{"doc_desc":{"title":"Etude longitudinale fran\u00e7aise depuis l'enfance","idno":"FRESH-PEF3406-fr","producers":[{"name":"Marie-Aline CHARLES","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3406-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"3406"},{"agency":"FReSH","code":"FRESH-PEF3406"}]},"title":"Etude longitudinale fran\u00e7aise depuis l'enfance","alternate_title":"ELFE"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"name":"Thierry;SIMEON","firstname":"Thierry","lastname":"SIMEON","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02cnsac56","role":"organisation id"},{"title":"SIREN","uri":"198013443","role":"organisation id"}],"email":"thierry.simeon@ined.fr","affiliationName":"INSTITUT NATIONAL D'ETUDES DEMOGRAPHIQUES (INED)","PILabo":"INSTITUT NATIONAL D'ETUDES DEMOGRAPHIQUES (INED) \/ Ined, Inserm Elfe joint unit","isContact":true},{"name":"Marie-Aline;CHARLES","firstname":"Marie-Aline","lastname":"CHARLES","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"}],"email":"marie-aline.charles@inserm.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"Inserm \/ \u0093Elfe\u0094 INED-Inserm joint unit","isContact":true}],"oth_id":[{"name":"projet europ\u00e9ens Lifecycle, Longitools, PEPR Sant\u00e9 des femmes, Programme Impulsion Exposome de l'Inserm, Environment and Child International Study Group (ECHIG)","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","role":"sponsor id"}],"role":"sponsor"},{"name":"INSTITUT NATIONAL D'ETUDES DEMOGRAPHIQUES (INED)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02cnsac56","role":"sponsor id"},{"title":"SIREN","uri":"180037020","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE LA RECHERCHE (ANR)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rbzpz17"},{"title":"SIREN","uri":"130002504"}]},{"name":"MINISTERE DE L\u2019ENSEIGNEMENT SUPERIEUR, DE LA RECHERCHE ET DE L\u2019ESPACE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03sjk9a61"},{"title":"SIREN","uri":"110044013"}]}]},"distribution_statement":{"contact":[{"name":"Thierry;SIMEON","lastname":"SIMEON","firstname":"Thierry","type":"contact","email":"thierry.simeon@ined.fr","affiliationName":"INSTITUT NATIONAL D'ETUDES DEMOGRAPHIQUES (INED)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02cnsac56","role":"organisation id","title":"ROR"},{"uri":"198013443","role":"organisation id","title":"SIREN"}]},{"name":"Marie-Aline;CHARLES","lastname":"CHARLES","firstname":"Marie-Aline","type":"contact","email":"marie-aline.charles@inserm.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"socialisation"},{"keyword":"cadre de vie"},{"keyword":"grossesse"},{"keyword":"enfant"},{"keyword":"famille"},{"keyword":"croissance"},{"keyword":"d\u00e9veloppement"},{"keyword":"scolarit\u00e9"},{"keyword":"pollution"},{"keyword":"environnement"},{"keyword":"pubert\u00e9"}],"topics":[{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux : Addictions","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Climat","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques : Emploi","vocab":"health determinant"}],"purpose":"Etude des d\u00e9terminants du d\u00e9veloppement, de la sant\u00e9 et de la socialisation des enfants Elfe est l'une des deux cohortes constituantes de la plateforme RE-CO-NAI avec la cohorte Epipage 2. L'objectif g\u00e9n\u00e9ral de cette plateforme est de mettre en place une infrastructure offrant les dispositifs n\u00e9cessaires \u00e0 la collecte, au stockage hautement s\u00e9curis\u00e9 et \u00e0 la diffusion de donn\u00e9es sur la grossesse, la naissance et l'enfant. La plateforme de recherche ainsi constitu\u00e9e sur les cohortes d'enfants suivis depuis la naissance permettra d'\u00e9tudier de mani\u00e8re globale et multidisciplinaire les grands enjeux sur la sant\u00e9, le d\u00e9veloppement, et la socialisation des enfant. Elle donnera en outre une visibilit\u00e9 importante dans le monde de la recherche acad\u00e9mique (fran\u00e7aise et internationale), mais aussi aupr\u00e8s des instances , associations, industriels qui s'int\u00e9ressent \u00e0 l'enfance. Elle permettra ainsi une valorisation optimis\u00e9e des donn\u00e9es recueillies et facilitera la diss\u00e9mination des donn\u00e9es. Un recueil de donn\u00e9es clinique et biologique additionnel a \u00e9t\u00e9 r\u00e9alis\u00e9 lors du premier confinement pour la Covid19 dans le cadre du projet collaboratif entre cohortes Sapris","abstract":"","coll_dates":[{"start":"2011-01-01"}],"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            \"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    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" Les enfants n\u00e9s a partir de 33 semaines d\u2019am\u00e9norrh\u00e9e  - de grossesse unique ou g\u00e9mellaire - en France m\u00e9tropolitaine et sans projet de d\u00e9m\u00e9nagement hors de France dans les 3 ans suivant l'inclusion - m\u00e8re \u00e2ge de 18 ans et plus\",\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":"['CIM10']","committee":"","governance":""}],"other_quality_statement":"['Formation des enqu\u00eateurs, \u00e9coutes t\u00e9l\u00e9phoniques et accompagnement de visites \u00e0 domicile']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nConsommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Probability.Stratified\",\"vocab\":\"CESSDA\"},\"value\":\"Probabiliste : stratifi\u00e9\"}']","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\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}","{\"concept\":{\"vocabURI\":\"MeasurementsAndTests.Psychological\",\"vocab\":\"CESSDA\"},\"value\":\"Tests psychologiques\/\u00e9chelles cliniques (d\u00e9pression, cognition, qualit\u00e9 de vie...)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":["Base m\u00e9dico-administrative"]}],"target_sample_size":"[10000-20000[ individus","response_rate":"18,300"},"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":"Plateforme d'acc\u00e8s aux donn\u00e9es: acc\u00e8s via le site internet: www.elfe-france.fr\/acces-donnees ou acc\u00e8s direct: https:\/\/pandora.vjf.inserm.fr\/public\/","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Les propositions devront \u00eatre soumises \u00e0 un comit\u00e9 d'acc\u00e8s aux donn\u00e9es ELFE qui jugera de la pertinence du projet et de l'ad\u00e9quation des donn\u00e9es demand\u00e9es.","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":"12-04-2012","lastUpdatedAuto":null,"lastUpdatedManual":"02-06-2025","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"List of publications in HAL","link":"http:\/\/tinyurl.com\/HAL-ELFE"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)","Public (France)"],"otherSponsorType":["",""]},"governance":{"committee":true},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"- Auto-questionnaire alimentation et exposition pendant la grossesse rempli par la m\u00e8re en maternit\u00e9.- relev\u00e9 du dossier obst\u00e9trical- Entretien face \u00e0 face, \u00e0 domicile- Enqu\u00eates t\u00e9l\u00e9phoniques- Auto-questionnaires alimentation de l'enfant entre 3 et 10 mois.- Examen par le m\u00e9decin traitant lors de la visite 24 Mois et \u00e0 12 ANS.- Examen PMI en \u00e9cole maternelle - Examn par enqu\u00eateur \u00e0 10 ans (tests cognitifs, anthropom\u00e9trie..) - appariement avec le SNDS, bases de donn\u00e9es de surveillance environnementales- recueil d'information aupr\u00e8s des enseignants","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":true},"geographicalCoverage":{"geoDetail":"France m\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"> Donn\u00e9es disponibles dans les dossiers m\u00e9dicaux au moment de la naissance: caract\u00e9ristiques de l'enfant nouveau-n\u00e9 (poids, taille, \u00e2ge gestationnel, les anomalies cong\u00e9nitales, les circonstances de l'accouchement, infections ...) > Examens m\u00e9dicaux: la vaccination, l'ou\u00efe, la vision, poids \/ taille\/ tour de taille, pression art\u00e9rielle l'asthme, les allergies, organes g\u00e9nitaux et les tests neuro-psycho-moteur \u00e0 diff\u00e9rents \u00e2ges","biologicalDataDetails":"A l'accouchement urine, sang veineux et cheveux de la m\u00e8re en suites de couches: Lait maternel , meconium, selles (\u00e0 J3); Urines, cheveux selles de l'enfant \u00e0 3,5 ans; Urine, cheveux, sang, salive \u00e0 10 ans","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"isHealthTheme":false,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}