{"doc_desc":{"title":"National Observatory of Unexpected Infant Deaths","idno":"FRESH-PEF74055-en","producers":[{"name":"L\u00e9a Ferrand","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74055-en","IDno":{"metadata_no":[{"agency":"PEF","code":"74055"},{"agency":"FReSH","code":"FRESH-PEF74055"}],"metadata_yes":[{"code":"FReSH","agency":"FReSH"}]},"title":"National Observatory of Unexpected Infant Deaths","alternate_title":"Registre OMIN"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Christ\u00e8le;GRAS LE GUEN","firstname":"Christ\u00e8le","lastname":"GRAS LE GUEN","type":"investigator","extlink":[{"title":"ORCID","uri":"","role":"pi id"},{"title":"IdRef","uri":"","role":"pi id"},{"title":"ROR","uri":"https:\/\/ror.org\/05c1qsg97","role":"organisation id"},{"title":"SIREN","uri":"264400136","role":"organisation id"},{"title":"RNSR","uri":"","role":"labo id"}],"email":"christele.grasleguen@chu-nantes.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","PILabo":"CHU de Nantes \/ Centre d'Investigation Clinique - femme, Enfant, Adolescent","isContact":false}],"oth_id":[{"name":";","firstname":"","lastname":"","type":"contributor","isContact":"","extlink":[{"title":"ORCID","uri":"","role":"team member id"},{"title":"IdRef","uri":"","role":"team member id"}]},{"name":"","type":"affiliation","teamMemberLabo":"","extlink":[{"title":"RNSR","uri":"","role":"labo id"}]},{"name":"Soci\u00e9t\u00e9 Fran\u00e7aise pour l'Etude et la Pr\u00e9vention de la Mort Inattendue du Nourrisson et de l'Enfant (SFMINE)","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","role":"sponsor","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05c1qsg97","role":"sponsor id"},{"title":"SIREN","uri":"264400136","role":"sponsor id"}]}],"funding_agencies":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05c1qsg97"},{"title":"SIREN","uri":"264400136"}]},{"name":"FONDATION AXA"},{"name":"LES RIRES D'ANNA","extlink":[{"title":"SIREN","uri":"924663008"}]},{"name":"NAITRE ET VIVRE","extlink":[{"title":"SIREN","uri":"391377975"}]},{"name":"SA VIE"},{"name":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58"},{"title":"SIREN","uri":"130022338"}]}]},"distribution_statement":{"contact":[{"name":"L\u00e9a;FERRAND","lastname":"FERRAND","firstname":"L\u00e9a","type":"contact","email":"lea.ferrand@chu-nantes.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","contactPointLabo":"University of Nantes, Nantes University Hospital, INSERM, UIC Women, Children, and Adolescents, CIC 1413, Nantes, France","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05c1qsg97","role":"organisation id"},{"title":"SIREN","uri":"264400136","role":"organisation id"},{"title":"RNSR","uri":"","role":"labo id"}]}]},"study_info":{"keywords":[{"keyword":"Unexpected infant death"},{"keyword":"Sudden infant death syndrome"},{"keyword":"National registry"}],"topics":[{"topic":"Paediatrics","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"D010372"}],"vocab":"health theme"},{"topic":"Public, environmental and occupational health","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/b533acc2-aff1-4c65-80ca-5d5bee865ba9"},{"title":"MeSH","uri":"D004778"}],"vocab":"health theme"},{"topic":"Sudden infant death syndrome","vocab":"cim-11","extLink":[{"title":"CIM-11","uri":"http:\/\/id.who.int\/icd\/entity\/56255971"}]},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Employment","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Education level","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Age","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"},{"topic":"Environmental determinants: Climate","vocab":"health determinant"},{"topic":"Environmental determinants: Other","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Behavioral determinants: Eating habits","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Biological determinants: Sex","vocab":"health determinant"},{"topic":"Other","vocab":"health determinant"}],"purpose":"Epidemiological surveillance Obtain accurate and comprehensive epidemiological data Identification of new risk factors for SIDS Development of medical research in the field of SIDS","abstract":"Sudden infant death (SIDS) is defined as \u201ca sudden death in a child under 1 year of age that could not have been predicted by in the child\u2019s known medical history could have predicted it,\u201d whereas \u201csudden infant death (SID)\u201d is the death of an infant under 1 year of age that cannot be explained by the clinical history or by postmortem investigations; in France, the Haute Autorit\u00e9 de Sant\u00e9 (HAS) has set the upper age limit at 2 years.  