Trial record 9 of 12 for:    "Sudden infant death syndrome"

The Paediatric Virtual Autopsy Trial; Minimally Invasive, Imaging Guided Virtual Autopsy Compared to Conventional Autopsy

This study is currently recruiting participants.
Verified January 2014 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01888380
First received: June 17, 2013
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Stillbirth
Newborn Death
Sudden Infant Death
Procedure: Minimally invasive, virtual autopsy
Procedure: Conventional autopsy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Diagnostic
Official Title: Post-mortem Cross-sectional Imaging With Guided Biopsy; A Comparative Study With Conventional Autopsy in Foetuses, Neonates, Infants and Children

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Percentage of cases for which virtual autopsy correctly identifies the cause of death and/or major pathological lesions [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Number of false positive and false negative results of virtual autopsy will be calculated for each organ system.

  • MR Protocol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    To optimize a protocol for MR imaging examinations in deceased foetuses, neonates, infants and children

  • Change in the ante-mortem diagnosis [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The proportion of cases, for which virtual autopsy leaded to a change in ante-mortem diagnosis, will be reported.


Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Foetuses
Still birth and termination of pregnancies
Procedure: Minimally invasive, virtual autopsy Procedure: Conventional autopsy
Experimental: Newborns
Who died of natural- and non-natural cause
Procedure: Minimally invasive, virtual autopsy Procedure: Conventional autopsy
Experimental: Children and adolescents
Who died of natural- and non-natural cause
Procedure: Minimally invasive, virtual autopsy Procedure: Conventional autopsy

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01888380

Contacts
Contact: Christoph Rüegger, MD +41 44 255 16 08 christoph.rueegger@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Neonatology Recruiting
Zurich, ZH, Switzerland, 8091
Contact: Christoph Rüegger, MD       christoph.rueegger@usz.ch   
Principal Investigator: Christoph Rüegger, MD         
University Children's Hospital Zurich Recruiting
Zurich, Switzerland
Contact: Bernhard Frey, MD, Prof       bernhard.frey@kispi.uzh.ch   
Principal Investigator: Bernhard Frey, MD, Prof.         
Division of obstetrics, University Hospital Zurich Recruiting
Zurich, Switzerland
Contact: Leonhard Schäffer, MD       leonhard.schaeffer@usz.ch   
Principal Investigator: Leonhard Schäffer, MD         
Zurich Institute for Forensic Medicine Recruiting
Zurich, Switzerland
Contact: Christine Bartsch, MD       christine.bartsch@irm.uzh.ch   
Principal Investigator: Christine Bartsch, MD         
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: Hans Ulrich Bucher, MD, Prof University Hospital Zurich, Division of Neonatology
Principal Investigator: Christoph Rüegger, MD University Hospital Zurich, Division of Neonatology
  More Information

No publications provided by University of Zurich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01888380     History of Changes
Other Study ID Numbers: Paediatric virtopsy
Study First Received: June 17, 2013
Last Updated: January 20, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
Autopsy
Minimally invasive
Foetuses
Newborns
Children
Adolescents

Additional relevant MeSH terms:
Death
Sudden Infant Death
Pathologic Processes
Death, Sudden

ClinicalTrials.gov processed this record on April 17, 2014