Sudden Unexplained Death in Childhood (SUDC) Registry

NCT ID: NCT03109197

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-01
• Study Completion Date: 2028-11-30

Brief 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.

Detailed 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.

Conditions

Sudden Unexplained Death Syndrome; Sudden Unexplained Death in Childhood

Study Design

• Observational Model Type: FAMILY_BASED
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Biospecimin Collection

Intervention Type: OTHER

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.

Biospecimin Collection

Intervention Type: OTHER

Interventions

Biospecimin Collection

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 11 Months
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Orrin Devinsky, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Laura Gould

Role: CONTACT

laura.gould@nyulangone.org

Facility Contacts

Laura Crandall

Role: primary

laura.crandall@nyumc.org

Other Identifiers

14-01061

Identifier Type: -

Identifier Source: org_study_id