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临床试验/NCT04237454
NCT04237454已完成不适用

Thermal Imaging Compared to Skeletal Survey for Diagnosis of Fractures in Suspected Inflicted Injury in Children Below 2 Years of Age: A Prospective Diagnostic Accuracy Study

Sheffield Children's NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2
试验地点
2
主要终点
Diagnostic accuracy of thermal imaging for fracture detection compared to skeletal survey as the gold standard

研究概览

简要总结

When a child less than 2 years old attends the Emergency Department (ED) with an injury, carers should offer an explanation. When there is no explanation or if the explanation is inconsistent & because the child cannot say what happened, the doctor will need to consider all possible causes including child abuse. To help exclude abuse, the doctor will request x-rays of all the child's bones to make sure there are no other unexplained fractures. This requires up to 20 x-rays, which are called a skeletal survey. Even if there are no fractures, some or all of the x-rays will be repeated in the following 7-21 days, because by that time any fractures will have started to heal and so are easier to see than on the first skeletal survey. It means that if a doctor is worried about abuse, the child may need to have up to 40 x-rays, which amounts to a significant radiation dose (more than 6 months of natural UK background radiation) & increases the child's lifetime risk of getting cancer. 79 to 97 out of 100 skeletal surveys performed are normal. While it is of paramount importance to identify if a child is being abused, it is also important to minimise radiation dose. A camera which detects light and heat given off by the body has shown promise in some areas of medical practice. We plan to compare the results from the camera to those of the skeletal survey in 40 children below 2 years of age attending our hospital over a 6-month period. We hope to demonstrate that this technology can be used to further select children who should have a skeletal survey, reducing radiation dose in children without missing those who are being abused and sending them home to be abused again.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
1 Month 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children between 1 month and 2 years of age having initial/follow-up skeletal survey for investigation of suspected abuse
  • Healthy Control children

排除标准

  • Informed consent withheld by main carer/guardian for the skeletal survey (court order would then be issues)
  • Informed consent for participation in the research study withheld
  • Situations where informed consent cannot be obtained (e.g. inability of carer/guardian to understand written English)
  • Postmortem cases (inclusion of the demised would unduly complicate the consent process for this small pilot study)

结局指标

主要结局

Diagnostic accuracy of thermal imaging for fracture detection compared to skeletal survey as the gold standard

时间窗: 6 months

Diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of thermal imaging compared to the full skeletal survey as gold standard

次要结局

  • Potential radiation dose reduction - calculated on the basis of known radiation exposure of the images that form the skeletal survey(6 months)
  • Carer acceptability/preference of the imaging modalities(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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