{"doc_desc":{"title":"Physical and neurological becoming of highly premature children in the Aquitaine region","idno":"FRESH-PEF3582-en","producers":[{"name":"Val\u00e9rie GARCIA","affiliation":"UNIVERSITE DE BORDEAUX"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3582-en","IDno":{"metadata_no":[{"agency":"PEF","code":"3582"},{"agency":"FReSH","code":"FRESH-PEF3582"}]},"title":"Physical and neurological becoming of highly premature children in the Aquitaine region","alternate_title":"AQUIPAGE"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Laurence;JOLY-PEDESPAN","PILabo":"ISPED- Institut de Sant\u00e9 Publique d'Epid\u00e9miologie et de d\u00e9veloppement \/ Unit\u00e9 Inserm : CIC-EC 07","affiliationName":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"05866159X","role":"pi id"},{"title":"SIREN","uri":"130018351","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"laurence.joly@chu-bordeaux.fr","isContact":"Yes"},{"type":"investigator","name":"Val\u00e9riane;LEROY","PILabo":"ISPED- Institut de Sant\u00e9 Publique d'Epid\u00e9miologie et de d\u00e9veloppement \/ Unit\u00e9 INSERM U 897","affiliationName":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"ORCID","uri":"0000-0003-3542-8616","role":"pi id"},{"title":"IdRef","uri":"095373853","role":"pi id"},{"title":"SIREN","uri":"130018351","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"valeriane.leroy@isped.u-bordeaux.fr","isContact":"Yes"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01hq89f96","role":"sponsor id"},{"title":"SIREN","uri":"263305823","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]}]},"distribution_statement":{"contact":[{"name":"Laurence;JOLY-PEDESPAN","email":"laurence.joly@chu-bordeaux.fr","type":"contact","affiliationName":"UNIVERSITE DE BORDEAUX","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/057qpr032","role":"organisation id","title":"ROR"},{"uri":"130018351","role":"organisation id","title":"SIREN"}]},{"name":"Val\u00e9riane;LEROY","email":"valeriane.leroy@isped.u-bordeaux.fr","type":"contact","affiliationName":"UNIVERSITE DE BORDEAUX","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/057qpr032","role":"organisation id","title":"ROR"},{"uri":"130018351","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Prematurity"},{"keyword":"natural history"},{"keyword":"neurosensory troubles"},{"keyword":"physical development anomalies"},{"keyword":"speech and language disorders"},{"keyword":"concentration disorders"},{"keyword":"emotional development anomalies."},{"keyword":"development"},{"keyword":"prognostic factors"},{"keyword":"mobility"}],"topics":[{"topic":"Neurology","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":"Paediatrics","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":"Psychiatry","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3de50dee-da1c-4791-a386-56bca24a5fed"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D011570"}]},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"}],"purpose":"Study the neurologic and physical becoming of highly premature children (birth between 24 and 33 weeks of amenorrhea) at long term (seven years), in the framework of a multi-center study in the Aquitaine region. Natural history, prognostic factors, occurrence of long term neurological sequelae, in particular minor and moderate, the least known.","abstract":"","coll_dates":[{"start":"2003-01-01","end":"2012-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Nouvelle-Aquitaine']","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Infant, Newborn (birth to 28 days)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Infant (28 days to 2 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Child, Preschool (2 to 5 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Child (6 to 12 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Living births, stillborn births between 24-33 weeks of amenorrhea, in the centers participating to the study\",\n    \"clusion_E\": \" congenital abnormalities.\"\n}","data_kind":"['Clinical data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Coherence request after computer data entry. Missing data checked with the original file. Doctors and subjects remainders for follow-up visits.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/mortality"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}","{\"concept\":{\"vocabURI\":\"MeasurementsAndTests.Psychological\",\"vocab\":\"CESSDA\"},\"value\":\"Psychological tests\/clinical scales (depression, cognition, quality of life, etc.)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[500-1000[ individuals","response_rate":"633"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"Data utilization possible for academic teams.","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Additional access condition : analysis before inside the cohort","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"03-05-2012","lastUpdatedAuto":null,"lastUpdatedManual":"10-09-2014","isContributorPI":"No","contributorName":"Val\u00e9rie GARCIA","contributorAffiliation":"UNIVERSITE DE BORDEAUX","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=Aquipage"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Standardized questionnaire of neonatal events and a neurologic check-up at 1, 4, 12, 18, 24 months; then annual neurologic examination until the age of 7. Neurosensory check-up at 9 months. Auditive check-up at 3 years. Cognitive performances and psycho-emotional profile at 12 months of adjusted age, 2, 4 and 7 years. An NRM imaging is scheduled at 18 months if severe or moderate sequelae are detected.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Aquitaine"},"dataTypes":{"clinicalDataDetails":"Clinical examination at inclusion and during the follow-up at 1, 4, 12, 18 and 24 months, then annually (neurologic check-up) Visual check-up (at 9 months and 2 years)Auditive check-up (at 1 and 3 years) Cognitive performance and psycho-emotional profile (at 1, 2, 4 and 7 years of adjusted age)","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}