{"doc_desc":{"title":"Etude longitudinale sur des enfants ayant un cath\u00e9ter veineux central","idno":"FRESH-PEF5033-fr","producers":[{"name":"","affiliation":""}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5033-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"5033"},{"agency":"FReSH","code":"FRESH-PEF5033"}]},"title":"Etude longitudinale sur des enfants ayant un cath\u00e9ter veineux central","alternate_title":"PAPRIKA (Programme d\u2019am\u00e9lioration des pratiques Rh\u00f4ne-Alpines contre l\u2019infection sur cath\u00e9ter)"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Karine;BELLEMIN","firstname":"Karine","lastname":"BELLEMIN","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60","role":"organisation id"},{"title":"SIREN","uri":"266900273","role":"organisation id"}],"email":"ka.bellemin@gmail.com","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","PILabo":"HOSPICES CIVILS DE LYON (HCL) \/ Groupement Hospitalier Est, H\u00f4pital Femme-M\u00e8re-Enfant","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"HOSPICES CIVILS DE LYON (HCL)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60","role":"sponsor id"},{"title":"SIREN","uri":"266900273","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"HOSPICES CIVILS DE LYON (HCL)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60"},{"title":"SIREN","uri":"266900273"}]}]},"distribution_statement":{"contact":[{"name":"Karine;BELLEMIN","lastname":"BELLEMIN","firstname":"Karine","type":"contact","email":"ka.bellemin@gmail.com","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01502ca60","role":"organisation id","title":"ROR"},{"uri":"266900273","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"cath\u00e9ters"},{"keyword":"infection"},{"keyword":"r\u00e9animation n\u00e9onatale"},{"keyword":"\u00e9pid\u00e9miologie"},{"keyword":"surveillance"}],"topics":[{"topic":"Infectiologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"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 li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"1) Estimer l\u2019incidence des infections li\u00e9es aux cath\u00e9ters veineux centraux (CVC) pour l\u2019ensemble des \u00e9tablissements de la r\u00e9gion Rh\u00f4ne-Alpes et chacun des \u00e9tablissements 2) Identifier des facteurs de risque d'infection 3) D\u00e9crire les infections li\u00e9es aux CVC.","abstract":"","coll_dates":[{"start":"2007-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Auvergne Rh\u00f4ne-Alpes']","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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Tout enfant hospitalis\u00e9 dans l\u2019un des services participant et ayant, soit un cath\u00e9ter veineux central (CVC) pos\u00e9 dans le service au cours de son s\u00e9jour, soit d\u00e9j\u00e0 un CVC \u00e0 son entr\u00e9e dans le service.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","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\r\nConsommation de soins\/services de sant\u00e9"}]},"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\":\"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":"[1000-10000[ individus","response_rate":"En cours"},"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":"","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":"07-12-2012","lastUpdatedAuto":null,"lastUpdatedManual":"11-09-2017","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":true},"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":"Chaque centre est responsable de l'organisation du recueil des donn\u00e9es le concernant. Les donn\u00e9es sont saisies sur logiciel Epi-Info par les assistants de recherche clinique (ARC). Les donn\u00e9es sont regroup\u00e9es en trois cat\u00e9gories : donn\u00e9es concernant les nouveau-n\u00e9s (\u00e2ge gestationnel, poids \u00e0 la naissance...), donn\u00e9es concernant les cath\u00e9ters veineux centraux (dates de pose et retrait, localisation, utilisation pour nutrition parent\u00e9rale...) et donn\u00e9es concernant les infections (date, germes, r\u00e9sistance...). Un m\u00e9decin hospitalier r\u00e9f\u00e9rent dans chaque centre v\u00e9rifie que toutes les donn\u00e9es ont \u00e9t\u00e9 renseign\u00e9es et compl\u00e8te les fichiers au besoin avec les assistants de recherche clinique (ARC). Suite \u00e0 la saisie, un contr\u00f4le de qualit\u00e9 des donn\u00e9es est effectu\u00e9 dans chaque centre et suivi de corrections au besoin. Une extraction des donn\u00e9es pour l'analyse globale est r\u00e9alis\u00e9e chaque ann\u00e9e. Des extractions par centre sont aussi r\u00e9alis\u00e9es pour un suivi mensuel simplifi\u00e9.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Depuis 2007 dans 2 r\u00e9animations n\u00e9onatales des Hospices Civils de Lyon et \u00e9largie \u00e0 la r\u00e9gion Rh\u00f4ne-Alpes depuis 2011. Au total 11 centres participent actuellement \u00e0 la cohorte."},"dataTypes":{"clinicalDataDetails":"Donn\u00e9es socio-d\u00e9mographiques, morbidit\u00e9, mortalit\u00e9","biologicalDataDetails":"Bact\u00e9riologie (h\u00e9moculture, voie veineuse centrale)","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}