[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565036":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":28,"locations":38,"responsibleParty":57,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University Hospital, Rouen","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"passive immunization",null,"Patients having received a passive immunization",[13,14],"Other: biobank","Other: follow up",{"label":16,"type":10,"description":17,"interventionNames":18},"no passive immunization","Patients not having received a passive immunization",[13,14],[20,24],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"biobank","* nasopharyngeal swab collection\n* nasopharyngeal nasal washes collection, during hospitalization, if any",[16,9],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"follow up","\\- one year follow up: after 1 month, 3 months, 6 months et 12 months",[16,9],[29,35],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Hortense PETAT, Doctor","CONTACT","0232888265","+33","secretariat.DRC@chu-rouen.fr",{"name":36,"role":31,"phone":37,"phoneExt":33,"email":34},"Cécile Pourcher","0232888990",[39],{"facility":40,"status":41,"city":42,"state":10,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Rouen University Hospital","RECRUITING","Rouen","76000","France","FR",{"type":47,"coordinates":48},"Point",[49,50],1.09932,49.44313,{"lat":50,"lon":49},[53],{"name":54,"role":31,"phone":55,"phoneExt":33,"email":56},"David Mallet","02 32 88 82 65","secretariat.DRC@chu-rouen.frv",{"type":58,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100565036","viral-epidemiology-of-bronchiolitis-after-nirsevimab-implementation-and-respiratory-evolution-in-infants-100565036",false,"NCT06636955","Viral Epidemiology of Bronchiolitis After Nirsevimab Implementation and Respiratory Evolution in Infants","Viral Epidemiology of Bronchiolitis After NIrsevimab Implementation and Respiratory Evolution in Infants","EBINIR","Inclusion Criteria:\n\n* Infant aged 12 months or less\n* Admitted to the pediatric emergencies services during one of the three epidemic years: 2024-2025, 2025-2026 and 2026-2027\n* With clinical diagnosis of first episode of acute bronchiolitis by the emergency pediatrician\n* With nasopharyngeal swab for virological diagnosis\n\nExclusion Criteria:\n\n* Refusal of one or more of the infants parents to participate in the study\n* Infants parents refused to be called back for follow-up\n* No nasopharyngeal swab taken","ALL","0 Months","12 Months",{"count":71,"type":72},900,"ESTIMATED","OBSERVATIONAL","Acute bronchiolitis in infants, mainly caused by the Respiratory Syncytial Virus (RSV), is a public health issue, in terms of morbidity and hospital costs.\n\nNirsevimab, a long-acting antibody against RSV available for all infants under 12 months, could profoundly modify the epidemiology of the next epidemic seasons, with the increase of the frequency of the other respiratory viruses (endemic Coronaviruses, Metapneumovirus, etc) Monitoring viral ecology is important, as the impact of respiratory infections on morbidity in the short, medium and long term, but also in economic terms.\n\nInfants under the age 12 months with a first episode of bronchiolitis and consulting the emergency pediatric department will be included. A nasopharyngeal swab will be performed as routine care, and clinical data will be collected.\n\nMultiplex Polymerase Chain Reaction will be performed to identify respiratory virus(es) responsible for the bronchiolitis. In hospitalized infants with RSV or rhinovirus positive Polymerase Chain Reaction (PCR), daily nasal washes will be collected to perform viral loads with specific quantitative PCR (nasal washes biobank), associated with daily clinical data. A 12-month follow-up is planned for every infant included, consisting with 4 phone calls, to identify factors associated with the onset of preschool wheezing.\n\nThe main objective is to describe the viral epidemiology associated with acute bronchiolitis leading to a pediatric emergency department visit the implementation of Nirsevimab.",[76],"Acute Bronchiolitis",[78,9,79,80,81],"Nirsevimab","pediatric emergencies","viral epidemiology","acute bronchilitis","2024-10-10",{"date":84,"type":85},"2024-10-15","ACTUAL",{"date":87,"type":85},"2024-10-07",{"date":89,"type":72},"2028-12-31",{"name":5,"class":6},1]