The SUDC Registry and Research Collaborative

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

The purpose is to increase the understanding of the characteristics, circumstances, medical histories and pathologies of children from ages 11 months through 18 years who have died suddenly and unexpectedly, and in some instances, without explanation. The SUDC Registry and Research Collaborative will analyze cases of sudden unexpected deaths in these children to understand risk factors and causes, and develop preventative measures.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 11 months
Maximum Age: 100
Healthy Volunteers: t
View:

⁃ Retrospective SUDC Cases

• 11months to 18 years of age.

• Subjects whose cause of death was sudden and unexplained-Postinfancy SIDS, Sudden Death of Childhood, Undetermined, Late SIDS, a vague description of symptoms of undetermined etiology, or a diagnosis acknowledged to be speculative by the prosecting pathologist

• If the retrospective case has banked DNA specimens.

⁃ Prospective SUDC Cases

• SUDC cases, parents and eligible family members from 11months-100 years of age.

• SUDC Subjects whose death was sudden and unexplained after the initial autopsy, and in whom a scene investigation and full autopsy was performed.

⁃ Family Members Subjects

• If the SUDC case has DNA viable specimens, family members will be asked if they would also like to participate in the DNA portion. One or both biological parents if willing and able will be considered as a family subject.

• Biological siblings and second degree relatives from age of 0-100 years of age that have had a history or currently have a heart condition and/or neurology condition.

Locations
United States
New York
New York University School of Medicine
RECRUITING
New York
Contact Information
Primary
Laura Gould
laura.gould@nyulangone.org
Time Frame
Start Date: 2014-10-01
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 1600
Treatments
Retrospective SUDC cases
All child biospecimens (including mucosal swab or blood samples for DNA analysis, pathology slides, tissue blocks, tissue samples or organs retained at autopsy) will be transferred to NYU Biorepository
Prospective SUDC cases
Heart and brain tissue will undergo full cardiac pathology consultation or neuropathology consultation will be transferred to pathologists at NYU or Mayo (based on pathologist availability). The PHI will remain intact in these cases since they will need to know how to identify the deceased with the medical records they receive and to complete the entire investigation thoroughly. A full consultation report will be sent back to Dr. Orrin Devinsky and tissue will be returned to the NYU biorepository upon completion of the cardiac or neuropathology consultation.
Related Therapeutic Areas
Sponsors
Collaborators: Mayo Clinic, Columbia University
Leads: NYU Langone Health

This content was sourced from clinicaltrials.gov