Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT06708793
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-03
First Post:
2024-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Environmental Exposures and Sudden Unexpected Infant Death
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013398', 'term': 'Sudden Infant Death'}, {'id': 'D066087', 'term': 'Perinatal Death'}], 'ancestors': [{'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D066088', 'term': 'Infant Death'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-28', 'studyFirstSubmitDate': '2024-11-26', 'studyFirstSubmitQcDate': '2024-11-26', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sudden unexpected infant death', 'Sudden infant death syndrome', 'Perinatal death'], 'conditions': ['Sudden Unexpected Infant Death, Air Pollution, Pesticides']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Minute', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Died and include in French registry of sudden infant death syndrome\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT06708793', 'acronym': 'ExpoMIN', 'briefTitle': 'Environmental Exposures and Sudden Unexpected Infant Death', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Environmental Exposures and Sudden Unexpected Infant Death : a Descriptive Study From the French Prospective Multisite Registry (OMIN)', 'orgStudyIdInfo': {'id': 'RC23_0513'}}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'AXA Assurances VIE Mutuelle', 'class': 'UNKNOWN'}, {'name': 'ANSES', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}