NCT03109197 Sudden Unexplained Death in Childhood (SUDC) Registry
| NCT ID | NCT03109197 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Sudden Unexplained Death Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,600 participants |
| Start Date | 2014-10-01 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,600 participants in total. It began in 2014-10-01 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Laura Gould
✉ laura.gould@nyulangone.orgOrrin Devinsky, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT03109197 clinical trial?
This trial is open to participants of all sexes, aged 11 Months or older, up to 100 Years, studying Sudden Unexplained Death Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03109197 currently recruiting?
Yes, NCT03109197 is actively recruiting participants. Contact the research team at laura.gould@nyulangone.org for enrollment information.
Where is the NCT03109197 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT03109197 clinical trial?
NCT03109197 is sponsored by NYU Langone Health. The principal investigator is Orrin Devinsky, MD at NYU Langone Health. The trial plans to enroll 1,600 participants.