Clinical trial Recruiting at 14 sites Observational

Identifying genetic factors linked to unexpected infant deaths

Official title: Risk Stratification of Sudden Unexpected Death in Infant Based on Biomarkers - Identification of Genetic Variants Associated With Unexpected Infant Death Syndrome

Run by Nantes University Hospital · NCT06244433 · Data updated 2026-11-12

This study is trying to find new genetic links to sudden infant death syndrome (SIDS) by looking at the DNA of babies who have died unexpectedly and their parents.

Quick facts

Study typeObservational
SexAll
Enrollment650 (estimated)
SponsorNantes University Hospital
Academic / other
Locations18 sites (Nantes, Loire-Atlantique and 17 other locations)
StatusRecruiting
StartedAugust 27, 2024
Main results expectedAugust 27, 2026
Study endsOctober 27, 2027
Registry record updatedJune 18, 2026
Trial IDNCT06244433 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include infants aged 0 to 2 years who have experienced sudden unexpected death and their biological parents.

Probably not a fit

Patients with known metabolic, genetic, or syndromic pathologies at the time of death will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter genetic study aims to identify new genetic variants associated with sudden infant death syndrome (SIDS) through whole-genome sequencing of family trios. The study will include cases of sudden unexpected death in infants (SUDI) both retrospectively from a national registry and prospectively at referral centers. Whole genome sequencing will be performed on identified SIDS cases and their biological parents to analyze potential pathogenic allelic variants. The research is part of a larger project exploring genetics, neurobiology, and radio-anatomy related to SUDI.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of genetic factors contributing to SIDS, potentially informing prevention strategies.

How similar studies have gone: Other studies exploring genetic factors in SIDS have shown promise, but this specific approach using whole-genome sequencing is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Child Inclusion Criteria

* Death of a child between 0 and 2 years of age due to sudden unexpected death in infant
* Child included in the French SUDI registry with effective participation in the biocollection
* Children who also meet the inclusion criteria for the BIOMINRISK-NEUROBIO (axis 2) and BIOMINRISK-RADIO-ANAT (axis 3) studies in the overall BIOMINRISK project.

Parents Inclusion Criteria

* Biological parents of the child included in the BIOMINRISK study
* Parents who have both signed the consent form for blood collection and inclusion of their samples in the biocollection
* parents beneficiaries of a social security or similar scheme

Child Exclusion Criteria:

* Presence of a known metabolic, genetic or syndromic pathology at the time of death

Parents Exclusion Crtiteria:

* Parent under guardianship
* Presence of a known metabolic, genetic or syndromic pathology

Where it's running

  • Nantes University Hospital
    Nantes, Loire-Atlantique, France
    Recruiting
  • CHU Amiens
    Amiens, France
    Recruiting
  • CHU Angers
    Angers, France
    Recruiting
  • CHU Besançon
    Besançon, France
    Recruiting
  • APHP - Hôpital Jean Verdier
    Bondy, France
    Recruiting
  • CHU Brest
    Brest, France
    Recruiting
Show 12 more locations
  • APHP - Hôpital Antoine Béclère
    Clamart, France
    Recruiting
  • CHU Grenoble
    Grenoble, France
    Recruiting
  • Hcl
    Lyon, France
    Recruiting
  • CHU Montpellier
    Montpellier, France
    Recruiting
  • CHRU Nancy
    Nancy, France
    Recruiting
  • CHU Rouen
    Rouen, France
    Recruiting
  • CHU Saint Etienne
    Saint-Etienne, France
    Recruiting
  • CHU Toulouse
    Toulouse, France
    Recruiting
  • CHU de Caen-Normandie
    Caen, France
    Not yet recruiting
  • Centre Hospitalier Sud Francilien
    Corbeil-Essonnes, France
    Not yet recruiting
  • Ap-Hm
    Marseille, France
    Not yet recruiting
  • CHU de Poitiers
    Poitiers, France
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Improving counseling about safe sleep for infants using electronic records

    This study is testing a new tool to help pediatricians talk to parents about safe sleep for their babies during check-ups to reduce the risk of Sudden Infant Death Syndrome (SIDS).

    Recruiting Johns Hopkins University · Baltimore, Maryland · NCT05503771

  • Monitoring vital signs of newborns using advanced wireless sensors

    This study is testing a new wireless sensor to see if it can safely and accurately monitor the vital signs of healthy newborns during their first two hours after birth compared to the traditional wired system.

    Recruiting at 2 sites McGill University Health Centre/Research Institute of the McGill University Health Centre · Londrina, Paraná and 4 other locations · NCT06693817

  • TodaysBaby mobile safe-sleep support for new parents

    This program tests the TodaysBaby mobile safe-sleep messaging for parents of healthy, full-term newborns to see if it improves safe sleep practices and reaches families equally across income and race/ethnicity.

    Recruiting University of Virginia · Boston, Massachusetts · NCT06618586

  • Monitoring fetal heart activity in high-risk pregnancies to prevent stillbirth

    This study is testing a new way to monitor fetal heart activity in high-risk pregnancies to see if it can help prevent stillbirth.

    Recruiting at 2 sites Medical College of Wisconsin · Madison, Wisconsin and 1 other locations · NCT03775954

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.