{"doc_desc":{"title":"Etude EPId\u00e9miologique sur les Petits \u00c2ges GEstationnels","idno":"FRESH-PEF3438-fr","producers":[{"name":"Pierre-Yves ANCEL","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3438-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"3438"},{"agency":"FReSH","code":"FRESH-PEF3438"}]},"title":"Etude EPId\u00e9miologique sur les Petits \u00c2ges GEstationnels","alternate_title":"EPIPAGE"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CESREES"}]},"authoring_entity":[{"name":"Pierre-Yves;ANCEL","firstname":"Pierre-Yves","lastname":"ANCEL","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"}],"email":"pierre-yves.ancel@inserm.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE - \/ U953 - Unit\u00e9 de recherche \u00e9pid\u00e9miologique en sant\u00e9 p\u00e9rinatale et sant\u00e9 des femmes et des enfants","isContact":true},{"name":"B\u00e9atrice;LARROQUE","firstname":"B\u00e9atrice","lastname":"LARROQUE","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"}],"email":"","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE - \/ U953 - Unit\u00e9 de recherche \u00e9pid\u00e9miologique en sant\u00e9 p\u00e9rinatale et sant\u00e9 des femmes et des enfants","isContact":false}],"oth_id":[{"name":""}],"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"}],"funding_agencies":[{"name":"FONDATION POUR LA RECHERCHE MEDICALE","extlink":[{"title":"SIREN","uri":"784314064"}]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"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":"MSD FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00kt5kp12"},{"title":"SIREN","uri":"417890589"}]},{"name":"PFIZER (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10"},{"title":"SIREN","uri":"433623550"}]}]},"distribution_statement":{"contact":[{"name":"Pierre-Yves;ANCEL","lastname":"ANCEL","firstname":"Pierre-Yves","type":"contact","email":"pierre-yves.ancel@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":"comportement"},{"keyword":"capacit\u00e9s cognitives"},{"keyword":"scolarit\u00e9"},{"keyword":"recours au soin"},{"keyword":"morbidit\u00e9"},{"keyword":"mortalit\u00e9"}],"topics":[{"topic":"Neurologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009462"}]},{"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"}]}],"purpose":"Etudier le devenir des enfants grands pr\u00e9matur\u00e9s n\u00e9s entre 22 et 32 semaines d'\u00e2ge gestationnel dans 9 r\u00e9gions de France en 1997, et deux groupes de comparaison \u00e0 33-34 et 39-40 semianes.","abstract":"","coll_dates":[{"start":"1997-01-01","end":"2008-01-01"}],"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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Enfants grands pr\u00e9matur\u00e9s (naissances ou interruptions 22-32 semaines d'amh\u00e9nor\u00e9e (SA) ou 0,5 - 1,499kg. T\u00e9moins: groupes 1 : 39-40 SA et groupe2 : 33-34 SA  dans les centres participant \u00e0 l'\u00e9tude\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"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 les professionnels d'exercice lib\u00e9ral 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":[],"target_sample_size":"[1000-10000[ individus","response_rate":"3219 sujets avec suivi accept\u00e9 \u00e0 la p\u00e9riode n\u00e9onatale: 2276 grands pr\u00e9matur\u00e9s, 382 n\u00e9s \u00e0 33- 34 semaines d'\u00e2ge gestationel, 555 n\u00e9s \u00e0 39-40 semaines d'\u00e2ge gestationel"},"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":"","conditions":"Contacter le responsable scientifique","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":"16-04-2012","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2018","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/www.hal.inserm.fr\/EPIPAGE"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif","Public (France)","Public (France)","Industrie","Industrie"],"otherFundingAgentType":["","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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":"A l'inclusion: Les donn\u00e9es issues des dossier de maternit\u00e9 (surveillance grossesse, pathologies d\u00e9pist\u00e9es, traitement mis en oeuvre, d\u00e9roulement de l'accouchement, \u00e9tat de l'enfant \u00e0 la naissance, conditions de prise en charge) ou de n\u00e9onatologie (pathologie survenue en cours d'hospitaalisation, complications, traitement mis en oeuvre, \u00e9tat de l'enfant \u00e0 la sortie)Des donn\u00e9es sociod\u00e9mographiques sont recueillies au moment d'un interview.Au cours du suivi:A 2 ans, un examen m\u00e9dical de l'enfant orient\u00e9 motricit\u00e9 est r\u00e9alis\u00e9 par le m\u00e9decin traitant. Les parents sont \u00e9galement interrog\u00e9s.A 5 ans: le poids, la taille, le p\u00e9rim\u00e8tre cranien sont mesur\u00e9s et un examen neurologique et des test des fonctions cognitives (KABC) sont r\u00e9alis\u00e9s par une psychologue.Un autoquestionnaire est envoy\u00e9 aux parents \u00e0 9 mois, 1 an; 2,3,4,5 ans et 8 ans. Ce questionnaire est adapt\u00e9 \u00e0 l'\u00e2ge de l'enfant et concerne sa prise en charge, sa sant\u00e9 et son d\u00e9veloppement, son d\u00e9veloppement psychomoteur, et recueille des donn\u00e9es sociod\u00e9mographiques.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"9 r\u00e9gions de France: Alsace, Franche-Comt\u00e9, Languedoc - Roussillon, Lorraine, Midi-Pyr\u00e9n\u00e9es, Nord Pas-de-Calais, Haute Normandie, Pays de Loir et Paris et Petite couronne"},"dataTypes":{"clinicalDataDetails":"--","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}