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临床试验/NCT01417962
NCT01417962已完成不适用

Post Mortem Magnetic Resonance Imaging in the Fetus, Infant and Child: A Comparative Study With Conventional Autopsy

Thayyil, Sudhin2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2007年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
试验地点
2
主要终点
Number of cases where the cause of death and/or major pathological lesions are detected

研究概览

简要总结

The aim of this project is to establish whether magnetic resonance (MR) imaging can provide a minimally invasive approach for post-mortem assessment of the fetus, infant and child, with similar detection rates for anomalies and determination of the cause of death.

This will be achieved by acquiring a database of whole-body, post-mortem MR images in approximately 400 fetuses, infants and children, over a 3 years period. Images will be acquired on a dedicated 1.5T research MR scanner. MR images will be reported by an expert group of paediatric radiologists, and compared, in a blinded fashion, with reports from conventional autopsy performed by expert perinatal and paediatric pathologists. Importantly, the post-mortem information will be assessed with reference to the needs of the parents, referring clinicians and HM Coroners. The detection of central nervous system abnormalities will be assessed separately.

The study will be performed across two sites: A dedicated children's hospital (Great Ormond Street Hospital) and a teaching hospital, with large obstetric, fetal and neonatal departments (University College London Hospital), which are linked academically by University College London.

Co-ordination of the project will be managed by a steering committee, which will ensure accurate collation and comparison of the data.

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 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Fetuses, newborns and Infants undergoing conventional autopsy

排除标准

  • Lack of parental consent

结局指标

主要结局

Number of cases where the cause of death and/or major pathological lesions are detected

时间窗: 6 weeks

Conventional autopsy will be considered as the gold standard. The number (%) of cases where post-mortem MR imaging identifies the cause of death and/or major pathological lesions when compared with conventional autopsy will be reported

次要结局

  • MR appearance of death-induced artefacts.(6 weeks)
  • Number of cases where there is a change in ante-mortem diagnosis(6 weeks)

研究者

发起方
Thayyil, Sudhin
申办方类型
Indiv
责任方
Principal Investigator
主要研究者

Sudhin Thayyil

Consultant Neonatologist

Thayyil, Sudhin

研究点 (2)

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