Identification of Genetic Variants Associated With Unexpected Infant Death Syndrome

Last updated: January 29, 2025
Sponsor: Nantes University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

whole genome sequencing

Clinical Study ID

NCT06244433
RC23_0260
  • All Genders

Study Summary

This is a multicenter genetic study aimed at identifying new genes/variants associated with sudden infant death syndrome (SIDS) based on whole-genome sequencing of family trios

Eligibility Criteria

Inclusion

Child Inclusion Criteria

  • Death of a child between 0 and 2 years of age due to sudden unexpected death ininfant

  • Child included in the French SUDI registry with effective participation in thebiocollection

  • 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 oftheir samples in the biocollection

  • parents beneficiaries of a social security or similar scheme

Exclusion

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

Study Design

Total Participants: 650
Treatment Group(s): 1
Primary Treatment: whole genome sequencing
Phase:
Study Start date:
August 27, 2024
Estimated Completion Date:
October 31, 2027

Study Description

The present project is part of a more global project called BIOMINRISK for which 3 axes will be explored: Genetics (a project which will be detailed here), Neurobiology and Radio-anatomical.

This is a multicenter (15 centers), national, non-randomized, open-label, genetic study. Sudden unexpected death in infant (SUDI) cases will be included (i) partly retrospectively (infants already included in the national French SUDI registry) and (ii) for the other cases, prospectively at the time of care of the deceased infant by the referral center of SUDI participating in the project. The parents making up the trios will be included prospectively.

Once the Sudden infant death syndrome (SIDS) cases have been identified among all the included SUDI cases (following the results of post-mortem examinations), Whole Genome Sequencing (WGS) will be carried out on these SIDS cases and their two parents, in order to identify pathogenic allelic variants. The data generated by this sequencing will then be analyzed using a trio approach to search for de novo variants, i.e. variants present in the infant who died of SIDS and absent from the genome of both parents.

Connect with a study center

  • Nantes University Hospital

    Nantes, Loire-Atlantique 44093
    France

    Active - Recruiting

  • CHU Amiens

    Amiens,
    France

    Active - Recruiting

  • CHU Angers

    Angers,
    France

    Active - Recruiting

  • CHU Besançon

    Besançon,
    France

    Active - Recruiting

  • APHP - Hôpital Jean Verdier

    Bondy,
    France

    Active - Recruiting

  • CHU Brest

    Brest,
    France

    Active - Recruiting

  • APHP - Hôpital Antoine Béclère

    Clamart,
    France

    Active - Recruiting

  • CHU Grenoble

    Grenoble,
    France

    Active - Recruiting

  • HCL

    Lyon,
    France

    Active - Recruiting

  • AP-HM

    Marseille,
    France

    Site Not Available

  • CHU Montpellier

    Montpellier,
    France

    Active - Recruiting

  • CHRU Nancy

    Nancy,
    France

    Active - Recruiting

  • CHU Rouen

    Rouen,
    France

    Active - Recruiting

  • CHU Saint Etienne

    Saint-Étienne,
    France

    Active - Recruiting

  • CHU Toulouse

    Toulouse,
    France

    Active - Recruiting

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