Sudden Unexplained Death in Childhood (SUDC) Registry

NYU Langone Health

Status: Enrolling

Conditions: Sudden Unexplained Death Syndrome; Sudden Unexplained Death in Childhood

Treatments: Other: Biospecimin Collection

Study type: Observational

Funder types: Other

Identifiers

NCT03109197

14-01061

Details and patient eligibility

About

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.

Full description

• Review the child's death, medical and family history by our study pathologists (including forensic, pediatric, cardiac and neuropathologists) to determine whether a possible, probable or definite cause of death can be identified and whether additional studies might be helpful in determining a specific cause of death.
• For case investigations that are open/active, the registry offers cardiac pathology, and neuroimaging/neuropathology consultations.
• For those cases determined to be unexplained/undetermined- access to genetic analysis (whole exome sequencing) when viable samples are available. Additional genetic analysis opportunities for biological parents and some family members. For more information, please see our Genetics Frequently Asked Questions.
• Study the risks that lead to sudden unexplained death in childhood (SUDC).
• Provide families with a review of their child's death through a case review report.
• Identify at-risk individuals with the hopes of gaining knowledge to establish prevention strategies to reduce the chances of sudden unexplained death in the future.

Enrollment: 1,600 estimated patients

Sex: All

Ages: 11 months to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

SUDC Subjects

• Subjects that are younger than 11months or older than 18 years of age will be excluded as a SUDC case.
• Prospective SUDC cases of apparent suicide, homicide, and accident where the external cause was the obvious and only reason for the death will be excluded from this study.

Family Member Subjects Any siblings or second degree family relatives that did not have a history or current heart or neurology condition will not be able to enroll in the study.

Trial design

1,600 participants in 2 patient groups

Retrospective SUDC cases

Description:

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

Treatment:

Other: Biospecimin Collection

Prospective SUDC cases

Description:

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.

Treatment:

Other: Biospecimin Collection