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Clinical Trials/NCT01417962
NCT01417962
Completed
N/A

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

Thayyil, Sudhin2 sites in 1 country400 target enrollmentMarch 2007

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stillbirths
Sponsor
Thayyil, Sudhin
Enrollment
400
Locations
2
Primary Endpoint
Number of cases where the cause of death and/or major pathological lesions are detected
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 2007
End Date
September 2011
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Thayyil, Sudhin
Responsible Party
Principal Investigator
Principal Investigator

Sudhin Thayyil

Consultant Neonatologist

Thayyil, Sudhin

Eligibility Criteria

Inclusion Criteria

  • Fetuses, newborns and Infants undergoing conventional autopsy

Exclusion Criteria

  • Lack of parental consent

Outcomes

Primary Outcomes

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

Time Frame: 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

Secondary Outcomes

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

Study Sites (2)

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