{"doc_desc":{"title":"Etude longitudinale sur l\u2019infarctus c\u00e9r\u00e9bral art\u00e9riel du nouveau-n\u00e9","idno":"FRESH-PEF60090-fr","producers":[{"name":"St\u00e9phane CHABRIER","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60090-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60090"},{"agency":"FReSH","code":"FRESH-PEF60090"}]},"title":"Etude longitudinale sur l\u2019infarctus c\u00e9r\u00e9bral art\u00e9riel du nouveau-n\u00e9","alternate_title":"AVCnn"},"study_authorization":{"agency":[{"name":"CNIL"}]},"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":"Inclusion dans un projet europ\u00e9en : EUROPEAN PAEDIATRIC STROKE REGISTRY EN COURS DE (RE)CONSTRUCTION","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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":"ant\u00e9c\u00e9dents"},{"keyword":"fausse couche"},{"keyword":"primiparit\u00e9"},{"keyword":"primigestit\u00e9"},{"keyword":"grossesse g\u00e9mellaire"},{"keyword":"rupture pr\u00e9matur\u00e9e des membranes"},{"keyword":"c\u00e9sarienne"},{"keyword":"souffrance f\u0153tale aigu\u00eb"},{"keyword":"information"},{"keyword":"prise en charge m\u00e9dicale"},{"keyword":"r\u00e9\u00e9ducative et de r\u00e9adaptation"},{"keyword":"surveillance"}],"topics":[{"topic":"M\u00e9decine physique et de r\u00e9adaptation","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":"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 biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : d\u00e9terminer le profil obst\u00e9trico-n\u00e9onatal clinique et biologique des nouveau-n\u00e9s \u00e0 terme ayant pr\u00e9sent\u00e9 un infarctus c\u00e9r\u00e9bral art\u00e9riel symptomatique. Objectifs secondaires : - d\u00e9terminer les m\u00e9canismes de l\u2019infarctus \u00e0 partir de l\u2019histoire obst\u00e9tricale, des examens biologiques et de l\u2019imagerie. - suivre l\u2019\u00e9volution motrice, cognitive et \u00e9pileptique des enfants ainsi que leur autonomie et leur qualit\u00e9 de vie jusqu\u2019\u00e0 l\u2019\u00e9cole primaire.","abstract":"","coll_dates":[{"start":"2003-01-01"}],"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\": \"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\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Ensemble des nouveau-n\u00e9s hospitalis\u00e9s dans les services de n\u00e9onatologie et de neurologie p\u00e9diatrique participants. Ont \u00e9t\u00e9 inclus les nouveau-n\u00e9s \u00e0 terme ayant pr\u00e9sent\u00e9 un infarctus c\u00e9r\u00e9bral art\u00e9riel p\u00e9rinatal, c\u2019est \u00e0 dire : - ayant pr\u00e9sent\u00e9 une symptomatologie neurologique (convulsion, malaise, hypotonie, alt\u00e9ration de la vigilance, asym\u00e9trie du tonus ou de la motricit\u00e9) dans les 28 premiers jours de vie ; - dont l\u2019imagerie enc\u00e9phalique (par scanner x ou r\u00e9sonance magn\u00e9tique) montrait des l\u00e9sions d\u2019allure isch\u00e9mique en rapport avec une localisation art\u00e9rielle ; - dont les parents ou titulaires de l\u2019autorit\u00e9 parentale ont donn\u00e9 leur accord apr\u00e8s explication des buts et modalit\u00e9s du protocole par l\u2019investigateur local et remise de la notice explicative. \",\n    \"clusion_E\": \"pr\u00e9matur\u00e9s ; - nouveau-n\u00e9s asymptomatiques, c\u2019est \u00e0 dire en cas de d\u00e9couverte syst\u00e9matique d\u2019une anomalie d\u2019imagerie en p\u00e9riode pr\u00e9 ou post-natale imm\u00e9diate ou enfants pr\u00e9sentant a posteriori une infirmit\u00e9 motrice c\u00e9r\u00e9brale ; - enfants ayant pr\u00e9sent\u00e9 des l\u00e9sions hypoxiques-isch\u00e9miques diffuses, c\u2019est \u00e0 dire plus de trois territoires art\u00e9riels atteints ou un infarctus veineux ; - suivi clinique et biologique impossible ; - refus parental d\u2019\u00eatre inclus dans l\u2019\u00e9tude ou refus de signature du consentement de biologie mol\u00e9culaire\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Gestion des donn\u00e9es manquantes : retour au dossier source, vers le patient, vers un tiersRelance des m\u00e9decins pour r\u00e9aliser les visites de suivi Relance des sujets pour r\u00e9aliser les visites de suiviLes patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Qualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"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":"< 500 individus","response_rate":"100"},"method_notes":"Etude observationnelle","study_class":"Inconnu","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":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques Utilisation possible des donn\u00e9es par des industriels \u00e0 d\u00e9terminer","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":"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":["Priv\u00e9 \u00e0 but non lucratif","Public (France)","Priv\u00e9 \u00e0 but non lucratif","Public (France)","Public (France)","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["","","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":true},"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":"Auto-questionnaire : saisie \u00e0 partir d\u2019un questionnaire papier Entretiens : saisie \u00e0 partir d\u2019un questionnaire papier Examens cliniques : saisie manuelle avec double saisie Examens biologiques : saisie manuelle avec double saisie","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Cohorte multicentrique (39 centres) Fran\u00e7aise Couverture g\u00e9ographique : 39 services de n\u00e9onatologie et de neurologie p\u00e9diatrique r\u00e9partis sur le territoire m\u00e9tropolitain: 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, MARSEILLE, 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 ETVILLENEUVE SAINT-GEORGES."},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi Informations recueillies lors de l'examen clinique : examen clinique standard de l'enfant : poids, taille, p\u00e9rim\u00e8tre cr\u00e2nien, examen neurologique","biologicalDataDetails":"Recherche d\u2019une thrombophilie pour l\u2019enfant et sa m\u00e8re","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}