Whole-Body MRI in Suspected Victims of Abusive Head Trauma | NCT02309216

Studies
Whole-Body MRI in Suspected Victims of Abusive Head Trauma

NCT02309216

Sponsor

The University of Texas Health Science Center, Houston

Status

Completed

Last Update Posted

May 10, 2017Actual

Enrollment

8Actual

Phase

Not provided

Conditions

Shaken Baby Syndrome

Interventions

Whol-Body MRI scan

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

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Dec 1, 2014

First Submission Date that Met QC Criteria

Dec 2, 2014

First Posted Date

Dec 5, 2014Estimated

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

May 8, 2017

Last Update Posted Date

May 10, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Susan Wootton, Associate Professor, The University of Texas Health Science Center, HoustonPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose: to pilot whole-body MRI scanning in infants who are already getting brain MRI for suspected child abuse

Research design: prospective, blinded reading of Whole-Body MRI (WB-MRI) images during the routine care of the hospitalized infant with comparison to routine radiographic skeletal survey images

Procedures to be used: whole-body MRI images

Risks and potential benefits: no additional risk (the infant will be receiving and MRI of their brain as part of routine care, the additional images will be obtained at the same time without additional sedation); benefits to the infant include the identification of injuries which would have otherwise been missed by routine care importance of knowledge that may reasonably be expected to result: results from this study will potentially influence the use of radiographic skeletal survey and decrease the radiation exposure to infants being evaluated for suspected child abuse.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Name	Type	Description	Arm Group Labels	Other Names
Whol-Body MRI scan	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MRI findings of skeletal injuries, soft tissue injuries or visceral injuries	Whole Body MRI images will be read by a masked pediatric radiologist and compared with findings obtained by routine imaging and clinical evaluation	During hospitalization; MRI will typically be obtained on hospitalization day #2

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

younger than 12 months
admitted to the hospital
getting an MRI for suspected abusive head trauma

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

12 Months

Standard Ages

Child

Study Population

Infant inpatients being evaluated for suspected abusive head trauma who are already getting an MRI of the head and cervical spine.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas Health Science Center at Houston		Houston	Texas	77030	United States

Condition Browse Module

MeSH Terms

ID	Term
D038642	Shaken Baby Syndrome

Ancestor Terms

ID	Term
D001930	Brain Injuries
D006259	Craniocerebral Trauma
D020196	Trauma, Nervous System
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided