The Paediatric Virtual Autopsy Trial

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)

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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