Clinical trial NCT06708793: Environmental Exposures and Sudden Unexpected Infant Death
Official title: Environmental Exposures and Sudden Unexpected Infant Death : a Descriptive Study From the French Prospective Multisite Registry (OMIN)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sudden Unexpected Infant Death, Air Pollution, Pesticides
Keywords: Sudden unexpected infant death
Sudden infant death syndrome
Perinatal death
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: AXA Assurances VIE Mutuelle
name: ANSES
First posted: 2024-11-27
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The entire population concerns infants who died of MIN and are included in the OMIN registry. For the ambient air pollution axis, the inclusion criterion is the availability of geolocation (GPS) of the residence. For the pesticides axis, the inclusion criterion is the presence of biological samples in the 3 matrices of interest: serum, hair and cerebrospinal fluid.

Brief summary: This project is a descriptive study designed to identify the exposure of infants who died of MIN to ambient air pollutants, and to measure pesticide concentrations in biological matrices (hair, serum, LCS) within a sample from the OMIN registry. French national registry of STUDY of Sudden Unexpected Infant Death.

Detailed description: This project is a descriptive study designed to estimate the exposure of infants who died of MIN to ambient air pollutants, and to measure pesticide concentrations in biological matrices (hair, serum, LCS) within a sample from the OMIN registry. These two types of pollutants represent two important determinants of environmental health. Although their emission sources and chemical composition differ, these pollutants carry the risk of multiple toxicities that can contribute to the occurrence of Unexpected Infant Death Syndrome (SUID), and are widely present in France, in the air as well as in food, waterways, soils, etc. These two approaches have enabled us to develop two complementary methodologies: geostatistics associated with environmental epidemiology for air pollutants, and analytical environmental chemistry for pesticides.

In addition to matching these exposure measurements with data from the OMIN registry, we will be able to address the impact and determinants of these exposures - i.e., to highlight the individual and collective characteristics that favor high exposure, and to address the toxicological mechanisms linked to these exposures and that may contribute to the occurrence of SUID in general.

Eligibility criteria: Inclusion Criteria:

* Died and include in French registry of sudden infant death syndrome

Exclusion Criteria:

* None

Primary outcomes:
measure: Modeling cumulative exposure to several contaminants in ambient air, to ambient temperature in France and to pesticides through proximity to crops, and cross-referencing with data from the OMIN registry
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
References: