{"doc_desc":{"title":"Cohorte d'enfants hospitalis\u00e9s en n\u00e9onatologie : maturation autonomique et d\u00e9veloppement neurologique pr\u00e9coce","idno":"FRESH-PEF3658-fr","producers":[{"name":"Jean-Claude BARTHELEMY","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3658-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"3658"},{"agency":"FReSH","code":"FRESH-PEF3658"}]},"title":"Cohorte d'enfants hospitalis\u00e9s en n\u00e9onatologie : maturation autonomique et d\u00e9veloppement neurologique pr\u00e9coce","alternate_title":"AUBE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Jean-Claude;BARTHELEMY","PILabo":"CENTRE HOSPITALIER UNIVERSITAIRE DE \/ Service de physiologie Clinique et de l'exercice","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","extlink":[{"title":"ORCID","uri":"0000-0003-4306-7275","role":"pi id"},{"title":"IdRef","uri":"030974895","role":"pi id"},{"title":"SIREN","uri":"264200304","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"Non"},{"type":"investigator","name":"Hugues;PATURAL","PILabo":"CENTRE HOSPITALIER UNIVERSITAIRE DE \/ P\u00f4le m\u00e8re enfants, unit\u00e9 de soins intensifs et n\u00e9onatologieService de physiologie Clinique et de l'exercice","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","extlink":[{"title":"ORCID","uri":"0000-0002-5359-6544","role":"pi id"},{"title":"IdRef","uri":"142302279","role":"pi id"},{"title":"SIREN","uri":"264200304","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"hugues.patural@chu-st-etienne.fr","isContact":"Oui"},{"type":"investigator","name":"Georges;TEYSSIER","PILabo":"CENTRE HOSPITALIER UNIVERSITAIRE DE \/ P\u00f4le m\u00e8re enfants, unit\u00e9 de soins intensifs et n\u00e9onatologie","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"060328517","role":"pi id"},{"title":"SIREN","uri":"264200304","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"georges.teyssier@chu-st-etienne.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"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":"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":"Hugues;PATURAL","email":"hugues.patural@chu-st-etienne.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/04pn6vp43","role":"organisation id","title":"ROR"},{"uri":"264200304","role":"organisation id","title":"SIREN"}]},{"name":"Georges;TEYSSIER","email":"georges.teyssier@chu-st-etienne.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/04pn6vp43","role":"organisation id","title":"ROR"},{"uri":"264200304","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[],"topics":[{"topic":"Neurologie","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":"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"}]}],"purpose":"D\u00e9crire le profil de maturation du contr\u00f4le autonomique cardiaque (par analyse temporelle et fr\u00e9quentielle de la variabilit\u00e9 cardiaque issue d'enregistrements polysonnographiques de 24 heures), au cours des deux premi\u00e8res ann\u00e9es de vie (0, 6, 12, 18, et 24 mois) dans une cohorte de nouveaux-n\u00e9s \u00e0 terme ou pr\u00e9matur\u00e9s. Objectifs secondaires: - corr\u00e9ler dans cette cohorte le statut autonomique \u00e0 la naissance au devenir neurologique psychomoteur \u00e0 2 ans; - D\u00e9crire le profil d'\u00e9volution autonomique au cours des deux premi\u00e8res ann\u00e9es de vie; - Selon les crit\u00e8res sp\u00e9cifiques de la grossesse; - Selon les donn\u00e9es de morphom\u00e9trie; - Selon les crit\u00e8res de morbidit\u00e9 n\u00e9onatale respiratoire, cardiaque, neurologique, digestive, infectieuse; - selon l'incidence des malaises graves et des troubles rythmiques les deux premi\u00e8res ann\u00e9es de vie.","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2013-01-01"}],"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    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" Tout enfant n\u00e9 au CHU de St-Etienne quelque soit son terme de naissance hospitalis\u00e9 dans une unit\u00e9 de n\u00e9onatologie au moment de l'enregistrement (apr\u00e8s 37 semaines corrig\u00e9es en cas de pr\u00e9maturit\u00e9) ou en maternit\u00e9. - Signature du consentement \u00e9clair\u00e9 par les parents ou les titulaires de l'autorit\u00e9 parentale - parents ou titulaires de l'autorit\u00e9 parentale, affili\u00e9s ou ayant-droit d'un r\u00e9gime de s\u00e9curit\u00e9 sociale.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es paracliniques (hors biologiques) : Exploration fonctionnelle']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['- Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques.- Gestion des donn\u00e9es manquantes par retour vers le patient et\/ou par retour vers un tiers.- Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi.- R\u00e9alisation d\\'audit qualit\u00e9 interne tous les 6 mois.- D\u00e9claration des EIG (Ev\u00e9nements Ind\u00e9sirables Graves).- Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es par \u00e9crit.']"}},"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"}]},"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":"[500-1000[ individus","response_rate":"6400"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"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 des donn\u00e9es par des \u00e9quipes acad\u00e9miques ou 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":"15-05-2012","lastUpdatedAuto":null,"lastUpdatedManual":"28-02-2014","isContributorPI":"Non","contributorName":"Hugues PATURAL","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=(+((aube+OR+neurologic+development+OR+autonomic+maturation)+AND+(Patural+H%5BAuthor%5D+OR+Barthelemy+JC%5BAuthor%5D+OR+Teyssier+G%5BAuthor%5D)+NOT+animal"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Auto-questionnaire : saisie manuelle \u00e0 partir d\u2019un questionnaire papier avec double saisie.Entretiens : saisie directe.Examens cliniques : saisie directe.Donn\u00e9es recueillies:- Les crit\u00e8res sp\u00e9cifiques de la grossesse n\u00e9cessitent l'acquisition des param\u00e8tres suivants: # Histoire maternelle (origine, \u00e2ge maternel \u00e0 la naissance, parit\u00e9 maternelle, hypertension) # Pr\u00e9vention pr\u00e9natale de la d\u00e9tresse respiratoire n\u00e9onatale par la prise de st\u00e9ro\u00efdes # Modalit\u00e9 de l'accouchement (c\u00e9sarienne ou voie basse), \u00e2ge gestationnel # Retard de croissance intra-ut\u00e9rin # Environnement social et familial: statut familial, activit\u00e9 professionnelle, niveau d'\u00e9ducation des titulaires de l'exercice de l'autorit\u00e9 parentale- Les crit\u00e8res de morphom\u00e9trie n\u00e9onatale sont repr\u00e9sent\u00e9s par le poids, la taille, et le p\u00e9rim\u00e8tre cr\u00e2nien de l'enfant \u00e0 la naissance, le sexe.- Les crit\u00e8res de morbidit\u00e9 n\u00e9onatale n\u00e9cessitent les renseignements m\u00e9dicaux suivants: # h\u00e9morragie intra ventriculaire d\u00e9finie selon la classification de PAPILE36 (\u00e9chographie transfontanellaire) # leucomalacie p\u00e9ri-ventriculaire (\u00e9chographie transfontanellaire) # dysplasie bronchopulmonaire (d\u00e9fine par un test d'oxyg\u00e9no d\u00e9pendance \u00e0 36 semaines corrig\u00e9es avec possibilit\u00e9 de maintien de saturation sup\u00e9rieure \u00e0 90% pendant 3 heures) # r\u00e9tinopathie du pr\u00e9matur\u00e9 selon classification internationale (fond d\u2019\u0153il en ophtalmoscopie indirecte r\u00e9alis\u00e9 en syst\u00e9matique dans cette population)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Saint-Etienne"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi \u00e0 24 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