{"doc_desc":{"title":"\u00c9tude observationnelle multicentrique exploratoire visant \u00e0 \u00e9valuer les suites de l'infection p\u00e9rinatale par le SRAS-COV-2 et son lien avec la voie du NO : l'hypoth\u00e8se de la mini-pubert\u00e9","idno":"FRESH-PEF73964-fr","producers":[{"name":"Vincent PREVOT","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73964-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73964"},{"agency":"FReSH","code":"FRESH-PEF73964"},{"agency":"NCT","code":"NCT04952870"}]},"title":"\u00c9tude observationnelle multicentrique exploratoire visant \u00e0 \u00e9valuer les suites de l'infection p\u00e9rinatale par le SRAS-COV-2 et son lien avec la voie du NO : l'hypoth\u00e8se de la mini-pubert\u00e9","alternate_title":"miniNO-COVID"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Laurent;STORME","firstname":"Laurent","lastname":"STORME","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02ppyfa04","role":"organisation id"},{"title":"SIREN","uri":"265906719","role":"organisation id"}],"email":"","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","PILabo":"","isContact":false},{"name":"Vincent;PREVOT","firstname":"Vincent","lastname":"PREVOT","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"}],"email":"","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"","isContact":false}],"oth_id":[{"name":"Consortium europ\u00e9en","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02ppyfa04","role":"sponsor id"},{"title":"SIREN","uri":"265906719","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"EUROPEAN COMMISSION RESEARCH","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00k4n6c32"}]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[],"topics":[{"topic":"Endocrinologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D004704"}]},{"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"}]},{"topic":"Maladies endocriniennes, nutritionnelles ou m\u00e9taboliques","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/21500692","title":"CIM-11"}]},{"topic":"Troubles mentaux, comportementaux ou neurod\u00e9veloppementaux","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/334423054","title":"CIM-11"}]},{"topic":"Maladies du syst\u00e8me nerveux","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1296093776","title":"CIM-11"}]},{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]}],"purpose":"Comparer les concentrations plasmatiques de l'hormone folliculo-stimulante (FSH) mesur\u00e9es \u00e0 l'\u00e2ge postnatal de 3 mois entre les trois groupes de nouveau-n\u00e9s appari\u00e9s (sur l'\u00e2ge gestationnel \u00e0 la naissance, l'\u00e2ge postnatal et l'insuffisance respiratoire).","abstract":"","coll_dates":[{"start":"2021-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Allemagne","abbreviation":"de","extLink":{"vocab":"ISO","vocabURI":"de"}},{"name":"Suisse","abbreviation":"ch","extLink":{"vocab":"ISO","vocabURI":"ch"}},{"name":"Royaume-Uni","abbreviation":"gb","extLink":{"vocab":"ISO","vocabURI":"gb"}},{"name":"Gr\u00e8ce","abbreviation":"gr","extLink":{"vocab":"ISO","vocabURI":"gr"}},{"name":"Belgique","abbreviation":"be","extLink":{"vocab":"ISO","vocabURI":"be"}}],"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\": \"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\": \"Nouveau-n\u00e9s (24 \u00e0 41 semaines d'\u00e2ge gestationnel) ou jeunes nourrissons (< 3 mois) admis \u00e0 la maternit\u00e9 ou dans le service de n\u00e9onatologie de l'h\u00f4pital Jeanne de Flandre, CHU de Lille avec une infection p\u00e9rinatale \u00e0 COVID-19 d\u00e9finie par : o Infection pr\u00e9natale \u00e0 COVID-19 : femmes enceintes avec un test PCR positif \u00e0 tout moment de la grossesse ; o Infection post-natale \u00e0 COVID-19 : nouveau-n\u00e9s ou jeunes nourrissons (< 3 mois) avec un test PCR positif dans le pharynx ou les selles dans le cadre de leur traitement. o Les nouveau-n\u00e9s (24 \u00e0 41 semaines d'\u00e2ge gestationnel) ou les jeunes nourrissons (< 3 mois) admis \u00e0 la maternit\u00e9 ou dans le service de n\u00e9onatologie de l'h\u00f4pital Jeanne de Flandre, CHU de Lille pour des pathologies cardio-respiratoires s\u00e9v\u00e8res n\u00e9cessitant un traitement par NO inhal\u00e9. o Le groupe contr\u00f4le sans infection p\u00e9rinatale par COVID-19 sera appari\u00e9 au groupe des cas sur l'\u00e2ge gestationnel \u00e0 la naissance (\u00b1 2 semaines de gestation), sur l'\u00e2ge postnatal (\u00b1 3 semaines) et sur l'insuffisance respiratoire. o Pas d'inclusion dans un autre essai pr\u00e9natal ou postnatal ; o Consentement \u00e9crit des deux parents\",\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":[]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d&#x27;exercice lib\u00e9ral']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}","{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Pas d\u2019acc\u00e8s","sources":[],"target_sample_size":"< 500 individus","response_rate":""},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Etude cas-t\u00e9moins"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s aux seules m\u00e9tadonn\u00e9es\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_14cb\"}]}"},"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":"12-02-2021","lastUpdatedAuto":null,"lastUpdatedManual":"07-07-2025","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (Europe)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":true},"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":"Lorsque le patient est inclus dans l'\u00e9tude, un enqu\u00eateur recueille manuellement les donn\u00e9es d\u00e9mographiques, ainsi que les donn\u00e9es relatives \u00e0 l'intervention. Cette collecte est pseudonymis\u00e9e : seules la premi\u00e8re lettre du nom et la premi\u00e8re lettre du pr\u00e9nom apparaissent sur la feuille de collecte.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France, Allemagne, Suisse, Royaume-Uni, Belgique et Gr\u00e8ce"},"dataTypes":{"clinicalDataDetails":"Examen clinique, poids, taille, signes vitaux ; \u00e9valuation de l'audition ; \u00e9valuation olfactive ; synchronisation de la dyade cerveau-cerveau ; \u00e9valuation ASQ-3 et ASQ-SE ; \u00e9chelle de Bayley - III","biologicalDataDetails":"Concentration plasmatique hormone folliculo-stimulante (FSH)\/ hormone lut\u00e9inisante (LH) ; test hormonal (pr\u00e9l\u00e8vement sanguin) - \u0153strog\u00e8ne (femmes) - testost\u00e9rone (hommes) - Hormone anti-m\u00fcll\u00e9rienne AMH (femmes) - Antig\u00e8ne prostatique sp\u00e9cifique PSA (hommes) ; \u00e9valuation des m\u00e9tabolites (pr\u00e9l\u00e8vement sanguin) - glucose, - insuline, - leptine, - nitrates dans l'\u00e9chantillon d'urine ; conseil g\u00e9n\u00e9tique (pr\u00e9l\u00e8vement sanguin pour le d\u00e9pistage g\u00e9n\u00e9tique et \u00e9pig\u00e9n\u00e9tique).","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}