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NCT Number: NCT03109197

Sudden Unexplained Death in Childhood (SUDC) Registry

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.

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Key information

Age range

11 month–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

New York University School of Medicine

New York, 10016, United States

Location status: Recruiting

Location contact

Laura Crandall

CONTACT

[email protected]

Orin Devinsky, MD

PRINCIPAL_INVESTIGATOR

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biospecimin Collection

Other

Primary outcomes

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

    Time frame: 5 Years

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Gould

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Columbia University
  • Mayo Clinic

Registry information

Official study title

The SUDC Registry and Research Collaborative

Acronym: SUDC

Important dates

Study start
2014
Primary completion
2028
Study completion
2028
First posted
Apr 12, 2017
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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