Recruiting

Observational StudySudden Unexplained Death in Childhood (SUDC) Registry

Sponsor:

NYU Langone Health

Code:

NCT03109197

Conditions

Sudden Unexplained Death Syndrome

Sudden Unexplained Death in Childhood

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Interventions

Biospecimin Collection

Study Details

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.

Conditions

Sudden Unexplained Death Syndrome

Sudden Unexplained Death in Childhood

Study ID

NCT03109197

Start date

Oct 1, 2014

Status verified date

Aug, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1600 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Biospecimin Collection

Primary outcome measure

Risks factors leading to sudden unexplained death in childhood (SUDC) collected from PHI [ Time Frame: 5 Years ]

Central Contacts and Locations

Central contacts

Laura Gould

laura.gould@nyulangone.org

Locations

New York University School of Medicine

Recruiting

New York, New York, United States, 10016

Contacts

Laura Crandall

laura.crandall@nyumc.org

Principal Investigator:

Orin Devinsky, MD

More Information

Sponsor

NYU Langone Health

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-08-28.