{"doc_desc":{"title":"French Cohort on Neonatal Cerebral Artery Infarction","idno":"FRESH-PEF60090-en","producers":[{"name":"St\u00e9phane CHABRIER","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60090-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60090"},{"agency":"FReSH","code":"FRESH-PEF60090"}]},"title":"French Cohort on Neonatal Cerebral Artery Infarction","alternate_title":"AVCNN"},"study_authorization":{"agency":[]},"authoring_entity":[{"name":"St\u00e9phane;CHABRIER","firstname":"St\u00e9phane","lastname":"CHABRIER","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"}],"email":"stephane.chabrier@chu-st-etienne.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"INSERM, CIE3, F-42055 SAINT-ETIENNE","isContact":true}],"oth_id":[{"name":"","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04pn6vp43","role":"sponsor id"},{"title":"SIREN","uri":"264200304","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"APF FRANCE HANDICAP (APF)","extlink":[{"title":"SIREN","uri":"775688732"}]},{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04pn6vp43"},{"title":"SIREN","uri":"264200304"}]},{"name":"FONDATION GARCHES","extlink":[{"title":"SIREN","uri":"482903747"}]},{"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":""}]},"distribution_statement":{"contact":[{"name":"St\u00e9phane;CHABRIER","lastname":"CHABRIER","firstname":"St\u00e9phane","type":"contact","email":"stephane.chabrier@chu-st-etienne.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":"History"},{"keyword":"miscarriage"},{"keyword":"primiparity"},{"keyword":"first gestation"},{"keyword":"twin pregnancy"},{"keyword":"premature rupture of membranes"},{"keyword":"caesarean section"},{"keyword":"foetal distress"},{"keyword":"monitoring"},{"keyword":"medical care"},{"keyword":"reeducation and rehabilitation"},{"keyword":"information"}],"topics":[{"topic":"Physical and Rehabilitation Medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/38e57437-b2cc-4d26-a46e-c5b639c01e5f"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010810"}]},{"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":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"}],"purpose":"General objective: to determine the clinical and biological obstetric-neonatal profile for full-term newborns presenting symptomatic arterial ischaemic stroke. Secondary objectives: - to determine the mechanisms of infarction from obstetric history, laboratory tests and imaging. - To monitor motor, cognitive and epileptic outcomes in children as well as their autonomy and quality of life until primary school.","abstract":"","coll_dates":[{"start":"2003-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","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\": \"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\": \"All participating newborns hospitalised by neonatal and paediatric neurology services. Full-term newborns presenting perinatal arterial ischaemic stroke were included i.e.: - presenting neurological symptoms (convulsions, malaise, hypotonia, impaired vigilance, asymmetric tone or motor skills) in the first 28 days of life; - Brain imaging (by CT or MRI scan) showing appearance of ischaemic-like lesions in an arterial location; - parents or those with parental authority who gave their consent after explanation of the protocol aims and modalities by the local investigating party and who received an explanatory document.\",\n    \"clusion_E\": \"premature births; - asymptomatic neonates i.e. systematic discovery of an immediate pre- or post-natal image abnormality or children presenting with aposteriori cerebral palsy; - children with diffuse hypoxic-ischaemic lesions i.e more than three affected arterial territories or venous infarction; - where clinical and biological follow-up is impossible; - parental refusal to be included in the study or refusal to sign molecular biology consent form.\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Paraclinical data (non-biological) : Imaging']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Quality of life\/health perception"}]},"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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"100"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Data may be used by academic teams To be decided if data may be used by industrial teams.","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"04-08-2014","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"List of publications in HAL","link":"http:\/\/tinyurl.com\/Hal-Publis-AVCnn"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Private non-profit","Public (France)","Private non-profit","Public (France)","Public (France)","Private non-profit"],"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":"Self-administered questionnaire: from a paper questionnaire Interview: from a paper questionnaire Clinical examination: manual input and double data entry Biological analysis: manual input and double data entry","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Multicentric cohort throughout France (39 centres) Geographical area covered: 39 neonatal and paediatric neurology services throughout the metropolitan territory: ANNEMASSE, AULNAY SOUS BOIS, AUXERRE, AVIGNON, BAYONNE, BEAUVAIS, BESAN\u00c7ON, BONDY, BREST, CAHORS, CARCASSONE, CHALON SUR SA\u00d4NE, CLAMART, CLERMONT-FERRAND, CREIL, CR\u00c9TEIL, EVRY, FONTAINEBLEAU, GRENOBLE, LE KREMLIN-BIC\u00caTRE, LILLE, LIMOGES, LYON, MARSEILLES, MONTPELLIER, NANTES, ORSAY), PARIS (ROBERT DEBR\u00c9, SAINT-VINCENT DE PAUL) P\u00c9RIGUEUX, ROUEN, SAINT-DENIS, SAINT-ETIENNE, TOULOUSE, TOURS, VANNES, VERSAILLES, VILLEFRANCHE SUR S\u00c2ONE AND VILLENEUVE SAINT-GEORGES."},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Thrombophilia research for mother and child","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}