Trial Outcomes & Findings for Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool (NCT NCT05049330)

Last Updated: 2026-04-15

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

22444 participants

Primary outcome timeframe

CSI diagnosed within 21 days of emergency department presentation

Results posted on

2026-04-15

Participant Flow

In the database, fourteen subjects were found to be duplicate enrollments.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	11857	10573
Overall Study COMPLETED	11857	10573
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Derivation Cohort n=11857 Participants The derivation cohort collected data to derive the clinical decision rule.	Validation Cohort n=10573 Participants The validation cohort collected data to validate the clinical decision rule	Total n=22430 Participants Total of all reporting groups
Age, Categorical <=18 years	11857 Participants n=193 Participants	10573 Participants n=193 Participants	22430 Participants n=386 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=193 Participants	0 Participants n=193 Participants	0 Participants n=386 Participants
Age, Categorical >=65 years	0 Participants n=193 Participants	0 Participants n=193 Participants	0 Participants n=386 Participants
Sex: Female, Male Female	5002 Participants n=193 Participants	4360 Participants n=193 Participants	9362 Participants n=386 Participants
Sex: Female, Male Male	6855 Participants n=193 Participants	6213 Participants n=193 Participants	13068 Participants n=386 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1712 Participants n=193 Participants	2618 Participants n=193 Participants	4330 Participants n=386 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10145 Participants n=193 Participants	7955 Participants n=193 Participants	18100 Participants n=386 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=193 Participants	0 Participants n=193 Participants	0 Participants n=386 Participants
Race (NIH/OMB) American Indian or Alaska Native	87 Participants n=193 Participants	24 Participants n=193 Participants	111 Participants n=386 Participants
Race (NIH/OMB) Asian	252 Participants n=193 Participants	220 Participants n=193 Participants	472 Participants n=386 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	73 Participants n=193 Participants	26 Participants n=193 Participants	99 Participants n=386 Participants
Race (NIH/OMB) Black or African American	2693 Participants n=193 Participants	4100 Participants n=193 Participants	6793 Participants n=386 Participants
Race (NIH/OMB) White	6471 Participants n=193 Participants	4435 Participants n=193 Participants	10906 Participants n=386 Participants
Race (NIH/OMB) More than one race	369 Participants n=193 Participants	42 Participants n=193 Participants	411 Participants n=386 Participants
Race (NIH/OMB) Unknown or Not Reported	1912 Participants n=193 Participants	1726 Participants n=193 Participants	3638 Participants n=386 Participants
Region of Enrollment United States	11857 Participants n=193 Participants	10573 Participants n=193 Participants	22430 Participants n=386 Participants

PRIMARY outcome

Timeframe: CSI diagnosed within 21 days of emergency department presentation

Population: 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.

Outcome measures

Outcome measures
Measure	Derivation Cohort n=11857 Participants The derivation cohort collected data to derive the clinical decision rule.	Validation Cohort n=10573 Participants The validation cohort collected data to validate the clinical decision rule
Cervical Spine Injury	274 Participants	159 Participants

Adverse Events

Derivation Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 60 deaths

Validation Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 54 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julie C. Leonard, MD MPH

Nationwide Children's Hospital

Phone: 6143555856

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place