Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06244433
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2024-01-25
Brief Title:
Identification of Genetic Variants Associated With Unexpected Infant Death Syndrome
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Risk Stratification of Sudden Unexpected Death in Infant Based on Biomarkers - Identification of Genetic Variants Associated With Unexpected Infant Death Syndrome
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOMINRISK
Brief Summary:
This is a multicenter genetic study aimed at identifying new genesvariants associated with sudden infant death syndrome SIDS based on whole-genome sequencing of family trios
Detailed 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 ie variants present in the infant who died of SIDS and absent from the genome of both parents
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 ie variants present in the infant who died of SIDS and absent from the genome of both parents
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None