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Derivation Cohort | The derivation cohort collected data to derive the clinical decision rule. | 60 | 11,857 | 0 | 11,857 | 0 | 11,857 |
| EG001 | Validation Cohort | The validation cohort collected data to validate the clinical decision rule | 54 | 10,573 | 0 | 10,573 | 0 | 10,573 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie C. Leonard, MD MPH | Nationwide Children's Hospital | 6143555856 | julie.leonard@nationwidechildrens.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 31, 2023 | Nov 29, 2024 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form: CSI Identified Diversity Supplement Cover Letter | Aug 7, 2021 | Aug 30, 2021 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: User Centered Design Cover Letter | Aug 7, 2021 | Aug 30, 2021 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Consent Authorization Cover Letter | Aug 7, 2021 | Aug 30, 2021 | ICF_003.pdf |
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| .05 |
| Point estimate |
| 94.3 |
| 2-Sided |
| 95 |
| 90.7 |
| 97.9 |
| Other |
| Specificity | .05 | Point estimate | 59.5 | 2-Sided | 95 | 58.6 | 60.4 | Other |
| Specificity | .05 | point | 60.4 | 2-Sided | 95 | 59.4 | 61.3 | Other |
| Positive Predictive Value | .05 | Point estimate | 5.4 | 2-Sided | 95 | 4.5 | 5.7 | Other |
| Positive Predictive Value | .05 | Point estimate | 3.5 | 2-Sided | 95 | 3.0 | 4.1 | Other |
| Negative Predictive Value | .05 | Point estimate | 99.7 | 2-Sided | 95 | 99.6 | 99.8 | Other |
| Negative Predictive Value | 0.5 | Point estimate | 99.9 | 2-Sided | 95 | 99.8 | 100.0 | Other |