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Completed

NCT Number: NCT01743703

Utility of Whole-body MRI in the Detection of Traumatic Injuries of Undetermined Origin in Children

The diagnosis of abuse in children relies heavily on the presence of skeletal and extraskeletal injuries. However, some lesions are not seen by initial skeletal survey. And the investigators have to complete the skeletal survey with either bone-scan or CT scan or whole-body MRI. whole-body MRI has proved its worth in the pediatric population for the evaluation of skeletal and extraskeletal lesions in children with cancer or infectious diseases. Thus, whole-body MRI would allowed to have total picture of children without ionising radiation exposure.

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Key information

Conditions

Traumatic Injuries Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

Up to 3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Rennes

Rennes, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infant hospitalised for sub-dural hematoma or skeletal injuries due to non accidental traumatism or skin lesions or abdominal injuries of undetermined origin

Exclusion criteria

  • Sub-dural hematoma of accidental origin or skeletal injuries of accidental
  • Origin or known origin of lesions.
  • Subject already included in the study

Treatment and study plan

diagnostic whole body MRI

Other

diagnostic whole body MRI, both STIR and diffusion weighted

Primary outcomes

  1. sensibility of MRI for detecting skeletal injuries

    Time frame: one week

    standard skeletal imaging is used as reference

  2. positive predictive value of MRI for detecting skeletal injuries

    Time frame: one week

    standard skeletal imaging is used as reference

Secondary outcomes

  1. sensibility of MRI for detecting children with skeletal injuries

    Time frame: one week

    standard skeletal imaging is used as reference

  2. specificity of MRI for detecting children with skeletal injuries

    Time frame: one week

    standard skeletal imaging is used as reference

  3. predictive positive value of MRI for detecting children with skeletal injuries

    Time frame: one week

    standard skeletal imaging is used as reference

  4. predictive negative value of MRI for detecting children with skeletal injuries

    Time frame: one week

    standard skeletal imaging is used as reference

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

Utility of Whole-body MRI (STIR and Diffusion Weighted) in the Detection of Traumatic Injuries of Undetermined Origin in Children

Acronym: PEDIMA

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Dec 6, 2012
Registry last updated
May 24, 2023

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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