{"doc_desc":{"title":"Mother-to-Child Chikungunya virus infection: an ambispective cohort study","idno":"FRESH-PEF23302-en","producers":[{"name":"Patrick GERARDIN","affiliation":"UNIVERSITE DE LA REUNION"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF23302-en","IDno":{"metadata_no":[{"agency":"PEF","code":"23302"},{"agency":"FReSH","code":"FRESH-PEF23302"}]},"title":"Mother-to-Child Chikungunya virus infection: an ambispective cohort study","alternate_title":"CHIMERE"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Patrick;GERARDIN","PILabo":"CHU de La R\u00e9union \/ Inserm \/Universit\u00e9 de La R\u00e9union \/ Union R\u00e9gionale des M\u00e9decins Lib\u00e9raux de l'Oc\u00e9an \/ Centre d'Investigation Clinique (CIC 1410) - ex Centre d'Investigation Clinique - Epid\u00e9miologie Clinique (CIE2)","affiliationName":"UNIVERSITE DE LA REUNION","extlink":[{"title":"ORCID","uri":"0000-0002-3276-5919","role":"pi id"},{"title":"IdRef","uri":"071614257","role":"pi id"},{"title":"SIREN","uri":"199744780","role":"organisation id"},{"title":"RNSR","uri":"200318009S","role":"labo id"}],"email":"patrick.gerardin@chu-reunion.fr","isContact":"Yes"},{"type":"investigator","name":"Xavier;FRITEL","PILabo":"2224Inserm CIC-P 1402 Centre d\u2019Investigation Clinique Plurith\u00e9matique du CHU de Poitiers. http:\/\/cic0802.labo.univ-poitiers.fr \/ Service de Gyn\u00e9cologie-Obst\u00e9trique et M\u00e9decine de la Reproduction, CHU de Poitiers, Universit\u00e9 de Poitiers, Facult\u00e9 de M\u00e9decine et Pharmacie. http:\/\/medphar.univ-poitiers.fr\/CESP UMR Inserm U1018, Equipe 7 : Genre, Sant\u00e9 Sexuelle et Reproductive.","affiliationName":"UNIVERSITE DE POITIERS","extlink":[{"title":"ORCID","uri":"0000-0002-4987-8127","role":"pi id"},{"title":"IdRef","uri":"061113972","role":"pi id"},{"title":"SIREN","uri":"198608564","role":"organisation id"},{"title":"RNSR","uri":"201019083D","role":"labo id"}],"email":"xavier.fritel@chu-poitiers.fr","isContact":"Yes"}],"oth_id":[{"name":"Reacting network for the Chikungunya in French West Indies and Guyana","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/004dan487","role":"sponsor id"},{"title":"SIREN","uri":"200030013","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":"Patrick;GERARDIN","email":"patrick.gerardin@chu-reunion.fr","type":"contact","affiliationName":"UNIVERSITE DE LA REUNION","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/005ypkf75","role":"organisation id","title":"ROR"},{"uri":"199744780","role":"organisation id","title":"SIREN"}]},{"name":"Xavier;FRITEL","email":"xavier.fritel@chu-poitiers.fr","type":"contact","affiliationName":"UNIVERSITE DE POITIERS","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/04xhy8q59","role":"organisation id","title":"ROR"},{"uri":"198608564","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Chikungunya virus"},{"keyword":"pregnancy"},{"keyword":"obstetrics"},{"keyword":"perinatal medicine"},{"keyword":"mother"},{"keyword":"neonate"},{"keyword":"mother-to-child transmission"},{"keyword":"pediatrics"},{"keyword":"children"},{"keyword":"encephalitis"},{"keyword":"encephalopathy"},{"keyword":"neurodevelopmental outcome"},{"keyword":"sequelae"},{"keyword":"cohort studies"}],"topics":[{"topic":"Gynaecology and obstetrics","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7de64596-5b0d-4977-8f98-b982ff2ec17d"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/284ca20c-beb4-4abe-99fa-ef4513358bad"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D006176"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009774"}]},{"topic":"Infectious disease medicine","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":"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"}]}],"purpose":"1- Primary objective: to assess the prevalence and the neurodevelopmental outcomes of maternal-fetal chikungunya infection ; 2-Secundary objectives: to decipher the mechanisms and risk factors of mother-to-child chikungunya virus transmission; to describe the chikungunya virus in the pregnant woman and in the neonate; to propose a guideline for diagnosis and treatment of infections over pregnancy, childbirth and neonatal periods; to valid the virological diagnosis in the neonate using cord blood RT-PCRs; to study viral strains; to describe in children exposed in utero to maternal infection the kinetics of seroreversion of maternal transplacental IgG antibodies.","abstract":"","coll_dates":[{"start":"2005-01-01","end":"2008-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['La R\u00e9union']","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\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    \"level_type_clusion_I\": \"General population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Maternal study: pregnant women with life insurance cover; Child study: children born from women enrolled in t the maternal cohort. Inclusion whatever the pregnancy story and the exposure the first two months, then only the exposed women reporting a chikungunya attack the next six following months.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Socio-demographic data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth 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\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"1433"},"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":"","status":"{\"value\":\"To be defined\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","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":"14-02-2015","lastUpdatedAuto":null,"lastUpdatedManual":"01-10-2018","isContributorPI":"No","contributorName":"Patrick GERARDIN","contributorAffiliation":"UNIVERSITE DE LA REUNION","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.sciencedirect.com\/science\/article\/pii\/S1201971208001586"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Yes"},"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":"Data collected by hospital-based gynecologists-obstetricians, midwives, neonatologists-pediatricians, psychometrists, neuropsychologists in CAMSP centers at the different time-points of follow-up (see above).","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Cohort study conducted in four public maternities: Saint Denis, Saint Louis, Saint Paul, Saint Pierre one semi-public semi-private maternity: Saint Beno\u00eet one private maternity: Sainte Clotilde"},"dataTypes":{"clinicalDataDetails":"Mothers: inclusions, clinical examinations and anthropometric measures during pregnancy and\/or at childbirth. Children: inclusions and clinical examinations and anthropometric measures at birth, 9-12 months (CLAMS and babyvision), 18-24 months (revised Brunet-Lezine DQ)","biologicalDataDetails":"Mothers: blood numeration and formula at childbirth; children: blood numeration and formula at birth","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}