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临床试验/NCT02309216
NCT02309216已完成不适用

Whole-Body MRI in Suspected Victims of Abusive Head Trauma

The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
MRI findings of skeletal injuries, soft tissue injuries or visceral injuries

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan Wootton

Associate Professor

The University of Texas Health Science Center, Houston

研究点 (1)

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