Identification of Genetic Variants Associated With Unexpected Infant Death Syndrome

Sudden Infant Death Clinical Trial

— BIOMINRISK  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06244433
• Other study ID #: RC23_0260
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: April 2027

Study information

• Verified date: January 2024
• Source: Nantes University Hospital
• Contact: Fleur Lorton
• Phone: 33 2 40 08 38 06
• Email: Fleur.LORTON[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 650
• Est. completion date: April 2027
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Infant Death
• Sudden Infant Death
• Sudden Unexplained Infant Death

Intervention

Genetic:
• whole genome sequencing
Study of all coding and non-coding sequences in the genome to identify pathogenic allelic variants

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes	Loire-Atlantique

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	AXA Assurances VIE Mutuelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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