{"doc_desc":{"title":"Observatoire national des morts inattendues du nourrisson (OMIN)","idno":"FRESH-PEF74055-fr","producers":[{"name":"L\u00e9a FERRAND","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74055-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74055"},{"agency":"FReSH","code":"FRESH-PEF74055"}]},"title":"Observatoire national des morts inattendues du nourrisson (OMIN)","alternate_title":"Registre OMIN"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"L\u00e9a;FERRAND","PILabo":"CHU de Nantes \/ Centre d'Investigation Clinique - femme, Enfant, Adolescent","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"264400136","role":"organisation id"},{"title":"RNSR","uri":"200120109H","role":"labo 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theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"topic":"Syndrome de mort subite du nourrisson","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/56255971","title":"CIM-11"}]},{"topic":"D\u00e9terminants environnementaux : Climat","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"},{"topic":"Autre","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"Surveillance \u00e9pid\u00e9miologique Obtention de donn\u00e9es \u00e9pid\u00e9miologiques pr\u00e9cises et exhaustives Identification de nouveaux facteurs de risque des MIN D\u00e9veloppement de la recherche m\u00e9dicale dans le domaine des MIN","abstract":"","coll_dates":[{"start":"2020-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Nourrisson (28j \u00e0 2 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Enfant entre 0 et 24 mois D\u00e9c\u00e9d\u00e9 de mort inattendue du nourrisson  Pris en charge en France par un centre de r\u00e9f\u00e9rence de la MIN Parents ayant accept\u00e9 de participer \u00e0 l'observatoire\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Tests de coh\u00e9rence automatique et monitoring de 100% des dossiers']"}},"study_development":{"development_activity":[]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s libre","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"2236 au 20\/05\/2025"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Registre de morbidit\u00e9"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"La charte d'acc\u00e8s aux donn\u00e9es et aux \u00e9chantillons de l'OMIN est disponible sur le site https:\/\/www.chu-nantes.fr\/observatoire-national-de-la-mort-inattendue-du-nourrisson. Les demandes d'acc\u00e8s aux donn\u00e9es se font par l'interm\u00e9diaire d'une fiche projet qui doit \u00eatre envoy\u00e9e \u00e0 omin@chu-nantes.fr pour expertise par les membres du bureau restreint du conseil scientifique. L'avis est rendu sous 1 mois.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"----","lastUpdatedAuto":null,"lastUpdatedManual":"02-06-2025","isContributorPI":"Non","contributorName":"L\u00e9a FERRAND","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","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\/"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Priv\u00e9 \u00e0 but non lucratif","Priv\u00e9 \u00e0 but non lucratif","Industrie","Priv\u00e9 \u00e0 but non lucratif","Priv\u00e9 \u00e0 but non lucratif","Public (France)","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["","","","","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Non","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Cahier d'observation \u00e9lectronique","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"territoire fran\u00e7ais, DROM-COM compris"},"dataTypes":{"clinicalDataDetails":"lieu de d\u00e9c\u00e8s, ant\u00e9c\u00e9dents de l'enfant, \u00e9v\u00e9nements survenus dans les 72h pr\u00e9c\u00e9dants de d\u00e9c\u00e8s, examen clinique de l'enfant sur les lieux du d\u00e9c\u00e8s et au centre de r\u00e9f\u00e9rence, vaccination, traitement habituel,donn\u00e9es \u00e9pid\u00e9miologiques et socio environnementales","biologicalDataDetails":"biologie sanguine (leucocytes, taux d'h\u00e9moglobine, ur\u00e9mie, cr\u00e9atin\u00e9mie, calc\u00e9mie, CRP, PCT), ponction lombaire (prot\u00e9inorachie, glycorachie), toxicologie sanguine et urinaire, bilan m\u00e9tabolique, g\u00e9n\u00e9tique, analyse d'urine","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}