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RecruitingNCT03109197SUDCUpdated Aug 28, 2026

Sudden Unexplained Death in Childhood (SUDC) Registry

An observational study in Sudden Unexplained Death Syndrome and Sudden Unexplained Death in Childhood, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 11 Months to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by NYU Langone Health · Observational

Study type
Observational
Model
Family-based
Time perspective
Prospective
Enrollment
1,600
Ages
11 Months to 100 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Sudden Unexplained Death Syndrome
  • Sudden Unexplained Death in Childhood

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03

Who can participate

Ages eligible
11 Months to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.

04

Study design

Observational model
Family-based
Time perspective
Prospective
Enrollment
1,600 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

    Other: Biospecimin Collection

  • 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.

    Other: Biospecimin Collection

Interventions

  • OtherBiospecimin Collection
05

What researchers measure

Primary outcomes

  1. Risks factors leading to sudden unexplained death in childhood (SUDC) collected from PHI

    Time frame: 5 Years

06

Study locations

1 of 1 sites recruiting
  • New York University School of Medicine
    New York, New York 10016, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT03109197
Lead sponsor
NYU Langone Health
Collaborators
Columbia University, Mayo Clinic
Responsible party
Sponsor
First posted
Apr 12, 2017
Start date
Oct 1, 2014
Primary completion
Nov 30, 2028 (estimated)
Completion
Nov 30, 2028 (estimated)
Last update
Aug 28, 2026

Study contacts

Laura Gould
Contact
laura.gould@nyulangone.org
Orrin Devinsky, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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