Actively Recruiting

All Genders
ID06244433

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

Led by Nantes University Hospital · Updated on 2026-05-08

650

Participants Needed

15

Research Sites

60 weeks

Total Duration

On this page

Sponsors

N

Nantes University Hospital

Lead Sponsor

A

AXA Assurances VIE Mutuelle

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a multicenter genetic study to find new gene variants linked to sudden infant death syndrome (SIDS) by analyzing the whole genomes of affected infants and their parents. This project is part of a larger study called BIOMINRISK, which also explores neurobiology and radio-anatomical aspects. The study includes cases of sudden unexpected death in infants (SUDI) both retrospectively from a national registry and prospectively through referral centers. The study involves whole genome sequencing of infants diagnosed with SIDS and their biological parents to identify harmful genetic variants. Researchers analyze the data using a trio approach to detect new genetic changes present in the infant but absent from both parents. This genetic analysis helps explore possible causes of SIDS by examining all coding and non-coding parts of the genome. Participants include infants who died suddenly and unexpectedly before age 2 and their biological parents. The study collects blood samples and genetic data, with consent from parents. Researchers will monitor genetic findings over about 38 months, looking for new genetic variants, copy number changes, and links between genetic profiles and physical traits. The study is observational and does not involve treatment, but aims to improve understanding of SIDS risks.

CONDITIONS

Brief Title

Identification of Genetic Variants Associated With Unexpected Infant Death Syndrome

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 and BIOMINRISK-RADIO-ANAT studies
  • 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
Not Eligible

You will not qualify if you...

  • Presence of a known metabolic, genetic or syndromic pathology at the time of death in the child
  • Parent under guardianship
  • Presence of a known metabolic, genetic or syndromic pathology in the parents

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Varies depending on timing of post-mortem results

Participants who are cases of sudden unexpected infant death undergo post-mortem examinations to identify sudden infant death syndrome (SIDS) among these cases.

1 visit (in-person)

Sample Collection

Duration - Up to 38 months

Whole genome sequencing samples are collected from identified SIDS cases and their biological parents to identify genetic variants.

1 to 2 visits depending on sample availability

Long-term Monitoring

Duration - Up to 38 months

Genetic data generated from sequencing is analyzed over time to identify pathogenic allelic variants and new genotype-phenotype correlations.

Additional assessments may occur depending on cohort assignment

Trial Site Locations

Total: 15 locations

1

Nantes University Hospital

Nantes, Loire-Atlantique, France, 44093

Actively Recruiting

2

CHU Amiens

Amiens, France

Actively Recruiting

3

CHU Angers

Angers, France

Actively Recruiting

4

CHU Besançon

Besançon, France

Actively Recruiting

5

APHP - Hôpital Jean Verdier

Bondy, France

Actively Recruiting

6

CHU Brest

Brest, France

Actively Recruiting

7

APHP - Hôpital Antoine Béclère

Clamart, France

Actively Recruiting

8

CHU Grenoble

Grenoble, France

Actively Recruiting

9

HCL

Lyon, France

Actively Recruiting

10

AP-HM

Marseille, France

Not Yet Recruiting

11

CHU Montpellier

Montpellier, France

Actively Recruiting

12

CHRU Nancy

Nancy, France

Actively Recruiting

13

CHU Rouen

Rouen, France

Actively Recruiting

14

CHU Saint Etienne

Saint-Etienne, France

Actively Recruiting

15

CHU Toulouse

Toulouse, France

Actively Recruiting

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Research Team

F

Fleur Lorton

A

Alban-Elouen BARUTEAU

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Identification of novel genetic, neurobiological and radio-anatomical biomarkers for risk stratification of sudden unexpected death in infancy and early childhood: the BIOMINRISK study protocol.

Mathilde Ducloyer, Alban-Elouen Baruteau, Patricia Franco...

https://pubmed.ncbi.nlm.nih.gov/40738637