{"doc_desc":{"title":"Cohorte m\u00e8res-enfants \/ \u00e9valuation des cons\u00e9quences des expositions professionnelles ou environnementales \u00e0 des polluants chimiques sur la sant\u00e9 de l'enfant","idno":"FRESH-PEF73143-fr","producers":[{"name":"C\u00e9cile CHEVRIER","affiliation":"UNIVERSITE DE RENNES"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73143-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73143"},{"agency":"FReSH","code":"FRESH-PEF73143"}]},"title":"Cohorte m\u00e8res-enfants \/ \u00e9valuation des cons\u00e9quences des expositions professionnelles ou environnementales \u00e0 des polluants chimiques sur la sant\u00e9 de l'enfant","alternate_title":"PELAGIE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"C\u00e9cile;CHEVRIER","PILabo":"IRSET U1085 INSERM Universit\u00e9 Rennes 1","affiliationName":"UNIVERSITE DE RENNES","extlink":[{"title":"ORCID","uri":"0000-0003-3101-8222","role":"pi 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(ANSES)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0471kz689"},{"title":"SIREN","uri":"130012024"}]},{"name":"ARS BRETAGNE","extlink":[{"title":"SIREN","uri":"130007966"}]},{"name":"FONDATION DE FRANCE","extlink":[{"title":"SIREN","uri":"784314908"}]},{"name":"MINISTERE DU TRAVAIL ET DES SOLIDARITES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/018k53h31"},{"title":"SIREN","uri":"110000072"}]},{"name":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58"},{"title":"SIREN","uri":"130022338"}]}]},"distribution_statement":{"contact":[{"name":"C\u00e9cile;CHEVRIER","email":"cecile.chevrier@inserm.fr","type":"contact","affiliationName":"UNIVERSITE DE RENNES","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/015m7wh34","role":"organisation id","title":"ROR"},{"uri":"130030513","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"d\u00e9veloppement de l'enfant"},{"keyword":"Th\u00e8mes principaux de la cohorte : Sant\u00e9 et environnement"},{"keyword":"solvants"},{"keyword":"polluants organiques persistants"},{"keyword":"Pesticides"}],"topics":[{"topic":"Endocrinologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D004704"}]},{"topic":"Gyn\u00e9cologie et obst\u00e9trique","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7de64596-5b0d-4977-8f98-b982ff2ec17d"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/284ca20c-beb4-4abe-99fa-ef4513358bad"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D006176"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009774"}]},{"topic":"P\u00e9diatrie","vocab":"health 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":"N\u00e9phrologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3961e9d2-ab3b-451b-b246-20fc0ec3b0c4"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009398"}]},{"topic":"D\u00e9terminants environnementaux : Climat","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":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques : Emploi","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : \u00e9valuer les cons\u00e9quences des expositions professionnelles ou environnementales pendant la grossesse, en particulier solvants, pesticides, polluants persistants et d\u00e9riv\u00e9s de la chloration de l'eau sur le d\u00e9roulement de la grossesse et le d\u00e9veloppement de l'enfant. Objectifs secondaires : - identifier les sources environnementales et les d\u00e9terminants individuels (caract\u00e9ristiques sociod\u00e9mographiques, habitudes de vie, susceptibilit\u00e9 g\u00e9n\u00e9tique) des expositions aux polluants mesur\u00e9es par des biomarqueurs ; - \u00e9tudier les r\u00f4les respectifs des expositions pr\u00e9natales et dans l'enfance ;","abstract":"","coll_dates":[{"start":"2002-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Bretagne']","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\": \"Petite enfance (2 \u00e0 5 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Femmes au cours de leur premier trimestre de grossesse (inf\u00e9rieur \u00e0 19 semaines d'am\u00e9norrh\u00e9e) r\u00e9sidant dans l'un des d\u00e9partements participant \u00e0 l'\u00e9tude.\",\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']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques.Gestion des donn\u00e9es manquantes par retour vers un tiers.Relance des sujets pour r\u00e9aliser les visites de suivi.Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9"}]},"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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"3421"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"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":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques. Utilisation possible des donn\u00e9es par des industriels \u00e0 d\u00e9terminer.","conditions":"","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":"09-07-2015","lastUpdatedAuto":null,"lastUpdatedManual":"05-07-2023","isContributorPI":"Non","contributorName":"C\u00e9cile CHEVRIER","contributorAffiliation":"UNIVERSITE DE RENNES","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"List of publications in HAL","link":"http:\/\/www.hal.inserm.fr\/PELAGIE"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Public (France)","Priv\u00e9 \u00e0 but non lucratif","Public (France)","Public (France)"],"otherFundingAgentType":["","","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Auto-questionnaire : saisie manuelle avec double saisie Examens cliniques : saisie manuelle avec double saisie","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Cohorte multicentrique (40 centres) fran\u00e7aise: ILLE ET VILAINE, COTES D'ARMOR, FINISTERE"},"dataTypes":{"clinicalDataDetails":"Examen clinique au cours du suivi \u00e0 l'accouchement, \u00e0 6 ans (d\u00e9veloppement neurospychologique), \u00e0 12 ans (examen de la croissance, et du d\u00e9veloppement pubertaire), \u00e0 18-20 ans (sant\u00e9 cardiom\u00e9tabolique, reproductive, respiratoire, dentaire...)","biologicalDataDetails":"Type de pr\u00e9l\u00e8vements r\u00e9alis\u00e9s : sang du cordon ombilical, urines des m\u00e8res (pr\u00e9natales) et enfants, fragment de placenta, cheveux des m\u00e8res (naissance) et des enfants, salive (m\u00e8res, enfants), sang (enfants)","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}