{"doc_desc":{"title":"Cohorte d'enfants pr\u00e9matur\u00e9s: int\u00e9r\u00eat du sulfate de magnesium dans la pr\u00e9vention des sequelles neuro-d\u00e9veloppementales","idno":"FRESH-PEF60133-fr","producers":[{"name":"St\u00e9phane MARRET","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE ROUEN"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60133-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60133"},{"agency":"FReSH","code":"FRESH-PEF60133"}]},"title":"Cohorte d'enfants pr\u00e9matur\u00e9s: int\u00e9r\u00eat du sulfate de magnesium dans la pr\u00e9vention des sequelles neuro-d\u00e9veloppementales","alternate_title":"PREMAG"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"St\u00e9phane;MARRET","PILabo":"UNIVERSITE DE \/ SERVICE DE PEDIATRIE NEONATALE ET REANIMATION. CHU","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE ROUEN","extlink":[{"title":"ORCID","uri":"0000-0002-2858-148X","role":"pi id"},{"title":"IdRef","uri":"07334933X","role":"pi id"},{"title":"SIREN","uri":"267601680","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"Stephane.marret@chu-rouen.fr","isContact":"Oui"}],"oth_id":[{"name":"Une m\u00e9taanalyse a \u00e9t\u00e9 faite avec les autres \u00e9tudes internationales et a fait l'objet de deux publications Cochrane et une publication dans la revue Obste GynecolDe plus une mise en commun des donn\u00e9es PREMAG avec les autres bases de donn\u00e9es existant dans le monde pour r\u00e9aliser une Individual Personal Data Analysis est en cours de finalisation: Etude AMICABLE voire publication.","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE 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scolaires"},{"keyword":"troubles des apprentissages"},{"keyword":"lunettes"},{"keyword":"leucomalacie p\u00e9riventriculaire"},{"keyword":"troubles cognitifs"}],"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":"Objectif g\u00e9n\u00e9ral : d\u00e9terminer le score cognitif \u00e0 8 ans Objectif secondaire : d\u00e9terminer si l'enfant dispose d'une scolarisation en milieu ordinaire ou specialis\u00e9","abstract":"","coll_dates":[{"start":"1998-01-01","end":"2002-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"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\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"enfants n\u00e9s pr\u00e9matur\u00e9s (inf\u00e9rieur \u00e0 33 semaines)\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude']","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 ou retour vers un tiersRelance des m\u00e9decins pour r\u00e9aliser les visites de suivi Relance des sujets pour r\u00e9aliser les visites de suiviLes patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es']"}},"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\":\"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":"688"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research 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