[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520216":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":62,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":26,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Montefiore Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Non-Invasive Mechanical Servo Ventilation Arm","ACTIVE_COMPARATOR","This arm will utilize a standard mode of non-invasive ventilation within protocol parameters.",[13],"Device: Standard Non-Invasive Mechanical Servo Ventilation",{"label":15,"type":16,"description":17,"interventionNames":18},"Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation Arm","EXPERIMENTAL","This arm with utilize a NAVA mode of non-invasive ventilation within protocol parameters.",[19],"Device: Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Standard Non-Invasive Mechanical Servo Ventilation","The active comparator arm will utilize a standard non-invasive mode to provide ventilation support",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation","The experimental arm will utilize a NAVA mode to provide non-invasive ventilation support",[15],[32],{"name":33,"affiliation":5,"role":34},"Jacqueline Weingarten, MD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","2017459825","jweingar@montefiore.edu",{"name":41,"role":37,"phone":26,"phoneExt":26,"email":42},"Monica Koncicki, MD","mkoncicki@montefiore.org",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Children's Hospital at Montefiore","RECRUITING","The Bronx","New York","10467","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-73.86641,40.84985,{"lat":56,"lon":55},[59],{"name":60,"role":37,"phone":61,"phoneExt":26,"email":26},"Timothy Brandt, MD","718-619-7494",{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100520216","non-invasive-ventilation-versus-neurally-adjusted-ventilatory-assistance-nava-for-the-treatment-of-bronchiolitis-100520216",false,"NCT06053684","Non-Invasive Ventilation Versus Neurally-Adjusted Ventilatory Assistance (NAVA) for the Treatment of Bronchiolitis","Comparison of Conventional Non-Invasive Ventilation and Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Ventilation for the Treatment of Bronchiolitis","Inclusion Criteria:\n\n* Patients under the age of two years old with a diagnosis of bronchiolitis presenting to the pediatric ICU\n* Patient's provider believes there is equipoise between the use of NAVA or conventional non-invasive ventilation for the patient\n\nExclusion Criteria:\n\n* Patients unable to utilize a nasogastric tube\n* Patients with a diagnosis of chronic lung disease, cyanotic heart lesions, or congestive heart failure\n* Patients with hypotonia\n* Patients likely to require imminent intubation: \\>0.60 Fraction of Inspired Oxygen (FiO2); Carbon Dioxide (CO2) \\> 60, frequent apneas, clinician determines patient unlikely to tolerate non-invasive modality)\n* Patients with hemodynamic instability, defined as the need for vasoactive medication","ALL","0 Years","2 Years",{"count":75,"type":76},130,"ESTIMATED","INTERVENTIONAL",[79],"NA","This project aims to answer whether the use of a Neurally-Adjusted Ventilatory Assistance mode for non-invasive ventilation in pediatric patients with bronchiolitis results in improved comfort and reduced escalations in therapy (including intubation) when compared to using a standard mode of non-invasive ventilation. Neurally-Adjusted Ventilatory Assistance (NAVA) has been shown to result in greater synchrony then the standard mode of non-invasive ventilation. The study team hypothesizes that this improved synchrony can result in important clinical improvements when NAVA is used to treat children with bronchiolitis.",[82],"Bronchiolitis","2025-08-28",{"date":85,"type":86},"2025-09-05","ACTUAL",{"date":88,"type":86},"2023-12-18",{"date":90,"type":76},"2027-03",{"name":5,"class":6},1]