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OpenTrials
Completed

NCT Number: NCT02309216

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.

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Key information

Conditions

Shaken Baby Syndrome Brain Injuries Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Whol-Body MRI scan

Other

Primary outcomes

  1. MRI findings of skeletal injuries, soft tissue injuries or visceral injuries

    Time frame: During hospitalization; MRI will typically be obtained on hospitalization day #2

    Whole Body MRI images will be read by a masked pediatric radiologist and compared with findings obtained by routine imaging and clinical evaluation

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 5, 2014
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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