Registry for understanding sudden unexplained deaths in children
The SUDC Registry and Research Collaborative
This study is trying to understand sudden unexplained deaths in children by looking closely at their medical histories and circumstances to help find causes and prevent future tragedies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1600 (estimated) |
| Ages | 11 Months to 100 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT03109197 on ClinicalTrials.gov |
What this trial studies
This registry aims to enhance the understanding of sudden unexplained deaths in children aged 11 months to 18 years by analyzing their medical histories, circumstances, and pathologies. The study involves a thorough review of each child's case by specialized pathologists to identify potential causes of death and assess risk factors. It also offers genetic analysis for cases deemed unexplained, with the goal of developing preventative strategies to reduce future occurrences. Families will receive a detailed report on their child's case to aid in understanding and closure.
Who should consider this trial
Good fit: Ideal candidates include children aged 11 months to 18 years who have experienced sudden and unexplained deaths, as well as their family members for genetic analysis.
Not a fit: Patients who have a clear and identifiable cause of death will not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved understanding and prevention of sudden unexplained deaths in children.
How similar studies have performed: While studies on sudden unexplained deaths exist, this registry represents a novel approach focused specifically on childhood cases and their genetic underpinnings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- New York University School of Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Orrin Devinsky, MD — NYU Langone Health
- Study coordinator: Laura Gould
- Email: laura.gould@nyulangone.org
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.