Whole-Body MRI in Suspected Victims of Abusive Head Trauma

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.

Study Overview

• Status: Completed
• Conditions: Shaken Baby Syndrome
• Intervention / Treatment: Other: Whol-Body MRI scan

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (ACTUAL): January 1, 2016
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: December 1, 2014
• First Submitted That Met QC Criteria: December 2, 2014
• First Posted (ESTIMATE): December 5, 2014

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Brain Injuries; Craniocerebral Trauma; Shaken Baby Syndrome
• Other Study ID Numbers: HSC-MS-14-0715