In 2007, the HAS published recommendations for the management of SIDS intended for the 30 \u201cSIDS\u201d reference centers; it described  the diagnostic procedures to be implemented, which, following an investigation by the French Institute for Public Health Surveillance in 2009, were found to be followed very inconsistently. Since then, no further data has been published in France, and this condition has been the subject of very little research, even though it still affects 300 to 400 infants per year, 50 to 70% of whom remain unexplained deaths.  It is thus the leading cause of death among infants aged 1 month to 1 year in France.\r\nThe objective of this project is to establish a French National Observatory on Minor Injuries (OMIN) with three main goals: 1) to obtain accurate epidemiological data on this condition, 2) to identify its determinants, and 3) to describe its management in French referral centers. In the medium term, these figures will enable the development of clear and up-to-date prevention messages for the general public and healthcare professionals. Based on these figures, hypotheses for clinical and basic research can also be formulated and serve as the rationale for studies drawing on the diversity of data collected through the registry.\r\nThis registry includes all children under the age of 2 admitted for MIN at French referral centers. A wide range of clinical, biological, radiological, and pathological data is collected in an online observation log. Biological samples for a biobank are also collected following signed parental consent. All of this data will be analyzed under the responsibility of the OMIN Scientific Committee to ensure the best possible scientific use of the information. Environmental conditions at the time of death are systematically reported (sleeping position, bedding, smoking, etc.). Access to these patients\u2019 DNA will also enable genetic research to test the potential predisposing role of certain genes. The consequences of pre- or postnatal exposure to certain nutrients or chemical, biological, or pharmaceutical toxins can be precisely characterized by cross-referencing data recorded by the observatory with that of the National Health Data System (SNDS).\r\nWhether in France or internationally, there is an urgent need to collect epidemiological, clinical, environmental, biological, and health-related data on NCDs. We are proposing here an original and unique project in this field. This registry, and the analysis of the data it contains, constitutes an essential starting point for the development and evaluation of future, more effective information and prevention campaigns in the field of NCDs. By simultaneously providing a wide variety of research data, this registry will also facilitate cutting-edge scientific research based on evidence-based hypotheses, leading to the discovery of original findings in the field of NCDs.","coll_dates":[{"start":"2016-02-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Auvergne Rh\u00f4ne-Alpes','Bourgogne Franche-Comt\u00e9','Bretagne','Centre-Val de Loire','Grand Est','Guadeloupe','Guyane','Hauts-de-France','Ile-de-France','La R\u00e9union','Martinique','Normandie','Nouvelle-Aquitaine','Occitanie','Pays de la Loire','Provence - Alpes - C\u00f4te d'Azur']","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D005260\"\n            },\n            \"value\": \"Female\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D008297\"\n            },\n            \"value\": \"Male\"\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D007231\"\n            },\n            \"value\": \"Infant, Newborn (birth to 28 days)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D007223\"\n            },\n            \"value\": \"Infant (28 days to 2 years)\"\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Infant aged 0 to 24 months who died of sudden infant death syndrome and was treated in France by a MIN reference center\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Biological data','Socio-demographic data','Environmental \/ exposure data','Economic data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Automatic consistency checks and monitoring of 100% of files']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Cause of death"},{"activity_type":"secondary evaluation","activity_description":""}]},"method":{"data_collection":{"time_method":"Prospective longitudinal","frequency":"Daily","sampling_procedure":"['{\"concept\":{\"vocab\":\"CESSDA\",\"vocabURI\":\"TotalUniverseCompleteEnumeration\"},\"value\":\"Complete