Sudden Unexplained Death in Childhood (SUDC) Registry (SUDC)

October 29, 2025 updated by: NYU Langone Health

The SUDC Registry and Research Collaborative

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • New York University School of Medicine
        • Contact:
        • Principal Investigator:
          • Orin Devinsky, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 months to 100 years (Child, Adult, Older Adult)

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Family-Based
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Risks factors leading to sudden unexplained death in childhood (SUDC) collected from PHI
Time Frame: 5 Years
5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mayo Clinic
Columbia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Orrin Devinsky, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-01061

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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