Whole-Body MRI in Suspected Victims of Abusive Head Trauma

Shaken Baby Syndrome Clinical Trial

Official title:

Whole-Body MRI in Suspected Victims of Abusive Head Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02309216
• Other study ID #: HSC-MS-14-0715
• Status: Completed
• Phase: N/A
• First received: December 1, 2014
• Last updated: May 8, 2017
• Start date: November 2014
• Est. completion date: January 2016

Study information

• Verified date: May 2017
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

• younger than 12 months

• admitted to the hospital

• getting an MRI for suspected abusive head trauma

Exclusion Criteria:

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Shaken Baby Syndrome

Intervention

Other:
• Whol-Body MRI scan

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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