[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508613":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":31,"centralContacts":35,"locations":23,"responsibleParty":43,"collaborators":45,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":23,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":23,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":82,"overallStatus":87,"whyStopped":23,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":23},{"fullName":5,"class":6},"Slagelse Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Nebulized isotonic saline","EXPERIMENTAL","5 ml of isotonic saline is administered through a nebulizer with a flow of 10 l oxygen\u002Fmin",[13],"Other: Nebulized isotonic saline",{"label":15,"type":10,"description":16,"interventionNames":17},"Nasal irrigation with isotonic saline","0.5-2 ml isotonic saline in each nostril administered as nasal drops",[18],"Other: Nasal irrigation with isotonic saline",{"label":20,"type":21,"description":22,"interventionNames":23},"No treatment with saline","NO_INTERVENTION","These children will not receive any treatment with isotonic saline, but superficial suctioning of nasal secretions as needed (as part of standard care).",null,[25,28],{"type":6,"name":9,"description":26,"armGroupLabels":27,"otherNames":23},"The intervention will constitute nebulized isotonic saline.",[9],{"type":6,"name":15,"description":29,"armGroupLabels":30,"otherNames":23},"The intervention will constitute isotonic saline administered as nasal drops.",[15],[32],{"name":33,"affiliation":5,"role":34},"Ann-Marie M Schoos, MD, PhD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":23,"email":39},"CONTACT","+45 20681250","annms@regionsjaelland.dk",{"name":41,"role":37,"phone":23,"phoneExt":23,"email":42},"Maren J Rytter, MD, PhD","mjry@regionsjaelland.dk",{"type":44,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[46,48,50,52,54,56],{"name":47,"class":6},"Copenhagen University Hospital at Herlev",{"name":49,"class":6},"Zealand University Hospital",{"name":51,"class":6},"Copenhagen University Hospital, Hvidovre",{"name":53,"class":6},"Holbaek Sygehus",{"name":55,"class":6},"Nordsjaellands Hospital",{"name":57,"class":58},"Nykøbing Falster Hospital","UNKNOWN","100508613","isotonic-saline-for-children-with-bronchiolitis-100508613",false,"NCT05902702","Isotonic Saline for Children With Bronchiolitis","Isotonic Saline for Children With Bronchiolitis - a Randomized Controlled Non-inferiority Trial","Inclusion Criteria:\n\n* Children aged 0-12 months, whose parents give informed consent to participate, with symptoms of bronchiolitis including at least one of:\n\n  * Runny nose\n  * Dry and persistent cough\n  * Labored breathing (tachypnea, retractions, nasal flaring)\n  * Grunting\n  * Cyanosis or apnea\n  * Wheezing or crackles on auscultation\n  * O2 saturations below 92 %\n  * Difficulties feeding\n\nExclusion Criteria:\n\n* Children with cystic fibrosis or other serious congenital lung diseases\n* Children in whom treatment with short-acting beta-2 agonist is initiated (as this is delivered in nebulized isotonic saline).","ALL","1 Day","12 Months",{"count":70,"type":71},300,"ESTIMATED","INTERVENTIONAL",[74],"NA","The goal of this randomized clinical trial is to investigate the optimal supportive treatment of bronchiolitis in infants from 0-12 months of age. The main question\\[s\\] it aims to answer are:\n\n* To investigate whether isotonic saline should be used as supportive treatment for children with bronchiolitis, and if so, identify the optimal route of administration. The primary outcome is duration of hospitalization.\n* To investigate the current epidemiology of the viral pathogens causing bronchitis in children in Denmark, and to assess whether children infected with specific pathogens might benefit from treatment with isotonic saline.\n\nThe children are randomized after inclusion through computer randomization to one of the 3 arms in the study:\n\n1. Nebulized isotonic saline\n2. Nasal irrigation with isotonic saline\n3. No treatment with saline\n\nThe investigators will compare treatment with saline (both methods) with no treatment, and the investigators will also compare the two methods of delivery of saline (nebulized vs. nasal irrigation).",[77,78,79,80,81],"Bronchiolitis","Respiratory Disease","Asthma in Children","Viral Infection","Acute Respiratory Infection",[83,84,85,86],"Nebulized saline","Nasal saline drops","Nasal saline irrigation","Respiratory severity score","NOT_YET_RECRUITING","2023-06-13",{"date":90,"type":91},"2023-06-15","ACTUAL",{"date":93,"type":71},"2023-09",{"date":95,"type":71},"2029-09",{"name":5,"class":6}]