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Post-mortem Genetic Testing

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ClinicalTrials.gov Identifier: NCT01120886
Recruitment Status : Completed
First Posted : May 11, 2010
Last Update Posted : April 22, 2013
Sponsor:
Information provided by (Responsible Party):
Sudhin Thayyil, Thayyil, Sudhin

Brief Summary:
This is a prospective observational study to examine the incidence of cardiac ion channelopathies in unexplained still births.

Condition or disease
Cardiac Ion Channelopathy

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-mortem Genetic Testing for Cardiac Ion Channelopathy in Unexplained Still Births
Study Start Date : January 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Incidence of cardiac ion channelopathy mutation [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Incidence of cardiac ion channelopathy in 1st degree relatives of index case [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
Skin and muscle


Information from the National Library of Medicine

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Ages Eligible for Study:   24 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Unexplained still births
Criteria

Inclusion Criteria:

  • Unexplained still births,
  • No cause of death after detailed autopsy

Exclusion Criteria:

  • Lack of parental consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120886


Locations
United Kingdom
Great Ormond Street Hospital
London, United Kingdom
Southampton University Hospital
Southampton, United Kingdom
Sponsors and Collaborators
Thayyil, Sudhin

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sudhin Thayyil, Consultant Neonatologist, Thayyil, Sudhin
ClinicalTrials.gov Identifier: NCT01120886     History of Changes
Other Study ID Numbers: 48699
First Posted: May 11, 2010    Key Record Dates
Last Update Posted: April 22, 2013
Last Verified: April 2013

Keywords provided by Sudhin Thayyil, Thayyil, Sudhin:
Ion channelopathy,
Still birth
Sudden death

Additional relevant MeSH terms:
Channelopathies
Pathologic Processes