enumeration (including consecutive recruitment)\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocab\":\"CESSDA\",\"vocabURI\":\"Transcription\"},\"value\":\"Converting or copying information into a structured record\"}","{\"concept\":{\"vocab\":\"CESSDA\",\"vocabURI\":\"Interview\"},\"value\":\"Interview with the participant (including clinical)\"}","{\"concept\":{\"vocab\":\"CESSDA\",\"vocabURI\":\"Observation\"},\"value\":\"Observation (clinical or behavioural)\"}"],"research_instrument":"Free admission","sources":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":[]}],"target_sample_size":"[1000-10000[ individuals","response_rate":"2441 au 05\/05\/2026"},"method_notes":"Observational Study","study_class":"Ongoing study","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Morbidity registry"]}]},"data_access":{"dataset_availability":{"access_place":"Nantes University Hospital","complete":"","status":"{\"extLink\":{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"},\"value\":\"Restricted access\"}"},"dataset_use":{"restrictions":"","conditions":"The OMIN data and sample access charter is available on request from bp-coordination-omin@chu-nantes.fr Requests for access to data are made by means of a project form, which must be sent to omin@chu-nantes.fr for appraisal by members of the Scientific Advisory Board. The opinion is given within 1 month.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"https:\/\/www.omin.fr\/charte-dutilisation-des-donnees-processus-demande\/","required":"Yes"}],"contact":[{"name":"L\u00e9a;FERRAND","firstname":"L\u00e9a","lastname":"FERRAND","email":"lea.ferrand@chu-nantes.fr"}],"deposit_req":"Yes","cit_req":"OMIN Study Group and CRB, if applicable"},"notes":""}},"additional":{"IsImport":false,"versionLang":"en","originLang":"en","lastUpdatedAuto":"29-05-2026","lastUpdatedManual":"29-05-2026","autoTranslation":false,"status":"Awaiting validation","respValidation":"","isHealthTheme":true,"isContributorPI":false,"addTeamMember":false,"primaryInvestigator":{"isPIContact":false,"piMail":"christele.grasleguen@chu-nantes.fr","piAffiliation":{"piLabo":"CHU de Nantes \/ Centre d'Investigation Clinique - femme, Enfant, Adolescent"}},"relatedDocument":[{"type":"Publication defining the database and\/or its collection protocol  (data paper, cohort profile, method\/protocol paper, resource paper, data note, registered report...)","title":"Desription du fonctionnement et des don\u00e9nes du registre sur les 7 premi\u00e8res ann\u00e9es de fonctionnement","link":"https:\/\/pubmed.ncbi.nlm.nih.gov\/39313586\/"}],"contactPointLabo":"University of Nantes, Nantes University Hospital, INSERM, UIC Women, Children, and Adolescents, CIC 1413, Nantes, France","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Private non-profit","Private non-profit","Private non-profit","Private non-profit","Public (France)"],"otherFundingAgentType":["","","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":false},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":false,"allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[{"name":"Sudden Infant Death","type":"Public Health","typeOther":""}],"cohortLongitudinal":{"recrutementTiming":[]},"otherResearchType":{"otherResearchTypeDetails":""},"inclusionGroups":[],"nrInclusionGroups":false,"collectionProcess":{"collectionModeDetails":"Electronic observation log","collectionModeOther":""},"dataCollection":{"inclusionStrategy":[],"samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"French territory, including overseas departments and territories"},"dataTypes":{"clinicalDataDetails":"place of death, the child\u2019s medical history, events occurring within 72 hours prior to death, clinical examination of the child at the scene of death and at the referral center, vaccinations, usual treatment, epidemiological and socio-environmental data","biologicalDataDetails":"Blood biology (leukocytes, hemoglobin, uremia, creatinemia, serum calcium, CRP, PCT), lumbar puncture (proteinorachia, glycorachia), blood and urinary toxicology, metabolic balance, genetics, urine analysis","isDataInBiobank":true,"biobankContent":["Nucleic acids","Whole blood","Plasma","Serum","Other fluids and secretions"],"biobankContentOther":"","dataTypeOther":"","paraclinicalDataOther":"","otherLiquidsDetails":"stool, hair, nasopharyngeal secretions, cerebrospinal fluid"},"variableDictionnary":{"variableDictionnaryAvailable":true,"variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":false,"mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}