Pediatric Cervical Spine Clearance: A Multicenter Prospec... | NCT05608460

Studies
Pediatric Cervical Spine Clearance: A Multicenter Prospective Observational Study

NCT05608460

Sponsor

University of Utah

Status

Unknown status

Last Update Posted

Nov 8, 2022Actual

Enrollment

15,700Estimated

Phase

Not provided

Conditions

Cervical Spine Fracture

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 15, 2022Actual

Primary Completion Date

Aug 15, 2025Estimated

Completion Date

Aug 15, 2025Estimated

First Submitted Date

Nov 1, 2022

First Submission Date that Met QC Criteria

Nov 1, 2022

First Posted Date

Nov 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2022

Last Update Posted Date

Nov 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A prospective multicenter observational study, led by Dr. Katie Russell of Intermountain Primary Children's Hospital, that will examine the sensitivity, specificity, negative, and positive predictive values of CT scan and plain films in diagnosing cervical spine injury that requires treatment. This study is funded by the Primary Children's Hospital foundation.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15,700Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Predictive Values of CT, XR, and MRI	The sensitivity, specificity, negative and positive predictive values of CT, XR, and MRI for clinically significant injury will be calculated.	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any participant less than 18 years old after blunt trauma
Seen by trauma service
With cervical spine imaging (XR, CT, or MRI)

Exclusion Criteria:

CT scan from outside facility is poor quality and not repeated (<63-channel, cuts >3mm, no reformats, motion artifact)
No radiology over reads by participating institution

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Any participant less than 18 years old after blunt trauma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kezlyn Larsen, BS	Contact	801-662-2989		kezlyn.larsen@hsc.utah.edu

Overall Officials

Name	Affiliation	Role
Katie Russell, MD	University of Utah	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Phoenix Children's Hospital	Not yet recruiting	Phoenix	Arizona	85016	United States