The Paediatric Virtual Autopsy Trial

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Completed

Conditions

Newborn Death
Sudden Infant Death
Stillbirth

Treatments

Procedure: Minimally invasive, virtual autopsy
Procedure: Conventional autopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT01888380
Paediatric virtopsy

Details and patient eligibility

About

In light of declining autopsy rates around the world, post-mortem MR imaging is a promising alternative to conventional autopsy in the investigation of infant death. A major drawback of this non-invasive autopsy approach is the fact that histopathological and microbiological examination of the tissue is not possible. The objective of this prospective study is to compare the performance of minimally invasive, virtual autopsy, including CT-guided biopsy, with conventional autopsy procedures in a paediatric population. Foetuses, newborns, infants and children that are referred for autopsy at three different institutions associated with the University of Zurich will be eligible for recruitment. All bodies will be examined with a commercial CT and a 3 Tesla MRI scanner, and investigators will be blinded to the results of conventional autopsy. After cross-sectional imaging, CT-guided tissue sampling will be performed by a multifunctional robotic system (Virtobot) allowing for automated post-mortem biopsies. Virtual autopsy results will be classified with regards to the likely final diagnosis and major pathological findings and compared to the results of conventional autopsy, which remains the diagnostic gold standard. This interdisciplinary study will determine whether virtual autopsy will narrow the gap in information between non-invasive and traditional autopsy procedures.

Enrollment

105 patients

Sex

All

Ages

Under 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* Stillborn infants ≥ 16 0/7 weeks of gestational age (GA) * Live born infants ≥ 16 0/7 weeks GA until adolescents up to 16 years of age, who died of natural- and non-natural cause (trauma, homicide, suicide and intoxication).

Exclusion criteria

* Deceased infants who are donors of organs * Lack of parental consent

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

105 participants in 3 patient groups

Foetuses
Experimental group
Description:
still birth and termination of pregnancies intervention: minimally invasive, virtual autopsy
Treatment:
Procedure: Conventional autopsy
Procedure: Minimally invasive, virtual autopsy
Newborns
Experimental group
Description:
who died of natural- and non-natural cause intervention: minimally invasive, virtual autopsy
Treatment:
Procedure: Conventional autopsy
Procedure: Minimally invasive, virtual autopsy
Children and adolescents
Experimental group
Description:
who died of natural- and non-natural cause intervention: minimally invasive, virtual autopsy
Treatment:
Procedure: Conventional autopsy
Procedure: Minimally invasive, virtual autopsy

Trial contacts and locations

4

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems