{"doc_desc":{"title":"Cohorte Paris : \u00e9tude des environnements int\u00e9rieur et ext\u00e9rieur des enfants","idno":"FRESH-PEF6942-fr","producers":[{"name":"Isabelle MOMAS","affiliation":"UNIVERSITE PARIS CITE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF6942-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"6942"},{"agency":"FReSH","code":"FRESH-PEF6942"}]},"title":"Cohorte Paris : \u00e9tude des environnements int\u00e9rieur et ext\u00e9rieur des enfants","alternate_title":"PARIS"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Isabelle;MOMAS","PILabo":"MAIRIE DE \/ EA 4064 UNIVERSITE PARIS DESCARTES ET MAIRIE DE PARIS CELLULE \u00ab COHORTE \u00bb","affiliationName":"UNIVERSITE PARIS CITE","extlink":[{"title":"ORCID","uri":"0000-0003-4344-3787","role":"pi id"},{"title":"IdRef","uri":"059579331","role":"pi id"},{"title":"SIREN","uri":"130025737","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"isabelle.momas@u-paris.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"VILLE DE PARIS","extlink":[{"title":"SIREN","uri":"217500016","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE SECURITE SANITAIRE DE L ALIMENTATION DE L ENVIRONNEMENT ET DU TRAVAIL (ANSES)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0471kz689"},{"title":"SIREN","uri":"130012024"}]},{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14"},{"title":"SIREN","uri":"267500452"}]},{"name":"CAISSE PRIMAIRE ASSURANCE MALADIE PARIS (CPAMP)","extlink":[{"title":"SIREN","uri":"323841353"}]},{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]},{"name":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58"},{"title":"SIREN","uri":"130022338"}]},{"name":"VILLE DE PARIS","extlink":[{"title":"SIREN","uri":"217500016"}]}]},"distribution_statement":{"contact":[{"name":"Isabelle;MOMAS","email":"isabelle.momas@u-paris.fr","type":"contact","affiliationName":"UNIVERSITE PARIS CITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05f82e368","role":"organisation id","title":"ROR"},{"uri":"130025737","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"circonstances d\u2019apparition"},{"keyword":"signes cliniques \u00e9vocateurs"},{"keyword":"param\u00e8tres anthropom\u00e9triques"},{"keyword":"statut atopique"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"survenue"},{"keyword":"caract\u00e9ristiques"},{"keyword":"fr\u00e9quence"},{"keyword":"vaccinations"}],"topics":[{"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":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : \u00c9tudier les relations entre d\u2019une part, la sant\u00e9 respiratoire, les allergies au cours des premiers mois et des premi\u00e8res ann\u00e9es de vie et, d\u2019autre part, le mode et le cadre de vie des jeunes enfants, notamment les caract\u00e9ristiques des environnements int\u00e9rieur et ext\u00e9rieur dans lesquels ils \u00e9voluent Objectifs secondaires : - \u00c9tudier l\u2019incidence de la symptomatologie respiratoire et allergique chez des nourrissons franciliens, puis de l\u2019asthme, de la rhinite allergique et de la dermatite atopique chez ces jeunes enfants - Constituer un v\u00e9ritable observatoire de l\u2019histoire des premi\u00e8res ann\u00e9es de vie de jeunes parisiens, en documentant aussi bien l\u2019\u00e9volution de leur \u00e9tat de sant\u00e9 que celle de leur cadre et de leur mode de vie.","abstract":"","coll_dates":[{"start":"2003-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Ile-de-France']","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\": \"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\": \"M\u00e9dicaux : - grossesse non multiple ; - naissance \u00e0 terme, entre 37 et 42 semaines d\u2019am\u00e9norrh\u00e9e ; - poids \u00e0 la naissance compris entre le 10e et le 90e percentile, d\u2019apr\u00e8s les courbes de croissance de mamelle  repr\u00e9sentant le poids en fonction de la dur\u00e9e de gestation, chez les gar\u00e7ons et chez les filles ; - pas d\u2019intubation \u00e0 la naissance, ni de r\u00e9animation sp\u00e9cialis\u00e9e ; - score d\u2019Apgar \u00e9gal \u00e0 10\\\/10 \u00e0 la 5e minute ; - pas de malformation connue, ni de pathologie chronique impliquant un traitement au long cours, d\u00e8s la p\u00e9riode n\u00e9onatale pr\u00e9coce (toxoplasmose, virus de l\u2019immunod\u00e9ficience humaine, ...) ; - pas de pathologie respiratoire n\u00e9cessitant une surveillance m\u00e9dicale particuli\u00e8re, attest\u00e9e par le p\u00e9diatre lors de l\u2019examen clinique de sortie du service de suite de couches. Socio-demographiques : - lieu de r\u00e9sidence \u00e0 Paris ou en petite couronne (75, 92, 93, 94) ; - maitrise du fran\u00e7ais par la m\u00e8re de l\u2019enfant ; - pas de projet de d\u00e9m\u00e9nagement en dehors de la zone d\u2019\u00e9tude dans les 2 ann\u00e9es \u00e0 venir\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence au moment de la saisie des donn\u00e9es informatiques et apr\u00e8s la saisie des donn\u00e9es informatiques Gestion des donn\u00e9es manquantes par retour au dossier source ou retour vers le patient 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\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"3839"},"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 : \u00e0 d\u00e9terminer Utilisation non possible des donn\u00e9es par des industriels","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":"09-07-2013","lastUpdatedAuto":null,"lastUpdatedManual":"01-08-2014","isContributorPI":"Non","contributorName":"Isabelle MOMAS","contributorAffiliation":"UNIVERSITE PARIS CITE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/tinyurl.com\/HAL-PARIS"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Public (France)","Public (France)","Public (France)","Public (France)"],"otherFundingAgentType":["","","","","",""]},"sponsor":{"sponsorType":["Industrie"],"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":"Autoquestionnaire : Saisie \u00e0 partir d\u2019un questionnaire papier (Saisie manuelle) avec double saisie Entretiens : Saisie \u00e0 partir d\u2019un questionnaire papier (Saisie manuelle) avec double saisie Examens cliniques : Etape manuscrite (Saisie manuelle) avec double saisie Examens biologiques : Etape manuscrite (Saisie manuelle) avec double saisie","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Paris et petit couronne"},"dataTypes":{"clinicalDataDetails":"Examen clinique au cours du suivi Informations recueillies lors de l'examen clinique : - param\u00e8tres anthropom\u00e9triques ;- donn\u00e9es de l\u2019interrogatoire ;- donn\u00e9es de l\u2019examen clinique \u00e0 18 mois et \u00e0 7 ans ;- performances ventilatoires appr\u00e9ci\u00e9es par les EFR \u00e0 7 ans et mesure du monoxyde d\u2019azote dans l\u2019air expir\u00e9 (marqueur de l\u2019inflammation bronchique) ;- d\u00e9termination du statut atopique (IGE totales et sp\u00e9cifiques de diff\u00e9rents allerg\u00e8nes \u00e0 18 mois et \u00e0 7 ans ; r\u00e9sultats des tests cutan\u00e9s allergologiques \u00e0 7 ans).","biologicalDataDetails":"Type de pr\u00e9l\u00e8vements r\u00e9alis\u00e9s : Sanguins et d'urines","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}