Clinical trial NCT03109197: Sudden Unexplained Death in Childhood (SUDC) Registry
Official title: The SUDC Registry and Research Collaborative
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sudden Unexplained Death Syndrome
Sudden Unexplained Death in Childhood
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Mayo Clinic
First posted: 2017-04-12
Enrollment: 1600
Sex: ALL
Minimum age (years): 11
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1300 participants (400 SUDC subjects and 800 parents, and approximately 100 siblings or symptomatic second degree relatives) over a period of 5 years, including both retrospectively and prospectively ascertained cases.

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.

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.

Primary outcomes:
measure: Risks factors leading to sudden unexplained death in childhood (SUDC) collected from PHI
timeFrame: 5 Years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Orrin Devinsky, MD
role: PRINCIPAL_INVESTIGATOR
References: