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The Paediatric Virtual Autopsy Trial

Primary Purpose

Stillbirth, Newborn Death, Sudden Infant Death

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Minimally invasive, virtual autopsy
Conventional autopsy
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stillbirth focused on measuring Autopsy, Minimally invasive, Foetuses, Newborns, Children, Adolescents

Eligibility Criteria

undefined - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Zurich, Division of Neonatology
  • Division of obstetrics, University Hospital Zurich
  • University Children's Hospital Zurich
  • Zurich Institute for Forensic Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Foetuses

Newborns

Children and adolescents

Arm Description

still birth and termination of pregnancies intervention: minimally invasive, virtual autopsy

who died of natural- and non-natural cause intervention: minimally invasive, virtual autopsy

who died of natural- and non-natural cause intervention: minimally invasive, virtual autopsy

Outcomes

Primary Outcome Measures

Percentage of cases for which virtual autopsy correctly identifies the cause of death and/or major pathological lesions
The diagnoses established in both ways by the two independent teams will be compared, the autopsy results being the gold standard. The primary outcome will be the percentage of cases for which virtual autopsy correctly identifies the diagnostic category.

Secondary Outcome Measures

Clinical indication
Number of false positive and false negative results of virtual autopsy will be calculated for each organ system.
MR Protocol
To optimize a protocol for MR imaging examinations in deceased foetuses, neonates, infants and children
Change in the ante-mortem diagnosis
The proportion of cases, for which virtual autopsy leaded to a change in ante-mortem diagnosis, will be reported.

Full Information

First Posted
June 17, 2013
Last Updated
January 7, 2021
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01888380
Brief Title
The Paediatric Virtual Autopsy Trial
Official Title
Post-mortem Cross-sectional Imaging With Guided Biopsy; A Comparative Study With Conventional Autopsy in Foetuses, Neonates, Infants and Children
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stillbirth, Newborn Death, Sudden Infant Death
Keywords
Autopsy, Minimally invasive, Foetuses, Newborns, Children, Adolescents

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Foetuses
Arm Type
Experimental
Arm Description
still birth and termination of pregnancies intervention: minimally invasive, virtual autopsy
Arm Title
Newborns
Arm Type
Experimental
Arm Description
who died of natural- and non-natural cause intervention: minimally invasive, virtual autopsy
Arm Title
Children and adolescents
Arm Type
Experimental
Arm Description
who died of natural- and non-natural cause intervention: minimally invasive, virtual autopsy
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive, virtual autopsy
Other Intervention Name(s)
Virtopsy
Intervention Description
Post-mortem cross-sectional imaging with CT-guided biopsy
Intervention Type
Procedure
Intervention Name(s)
Conventional autopsy
Other Intervention Name(s)
Postmortem
Primary Outcome Measure Information:
Title
Percentage of cases for which virtual autopsy correctly identifies the cause of death and/or major pathological lesions
Description
The diagnoses established in both ways by the two independent teams will be compared, the autopsy results being the gold standard. The primary outcome will be the percentage of cases for which virtual autopsy correctly identifies the diagnostic category.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Clinical indication
Description
Number of false positive and false negative results of virtual autopsy will be calculated for each organ system.
Time Frame
8 weeks
Title
MR Protocol
Description
To optimize a protocol for MR imaging examinations in deceased foetuses, neonates, infants and children
Time Frame
8 weeks
Title
Change in the ante-mortem diagnosis
Description
The proportion of cases, for which virtual autopsy leaded to a change in ante-mortem diagnosis, will be reported.
Time Frame
8 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Ulrich Bucher, MD, Prof
Organizational Affiliation
University Hospital Zurich, Division of Neonatology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christoph Rüegger, MD
Organizational Affiliation
University Hospital Zurich, Division of Neonatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Division of Neonatology
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Division of obstetrics, University Hospital Zurich
City
Zurich
Country
Switzerland
Facility Name
University Children's Hospital Zurich
City
Zurich
Country
Switzerland
Facility Name
Zurich Institute for Forensic Medicine
City
Zurich
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
35918685
Citation
Ruegger CM, Gascho D, Bode PK, Bruder E, Haslinger C, Ross S, Schmid K, Knopfli C, Hofer LJ, Held L, Martinez RM, Bucher HU; Virtopsy Study Group. Post-mortem magnetic resonance imaging with computed tomography-guided biopsy for foetuses and infants: a prospective, multicentre, cross-sectional study. BMC Pediatr. 2022 Aug 3;22(1):464. doi: 10.1186/s12887-022-03519-4.
Results Reference
derived
PubMed Identifier
24438163
Citation
Ruegger CM, Bartsch C, Martinez RM, Ross S, Bolliger SA, Koller B, Held L, Bruder E, Bode PK, Caduff R, Frey B, Schaffer L, Bucher HU. Minimally invasive, imaging guided virtual autopsy compared to conventional autopsy in foetal, newborn and infant cases: study protocol for the paediatric virtual autopsy trial. BMC Pediatr. 2014 Jan 20;14:15. doi: 10.1186/1471-2431-14-15.
Results Reference
derived

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The Paediatric Virtual Autopsy Trial

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