{"doc_desc":{"title":"Autonomic maturation in neonatal period and early neurologic development: perspective longitudinal cohort study","idno":"FRESH-PEF3658-en","producers":[{"name":"Jean-Claude BARTHELEMY","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3658-en","IDno":{"metadata_no":[{"agency":"PEF","code":"3658"},{"agency":"FReSH","code":"FRESH-PEF3658"}]},"title":"Autonomic maturation in neonatal period and early neurologic development: perspective longitudinal cohort study","alternate_title":"AUBE"},"study_authorization":{"agency":[]},"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":"No"},{"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":"Yes"},{"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":"Yes"}],"oth_id":[{"name":""}],"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":"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":"Neurology","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":"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":"Describe the profile of maturation of the autonomic cardiac system (through time and frequency analysis of the heart rate variability from polysomnographic 24 hours records) during the firsts two years of life (0, 6, 12, 18 and 24 months) in a full-term or premature infants cohort. Secondary objectives: - Correlate in this cohort the autonomic status at birth and the neurological psychomotor becoming at 2 years; - Describe autonomic evolution profile during the firsts two years of life; - According to specific pregnancy criteria; - According to morphometry data; - According to respiratory, cardiac, neurological, digestive, infectious neonatal morbidity criteria; - According to the incidence of severe diseases and rhythmic disorders during the two firsts two years of life.","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":"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    \"level_type_clusion_I\": \"General population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Every child born at the CHU of Saint Etienne, regardless of the terms of birth, hospitalized in a neonatal unit at the moment of the recording (after 37 corrected weeks in case of prematurity) or at the maternity ward.  - Signature of the written consent by the parents or the legal guardians.  - Parents or legal guardians, affiliated to social security or right-holder.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Paraclinical data (non-biological) : Function testing']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Coherence request after computer data entry. Missing data asked back to the patient or a third. Doctors remainders for follow-up visits. Internal quality audit reports every 6 months. Internal audit frequency: Statistics, by data themes. External audit frequency: 3. EIG declaration (serious adverse effects). Patients receive information about the use of their data.']"}},"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\":\"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":"[500-1000[ individuals","response_rate":"6400"},"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\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Data utilization for academic teams and for industrials to be determined.","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":"15-05-2012","lastUpdatedAuto":null,"lastUpdatedManual":"28-02-2014","isContributorPI":"No","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":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Self-questionnaire: manually filled paper questionnaire with double data entry.Interviews: direct data entryClinical examinations: direct data entryData collected: - Pregnancy specific criteria demand the following parameters: # Maternal history (origin, maternal age at birth, hypertension)# Prenatal prevention for neonatal respiratory distress syndrome through steroid use# Type of childbirth (caesarean section or vaginal delivery), gestational age# Intrauterine growth retardation# Social and familiar environment: family status, professional activity, education level of the holders of parents responsibility- Neonatal morphometry criteria are represented by weight, size and head circumference of the child at birth, gender.- Neonatal morbidity criteria needs the following medical information:# Intraventricular hemorrhage defined according to the PAPILE36 (cranial ultrasonography) classification# Periventricular leukomalacia (cranial ultrasonography)# Bronchopulmonary dysplasia (defined through an oxygen dependence test at 36 corrected weeks with possibility of saturation maintenance superior to 90% during 3 hours)# Retinopathy of prematurity according to the international classification (dilated fundus examination in indirect ophthalmoscopy, systematically realized among this population)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Saint-Etienne"},"dataTypes":{"clinicalDataDetails":"Clinical examination at inclusion and during the follow-up at 24 months","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}