[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486298":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":32,"centralContacts":37,"locations":42,"responsibleParty":65,"collaborators":10,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":10,"eligibilityCriteria":72,"healthyVolunteers":69,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":10,"studyType":79,"phases":10,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":44,"whyStopped":10,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University Children's Hospital Basel","OTHER",[8,15],{"label":9,"type":10,"description":10,"interventionNames":11},"Infants on mechanical ventilation",null,[12,13,14],"Diagnostic Test: Electrical impedance tomography (EIT)","Diagnostic Test: Forced oscillation technique (FOT)","Diagnostic Test: Saturation oxygenation pressure index (SOPI)",{"label":16,"type":10,"description":10,"interventionNames":17},"Infants on non-invasive respiratory support",[12,14],[19,24,28],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","Electrical impedance tomography (EIT)","EIT is the measurement of impedance changes of the lung against the flow of alternating electrical currents applied to the thorax. The signal of the electrodes is transmitted to a monitor, which enables real-time assessment of lung aeration and changes in lung volume. EIT is able to reconstruct impedance changes with a high temporal resolution and allows calculation of tidal volumes, relative stretch of lung tissue and areas of poor ventilation. Areas with impedance changes of \\\u003C 10 % of the maximum impedance changes are called 'Silent Spaces'.",[9,16],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"Forced oscillation technique (FOT)","FOT enables non-invasive assessment of lung mechanics using sound waves to inform about the respiratory impedance of the respiratory system (Zrs). Reactance of the respiratory system (Xrs) as part of Zrs is a surrogate measure of compliance of the respiratory system. Xrs was previously used to identify optimal PEEP level, i.e., the PEEP at highest compliance equivalent, in newborn infants using a setup requiring research-specific hardware and software. The FOT module integrated in the commercially available neonatal ventilator is routinely used. FOT measurements are performed twice at each PEEP level to assess the reproducibility of the measurements.",[9],{"type":20,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"Saturation oxygenation pressure index (SOPI)","SOPI is assessed non-invasively and calculated from standard monitoring parameters such as PEEP, fraction of inspired oxygen pressure (FiO2) and peripheral oxyhaemoglobin saturation (SpO2) (PEEP x FiO2 x 100) \u002F SpO2). SOPI is used to provide information on ventilation to perfusion ratio dependent on PEEP level.",[9,16],[33],{"name":34,"affiliation":35,"role":36},"Roland Gerull, Dr. med.","Department of Neonatology, University Children's Hospital Basel UKBB","PRINCIPAL_INVESTIGATOR",[38],{"name":34,"role":39,"phone":40,"phoneExt":10,"email":41},"CONTACT","+41 61 70 42 307","Roland.Gerull@ukbb.ch",[43],{"facility":35,"status":44,"city":45,"state":10,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Basel","4031","Switzerland","CH",{"type":50,"coordinates":51},"Point",[52,53],7.57327,47.55839,{"lat":53,"lon":52},[56,57,58,61,63],{"name":34,"role":39,"phone":10,"phoneExt":10,"email":10},{"name":34,"role":36,"phone":10,"phoneExt":10,"email":10},{"name":59,"role":60,"phone":10,"phoneExt":10,"email":10},"Roland Neumann, Dr. med.","SUB_INVESTIGATOR",{"name":62,"role":60,"phone":10,"phoneExt":10,"email":10},"Benjamin Stöcklin, Dr. med.",{"name":64,"role":60,"phone":10,"phoneExt":10,"email":10},"Sven Schulzke, Prof. Dr. med.",{"type":66,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100486298","electrical-impedance-tomography-for-identification-of-optimal-positive-end-expiratory-pressure-in-newborn-infants-100486298",false,"NCT05612256","Electrical Impedance Tomography for Identification of Optimal Positive End-expiratory Pressure in Newborn Infants","Inclusion Criteria:\n\n* 22+0 to 41+6 weeks' gestational age\n* Requiring mechanical ventilation\n* Written informed parental consent\n\nExclusion Criteria:\n\n* Major congenital malformations including lung and cardiac malformations\n* Infants on high frequency oscillatory ventilation\n* Lack of written informed parental consent","ALL","0 Days","28 Days",{"count":77,"type":78},86,"ESTIMATED","OBSERVATIONAL","Electrical impedance tomography (EIT) enables assessment of regional lung ventilation at the bedside. EIT has been safely used in newborn infants to image intrathoracic lung volume patterns as early as from the first minute of life. This prospective single-centre observational study is to identify optimal PEEP in infants on respiratory support by measurements of EIT, FOT and SOPI.",[82],"Positive End-expiratory Pressure (PEEP)",[84,85,86,87,88,89,90,91,92,93],"respiratory support","newborn infants","ventilator induced lung injury (VILI)","mechanical ventilation","electrical impedance tomography (EIT)","forced oscillation technique (FOT)","saturation oxygenation pressure index (SOPI)","ventilation to perfusion ratio","regional lung ventilation patterns","Silent Spaces","2026-05-04",{"date":96,"type":97},"2026-05-08","ACTUAL",{"date":99,"type":97},"2022-12-10",{"date":101,"type":78},"2026-12",{"name":5,"class":6},1]