{"doc_desc":{"title":"Exploratory multicenter observational study to assess the outcome of infants with perinatal SARS-COV-2 infection and its link with the NO pathway: the minipuberty hypothesis","idno":"FRESH-PEF73964-en","producers":[{"name":"Vincent PREVOT","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73964-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73964"},{"agency":"FReSH","code":"FRESH-PEF73964"},{"agency":"NCT","code":"NCT04952870"}]},"title":"Exploratory multicenter observational study to assess the outcome of infants with perinatal SARS-COV-2 infection and its link with the NO pathway: the minipuberty hypothesis","alternate_title":"miniNO-COVID"},"study_authorization":{"agency":[]},"authoring_entity":[{"name":"Laurent;STORME","firstname":"Laurent","lastname":"STORME","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02ppyfa04","role":"organisation 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metabolic diseases","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/21500692","title":"CIM-11"}]},{"topic":"Mental, behavioural or neurodevelopmental disorders","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/334423054","title":"CIM-11"}]},{"topic":"Diseases of the nervous system","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":"To compare the follicle stimulating hormone (FSH) plasma concentrations measured at the postnatal age of 3 months between the three matched (on gestational age at birth, postnatal age and respiratory failure) newborn infants groups","abstract":"","coll_dates":[{"start":"2021-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Germany","abbreviation":"de","extLink":{"vocab":"ISO","vocabURI":"de"}},{"name":"Switzerland","abbreviation":"ch","extLink":{"vocab":"ISO","vocabURI":"ch"}},{"name":"United Kingdom","abbreviation":"gb","extLink":{"vocab":"ISO","vocabURI":"gb"}},{"name":"Greece","abbreviation":"gr","extLink":{"vocab":"ISO","vocabURI":"gr"}},{"name":"Belgium","abbreviation":"be","extLink":{"vocab":"ISO","vocabURI":"be"}}],"geog_coverage":"","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            \"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\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"o Newborn infants (24 to 41 weeks gestational age) or young infants (< 3 months) admitted at the maternity ward or at the Department of Neonatology at Jeanne de Flandre Hospital, CHU of Lille with perinatal COVID-19 infection defined by: o Antenatal COVID-19 infection: pregnant women with positive PCR test at any time of the pregnancy; o Post-natal COVID-19 infection: newborn or young infants (< 3 months) with positive PCR test in pharynx or stools as part of their treatment. o Newborn infants (24 to 41 weeks gestational age) or young infants (< 3 months) admitted at the maternity ward or at the Department of Neonatology at Jeanne de Flandre Hospital, CHU of Lille for severe cardiorespiratory diseases requiring inhaled NO treatment. o The control group without perinatal COVID-19 infection will be matched to thevtreatment group on gestational age at birth (\u00b1 2 weeks of gestation), on postnatal age (\u00b1 3 weeks) and respiratory failure. o No inclusion in another ante- or post-natal trial; o Written consents from both parents;\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Biological 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This collection is pseudonymized: only the first letter of the name and the first letter of the first name appear on the collection sheet.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France, Germany, Switzerland, UK, Belgium and Greece"},"dataTypes":{"clinicalDataDetails":"Clinical examination, body weight, size, vital signals; Clinical examination; Hearing evaluation Olfactive assessement; Brain-to-brain dyad synchrony; ASQ-3 and ASQ-SE assessment; Bayley scale - III","biologicalDataDetails":"FSH\/LH plasma concentration; Hormonal test (blood sampling) - Estrogen (females) - Testosterone (males) - AMH (females) - PSA (males); Metabolite assessment (blood sampling) - Glucose, - Insulin, - Leptin, - Nitrates in urine sample; Genetic counseling (blood sampling for genetic and epigenetic screening)","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}