Identification of Genetic Variants Associated With Unexpected Infant Death Syndrome
BIOMINRISK
Risk Stratification of Sudden Unexpected Death in Infant Based on Biomarkers - Identification of Genetic Variants Associated With Unexpected Infant Death Syndrome
1 other identifier
observational
650
1 country
15
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2024
Typical duration for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2024
CompletedFirst Posted
Study publicly available on registry
February 6, 2024
CompletedStudy Start
First participant enrolled
August 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
January 31, 2025
September 1, 2024
1.9 years
January 25, 2024
January 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Identification of genetic variants
Presence of de novo genetic point mutations in coding and non-coding sequences, based on analysis of family trios using a whole-genome sequencing approach
up to 38 months
Secondary Outcomes (2)
Identification of heterozygous variants or CNVs (copy number variants)
up to 38 months
Identification of new genotype - phenotype correlations
up to 38 months
Study Arms (2)
SUDI cases
Sudden unexpected death in infant (SUDI) cases registered within the French National Registry of SUDI
Parents
Both parents of identified SUDI
Interventions
Study of all coding and non-coding sequences in the genome to identify pathogenic allelic variants
Eligibility Criteria
The population included will consist of infants who died in the context of SUDI and both their parents. These cases of SUDI will come from the French SUDI registry, which records all cases of SUDI occurring in children under 2 years of age throughout France via a network of referral centers for the management of SUDI.
You may qualify if:
- 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
- Biological parents of the child included in the BIOMINRISK study
- parents beneficiaries of a social security or similar scheme
You may not qualify if:
- Presence of a known metabolic, genetic or syndromic pathology at the time of death
- Parent under guardianship
- Presence of a known metabolic, genetic or syndromic pathology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nantes University Hospitallead
- AXA Assurances VIE Mutuellecollaborator
- Institut du Thoraxcollaborator
Study Sites (15)
Nantes University Hospital
Nantes, Loire-Atlantique, 44093, France
CHU Amiens
Amiens, France
CHU Angers
Angers, France
CHU Besançon
Besançon, France
APHP - Hôpital Jean Verdier
Bondy, France
CHU Brest
Brest, France
APHP - Hôpital Antoine Béclère
Clamart, France
CHU Grenoble
Grenoble, France
HCL
Lyon, France
AP-HM
Marseille, France
CHU Montpellier
Montpellier, France
CHRU Nancy
Nancy, France
CHU Rouen
Rouen, France
CHU Saint Etienne
Saint-Etienne, France
CHU Toulouse
Toulouse, France
Related Publications (1)
Ducloyer M, Baruteau AE, Franco P, Guyon A, Sapin V, Karakachoff M, Savall F, Schott JJ, de Pontual L, De Visme S, Ferrand L, Jarry B, Beudin D, Scherdel P, Lorton F. 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. BMJ Open. 2025 Jul 30;15(7):e101811. doi: 10.1136/bmjopen-2025-101811.
PMID: 40738637DERIVED
Biospecimen
blood and DNA samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fleur Lorton
Nantes University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- FAMILY BASED
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2024
First Posted
February 6, 2024
Study Start
August 27, 2024
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
October 1, 2027
Last Updated
January 31, 2025
Record last verified: 2024-09