[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100298906":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":48,"responsibleParty":62,"collaborators":32,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":32,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":32,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":87,"whyStopped":32,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Loma Linda University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High flow nasal cannula system w\u002F ADINA","EXPERIMENTAL","The intervention is the insertion of the the ADINA device into the high flow nasal cannula system. ADINA will be placed according to weight class recommendations to increase the positive end expiratory pressure (PEEP). ADINA is actually a combination of the Neotech RAM Cannula and a clear Regulator\u002FPop off valve.",[13],"Device: Adaptive Dynamic Inspiratory Nasal Apparatus",{"label":15,"type":16,"description":17,"interventionNames":18},"high flow nasal cannula system","ACTIVE_COMPARATOR","High flow nasal cannula will deliver oxygen at 2-4 lpm of flow. High flow cannula are used to provide the control interface.",[19],"Device: High flow Nasal Canula",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Adaptive Dynamic Inspiratory Nasal Apparatus","Oxygen will be administered via ADINA",[9],[27],"ADINA",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"High flow Nasal Canula","Oxygen will be administered via nasal canula",[15],null,[34],{"name":35,"affiliation":36,"role":37},"Mitchell R Goldstein, MD","Loma Linda University Health","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},"Tina Ramirez","CONTACT","909-558-5828","TIRameriz@llu.edu",{"name":45,"role":41,"phone":46,"phoneExt":32,"email":47},"Alyssa Taber","909-558-6087","ATaber@llu.edu",[49],{"facility":50,"status":32,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":32},"Loma Linda University Medical Center","Loma Linda","California","92354","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-117.26115,34.04835,{"lat":60,"lon":59},{"type":63,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100298906","adina-vs-high-flow-nasal-cannula-comparison-study-100298906",false,"NCT03171129","ADINA vs. High Flow Nasal Cannula Comparison Study","Adaptive Dynamic Inspiratory Nasal Apparatus (ADINA): Comparison to High Flow Nasal Cannula (HFNC)","Inclusion Criteria:\n\n* Neonates admitted to NICU\n* Weights of 400-500 grams\n* Requiring oxygen greater than 30%\n* No evidence of focal lobar consolidation in lung fields\n\nExclusion Criteria:\n\n* Intolerance to procedure\n* gelatinous skin\n* known allergy to adhesive material\n* interference with therapy\n* profound sepsis\n* pneumonia\n* unmanaged apnea\u002Fbradycardia\n* known or suspect complex congenital heart disease\n* severe cleft lip or palate\n* suspect or proven lethal congenital anomaly\n* intolerance to the interface used in the devices\n* inability to secure an appropriate fit of the patient nasal interface\n* considered non-viable or of uncertain viability\n* parental refusal.","ALL","23 Weeks","40 Weeks",{"count":75,"type":76},40,"ESTIMATED","INTERVENTIONAL",[79],"NA","This study is to evaluate the feasibility of using a pressure limited nasal cannula system instead of a high flow nasal cannula system in the management of premature babies with respiratory distress.",[82],"Respiratory Distress Neonatal",[84,85,86],"Respiratory Distress","Nasal CPAP","high flow nasal canula","NOT_YET_RECRUITING","2026-01-28",{"date":90,"type":91},"2026-01-30","ACTUAL",{"date":93,"type":76},"2026-07",{"date":95,"type":76},"2027-09",{"name":5,"class":6},1]