[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100439452":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":36,"responsibleParty":52,"collaborators":18,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":18,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":18,"maxAge":62,"enrollmentInfo":63,"targetDuration":18,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prone Group","EXPERIMENTAL","Turn patient in prone position after surfactant administration. After 6 hours turn patient in supine position and perform EIT and LUS.",[13],"Other: Prone positioning",{"label":15,"type":16,"description":17,"interventionNames":18},"Supine Group","NO_INTERVENTION","Leave patient in supine position after surfactant administration. After 6 hours perform EIT and LUS.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Prone positioning","Turn patient in prone position after surfactant administration.",[9],[25],{"name":26,"affiliation":5,"role":27},"Tobias Werther","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":18,"email":32},"CONTACT","+4314040032320","tobias.werther@meduniwien.ac.at",{"name":34,"role":30,"phone":31,"phoneExt":18,"email":35},"Michael Hermon","michael.hermon@meduniwien.ac.at",[37],{"facility":5,"status":38,"city":39,"state":18,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Vienna","1090","Austria","AT",{"type":44,"coordinates":45},"Point",[46,47],16.37208,48.20849,{"lat":47,"lon":46},[50],{"name":26,"role":30,"phone":51,"phoneExt":18,"email":32},"014040032320",{"type":27,"investigatorFullName":26,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Principal Investigator","100439452","infants-with-severe-acute-respiratory-distress-syndrome-the-prone-trial-100439452",false,"NCT05002478","Infants with Severe Acute Respiratory Distress Syndrome: the Prone Trial","Short-Term Effect of Prone Positioning in Infants with Severe Acute Respiratory Distress Syndrome","Inclusion Criteria:\n\n* Patients hospitalized at Pediatric Intensive Care Unit (PICU) or Neonatal Intensive Care Unit (NICU) of the Medical University Vienna.\n* Patients aged \\>36 weeks (corrected gestational age) and \\\u003C24 months.\n* Patient intubated and mechanically ventilated for at least 6 hours, with an expected requirement of invasive ventilatory support for at least 12 hours.\n* Clinical picture strongly suggestive for acute bronchiolitis or pneumonia (fever, fine crackles, prolonged expiration, lung hyperinflation and\u002For findings of new infiltrates consistent with acute pulmonary parenchymal disease on chest X-ray).\n* Severe pediatric acute respiratory distress syndrome (ARDS), defined by OSI ≥12.3 (wean FIO2 to maintain SpO2 ≤ 97% to calculate oxygen saturation index).\n* Written informed consent obtained from parents.\n\nExclusion Criteria:\n\n* Clinical context\n\n  * Need for O2 supplementation to maintain SpO2\\>94% in the 4 weeks preceding hospitalization in the PICU\u002FNICU\n  * Cyanotic congenital heart disease Cardiogenic pulmonary edema\n  * Severe pulmonary hypertension\n  * Untreated pneumothorax\n  * Severe neurological abnormalities\n  * Other severe congenital anomalies such as congenital diaphragmatic hernia\n  * Ongoing cardiopulmonary resuscitation or limitation of life support\n* Contradictions for prone positioning (adapted from Guerin, C., et al., Prone positioning in severe acute respiratory distress syndrome. N Engl J Med, 2013. 368(23): p. 2159-68):\n\n  * Intracranial pressure \\>30 millimeters of mercury (mmHg) in supine position or cerebral perfusion pressure \\\u003C60 mmHg\n  * Massive hemoptysis requiring an immediate surgical or interventional radiology procedure\n  * Tracheal surgery or sternotomy during the previous 15 days\n  * Serious facial trauma or facial surgery during the previous 15 days\n  * Deep venous thrombosis treated for less than 2 days\n  * Cardiac pacemaker inserted in the last 2 days\n  * Unstable spine, femur, or pelvic fractures\n  * Use of extracorporeal membrane oxygenation (ECMO) before inclusion\n  * Lung transplantation\n  * Burns on more than 20% of the body surface\n* Other non-inclusion criteria\n\n  * Indication not to attempt resuscitation\n  * Patient already recruited for other clinical studies\n  * Patients who already received surfactant in the last 4 weeks\n  * Thoracic skin lesions or wounds on the thorax, where the EIT-electrode-belt would be placed","ALL","12 Months",{"count":64,"type":65},14,"ESTIMATED","INTERVENTIONAL",[68],"NA","The main objective is to determine the short-term effect of prone positioning in infants with infection-associated severe acute respiratory distress syndrome. The investigators compare oxygenation parameters and measurements from electrical impedance tomography (EIT) and lung ultrasonography (LUS) in mechanically ventilated infants in prone position versus supine position after surfactant administration.",[71,72,73],"Acute Lung Injury\u002FAcute Respiratory Distress Syndrome (ARDS)","Surfactant Dysfunction","Infant",[75,76,77,78,79],"Acute Respiratory Distress Syndrome","Electrical Impedance Tomography","Lung Ultrasonography","Prone Position","Infants","2024-11-18",{"date":82,"type":83},"2024-11-20","ACTUAL",{"date":85,"type":83},"2022-07-30",{"date":87,"type":65},"2026-12-31",{"name":5,"class":6},1]