Identifying genetic factors linked to unexpected infant deaths
Risk Stratification of Sudden Unexpected Death in Infant Based on Biomarkers - Identification of Genetic Variants Associated With Unexpected Infant Death Syndrome
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 type | Observational |
|---|---|
| Enrollment | 650 (estimated) |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 15 sites (Nantes, Loire-Atlantique and 14 other locations) |
| Trial ID | NCT06244433 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include infants aged 0 to 2 years who have experienced sudden unexpected death and their biological parents.
Not a fit: Patients with known metabolic, genetic, or syndromic pathologies at the time of death will not benefit from this study.
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 performed: Other studies exploring genetic factors in SIDS have shown promise, but this specific approach using whole-genome sequencing is relatively novel.
Eligibility criteria
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 this trial is running
Nantes, Loire-Atlantique and 14 other locations
- 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)
- APHP - Hôpital Antoine Béclère — Clamart, France (Recruiting)
- CHU Grenoble — Grenoble, France (Recruiting)
- Hcl — Lyon, France (Recruiting)
- Ap-Hm — Marseille, France (Not_yet_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)
Study contacts
- Principal investigator: Fleur Lorton — Nantes University Hospital
- Study coordinator: Fleur Lorton
- Email: Fleur.LORTON@chu-nantes.fr
- Phone: 33 2 40 08 38 06
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.