Nctid:
NCT06222060
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000038642", "term"=>"Shaken Baby Syndrome"}, {"id"=>"D000013577", "term"=>"Syndrome"}], "ancestors"=>[{"id"=>"D000004194", "term"=>"Disease"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000001930", "term"=>"Brain Injuries"}, {"id"=>"D000006259", "term"=>"Craniocerebral Trauma"}, {"id"=>"D000020196", "term"=>"Trauma, Nervous System"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000014947", "term"=>"Wounds and Injuries"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "asFound"=>"Syndrome", "relevance"=>"HIGH"}, {"id"=>"M24764", "name"=>"Shaken Baby Syndrome", "asFound"=>"Shaken Baby Syndrome", "relevance"=>"HIGH"}, {"id"=>"M5207", "name"=>"Brain Injuries", "relevance"=>"LOW"}, {"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}, {"id"=>"M9349", "name"=>"Craniocerebral Trauma", "relevance"=>"LOW"}, {"id"=>"M22023", "name"=>"Trauma, Nervous System", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>200}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-05-02", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-04", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-26", "studyFirstSubmitDate"=>"2024-01-15", "studyFirstSubmitQcDate"=>"2024-01-15", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-04", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Shaken Baby Syndrome Knowledge", "timeFrame"=>"Week 1, 6", "description"=>"Change in the proportion of correct knowledge about Shaken Baby Syndrome : a higher level of knowledge indicates a better result."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Shaken Baby Syndrome", "Child abuse", "Parental knowledge"], "conditions"=>["Shaken Baby Syndrome"]}, "descriptionModule"=>{"briefSummary"=>"As part of everyday clinical practice, messages about preventing Shaken Baby Syndrome are delivered to young parents in maternity wards. The modality of these messages changes regularly. For example, in the near future, the messages will be delivered by video in addition to the usual practice. The investigators are setting up a prospective observational cohort study in order to evaluate and then monitor the state of knowledge of young parents on shaken baby syndrome."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Parents of newborns in maternity wards", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Parents of newborns in maternity wards\n\nExclusion Criteria:\n\n* Single parent"}, "identificationModule"=>{"nctId"=>"NCT06222060", "briefTitle"=>"Evaluation of Young Parents' Knowledge of Shaken Baby Syndrome in Maternity Wards", "organization"=>{"class"=>"OTHER", "fullName"=>"Centre Hospitalier Universitaire de Saint Etienne"}, "officialTitle"=>"Evaluation of Young Parents' Knowledge of Shaken Baby Syndrome in Maternity Wards", "orgStudyIdInfo"=>{"id"=>"IRBN462023/CHUSTE"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Parents", "description"=>"Couples of parents of newborns", "interventionNames"=>["Other: Questionnaire about Shaken Baby Syndrome"]}], "interventions"=>[{"name"=>"Questionnaire about Shaken Baby Syndrome", "type"=>"OTHER", "description"=>"Knowledge assessment questionnaire completed in the maternity ward by both parents", "armGroupLabels"=>["Parents"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"42000", "city"=>"Saint-Etienne", "status"=>"RECRUITING", "country"=>"France", "contacts"=>[{"name"=>"Aymeric CANTAIS, MD", "role"=>"CONTACT", "email"=>"aymeric.cantais@chu-st-etienne.fr", "phone"=>"(0)477828190", "phoneExt"=>"+33"}, {"name"=>"Floriane MANIOULOUX, resident", "role"=>"SUB_INVESTIGATOR"}, {"name"=>"Aymeric CANTAIS, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"CHU Saint-Etienne", "geoPoint"=>{"lat"=>45.43389, "lon"=>4.39}}], "centralContacts"=>[{"name"=>"Aymeric CANTAIS, MD", "role"=>"CONTACT", "email"=>"aymeric.cantais@chu-st-etienne.fr", "phone"=>"(0)477828134", "phoneExt"=>"+33"}, {"name"=>"Floriane MANIOULOUX, resident", "role"=>"CONTACT", "email"=>"aymeric.cantais@chu-st-etienne.fr", "phone"=>"(0)477828134", "phoneExt"=>"+33"}], "overallOfficials"=>[{"name"=>"Aymeric CANTAIS, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"CHU Saint-Etienne"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Centre Hospitalier Universitaire de Saint Etienne", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
