{"doc_desc":{"title":"Etude transversale sur l'\u00e9valuation des fonctions cognitives des enfants ayant un d\u00e9ficit en hormone de croissance et des enfants n\u00e9s petits pour l'\u00e2ge gestationnel","idno":"FRESH-PEF100-fr","producers":[{"name":"Sylvie TROY","affiliation":"PFIZER (FRANCE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF100-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"100"},{"agency":"FReSH","code":"FRESH-PEF100"}]},"title":"Etude transversale sur l'\u00e9valuation des fonctions cognitives des enfants ayant un d\u00e9ficit en hormone de croissance et des enfants n\u00e9s petits pour l'\u00e2ge gestationnel","alternate_title":"m\u00e9MOTS"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Sylvie;TROY","PILabo":"Pfizer","affiliationName":"PFIZER (FRANCE)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"433623550","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"sylvie.troy@pfizer.com","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"PFIZER (FRANCE)","role":"sponsor","extlink":{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10","role":"sponsor id"}}],"funding_agencies":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10"}}]},"distribution_statement":{"contact":[{"name":"Sylvie;TROY","email":"sylvie.troy@pfizer.com","type":"contact","affiliationName":"PFIZER (FRANCE)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02c9yny10","role":"organisation id","title":"ROR"},{"uri":"433623550","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"fonctions cognitives enfant"},{"keyword":"hormone de croissance"}],"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":"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":"D\u00e9ficit en hormone de croissance","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1317547930","title":"CIM-11"}]},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"- Evaluer le niveau des fonctions cognitives verbales et non verbales des enfants avec un d\u00e9ficit en hormone de croissance (GHD) et des enfants n\u00e9s petits pour l\u2019\u00e2ge gestationnel (SGA) avant d\u00e9but du traitement par GH. - Evaluer le pourcentage d\u2019enfants GHD et le pourcentage d\u2019enfants SGA avec des troubles des fonctions cognitives langagi\u00e8res. - Evaluer le pourcentage d\u2019enfants GHD et le pourcentage d\u2019enfants SGA avec des troubles des fonctions cognitives non verbales. - Comparer le niveau moyen des fonctions cognitives langagi\u00e8res et non langagi\u00e8res des enfants GHD et SGA \u00e0 une population de r\u00e9f\u00e9rence d\u2019enfants fran\u00e7ais. - Comparer le niveau des fonctions cognitives verbales et non verbales des enfants GHD et des enfants SGA.","abstract":"","coll_dates":[{"start":"2007-01-01","end":"2010-01-01"}],"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\": \"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    \"level_type_clusion_I\": [\n        \"Patients\"\n    ],\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" Enfant \u00e2g\u00e9 de 4 \u00e0 9 ans, - Comprenant le fran\u00e7ais, - Dont le traitement par GH a \u00e9t\u00e9 approuv\u00e9 par une caisse d\u2019assurance maladie, - Avec une suppl\u00e9mentation ad\u00e9quate des autres d\u00e9ficits hypophysaires en cas de d\u00e9ficit multiple.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Qualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"Etude transversale non r\u00e9p\u00e9t\u00e9e","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 restreint sur projet sp\u00e9cifique","sources":[[]],"target_sample_size":"< 500 individus","response_rate":"-33-"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"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":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"creationDate":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2020","isContributorPI":"Non","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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":"CRF papier","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France m\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}