[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597624":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":27,"locations":33,"responsibleParty":68,"collaborators":18,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":18,"eligibilityCriteria":75,"healthyVolunteers":72,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":18,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":94,"whyStopped":18,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},{"fullName":5,"class":6},"Neola Medical AB","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","EXPERIMENTAL","Lung monitoring with the Neola device",[13],"Device: Lung monitoring with the Neola device",[15],{"type":16,"name":11,"description":11,"armGroupLabels":17,"otherNames":18},"DEVICE",[9],null,[20,24],{"name":21,"affiliation":22,"role":23},"Valerie Chock, M.D., M.S. Epi","Division of Neonatal and Developmental Medicine Stanford University School of Medicine","PRINCIPAL_INVESTIGATOR",{"name":25,"affiliation":26,"role":23},"Vineet Bhandari, MD, DM","Department of Pediatrics The Children's Regional Hospital at Cooper",[28],{"name":29,"role":30,"phone":31,"phoneExt":18,"email":32},"Magnus Johnsson, MSc.","CONTACT","+46336163410","magnus.johnsson@neolamedical.com",[34,52],{"facility":35,"status":18,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Stanford Lucile Packard Children's Hospital Neonatal Intensive Care Unit","Palo Alto","California","94304","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-122.14302,37.44188,{"lat":45,"lon":44},[48,51],{"name":21,"role":30,"phone":49,"phoneExt":18,"email":50},"(650) 497-8800","vchock@stanford.edu",{"name":21,"role":23,"phone":18,"phoneExt":18,"email":18},{"facility":53,"status":18,"city":54,"state":55,"zip":56,"country":39,"countryCode":40,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Cooper Health System","Camden","New Jersey","08103",{"type":42,"coordinates":58},[59,60],-75.11962,39.92595,{"lat":60,"lon":59},[63,67],{"name":25,"role":30,"phone":64,"phoneExt":65,"email":66},"856-342-2000","1006156","bhandari-vineet@cooperhealth.edu",{"name":25,"role":23,"phone":18,"phoneExt":18,"email":18},{"type":69,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100597624","pivotal-study-to-assess-safety-and-performance-of-neola-a-novel-lung-monitoring-device-for-neonates-100597624",false,"NCT07060911","Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates","IInclusion criteria:\n\n* Preterm or term born neonates with gestational age between 26 and 40 weeks\n* Age between 1 day post-natal and 44 weeks corrected gestational age\n* Weight between 1000 g and 3500 g\n* Patient treated at a neonatal intensive care unit.\n* Patient is either on invasive mechanical ventilation, on CPAP or NIPPV or receives respiratory support via high-flow nasal cannula (≥2L\u002Fmin)\n* Signed informed consent prior to any study related procedures by the legal representatives of the patient\n\nExclusion criteria:\n\n* Known cardiopulmonary congenital anomalies\n* Patients with trisomies or other chromosomal abnormality\n* Patients not expected to survive\n* Non-intact skin or other skin conditions (such as skin lesions) that do not allow the use of skin adhesives. (e.g., Bullous impetigo, Staphylococcal scalded skin syndrome, localized lesions of herpes simplex virus)\n* Thorax curvature does not allow placement of the probe sets without air between the surface of the probes and the skin.","ALL","1 Day","44 Weeks",{"count":80,"type":81},22,"ESTIMATED","INTERVENTIONAL",[84],"NA","Pivotal study to assess safety and performance of Neola®, a novel lung monitoring device for neonates",[87,88,89],"RDS of Prematurity","Preterm Birth","Lung Diseases",[91,92,93],"GASMAS","Spectroscopy","Gas absorption spectroscopy","NOT_YET_RECRUITING","2025-07-02",{"date":97,"type":98},"2025-07-11","ACTUAL",{"date":100,"type":81},"2026-03",{"date":102,"type":81},"2027-02",{"name":104,"class":6},"Neola Medical Inc",2]