Post-mortem Genetic Testing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sudhin Thayyil, Thayyil, Sudhin
ClinicalTrials.gov Identifier:
NCT01120886
First received: May 7, 2010
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

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


Condition
Cardiac Ion Channelopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-mortem Genetic Testing for Cardiac Ion Channelopathy in Unexplained Still Births

Resource links provided by NLM:


Further study details as provided by Thayyil, Sudhin:

Primary Outcome Measures:
  • Incidence of cardiac ion channelopathy mutation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of cardiac ion channelopathy in 1st degree relatives of index case [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Skin and muscle


Estimated Enrollment: 100
Study Start Date: January 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   24 Weeks to 42 Weeks
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120886

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

No publications provided

Responsible Party: Sudhin Thayyil, Consultant Neonatologist, Thayyil, Sudhin
ClinicalTrials.gov Identifier: NCT01120886     History of Changes
Other Study ID Numbers: 48699
Study First Received: May 7, 2010
Last Updated: April 19, 2013
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Channelopathies
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014