[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639553":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":40,"responsibleParty":58,"collaborators":18,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":18,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":18,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":86,"whyStopped":18,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"King's College Hospital NHS Trust","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Automated oxygen control","EXPERIMENTAL","Automated oxygen titration",[13],"Device: Closed loop automated oxygen control",{"label":15,"type":16,"description":17,"interventionNames":18},"Manual oxygen control","NO_INTERVENTION","Manual oxygen titration",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Closed loop automated oxygen control","The OxyGenie closed-loop oxygen saturation monitoring software (Inspiration Healthcare) uses oxygen saturations from the SpO2 probe attached to the neonate, fed into an algorithm, to automatically adjust the percentage of inspired oxygen to maintain oxygen saturations within the target range. Manual adjustments including the percentage of FiO2 will be allowed at any point during the study if deemed appropriate by the clinical team.",[9],[26],{"name":27,"affiliation":5,"role":28},"Ourania Kaltsogianni","PRINCIPAL_INVESTIGATOR",[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Ourania Kaltsogianni, MD (Res)","CONTACT","+44020 3299 9000","38493","ourania.kaltsogianni@nhs.net",{"name":37,"role":32,"phone":38,"phoneExt":18,"email":39},"Theodore Dassios, Professor","02032994644","theodore.dassios@kcl.ac.uk",[41],{"facility":42,"status":18,"city":43,"state":18,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"King's College Hospital NHS Foundation Trust","London","SE5 9RS","United Kingdom","UK",{"type":48,"coordinates":49},"Point",[50,51],-0.12574,51.50853,{"lat":51,"lon":50},[54,56],{"name":31,"role":32,"phone":33,"phoneExt":55,"email":35},"38494",{"name":57,"role":32,"phone":38,"phoneExt":18,"email":39},"Theodore Dassios, PhD",{"type":59,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100639553","automated-oxygen-control-in-preterms-on-non-invasive-ventilation-100639553",false,"NCT07622563","Automated Oxygen Control in Preterms on Non-invasive Ventilation","Randomised Controlled Trial of Closed-loop Automated Oxygen Control in Preterm Infants Receiving Non-invasive Respiratory Support","Inclusion Criteria:\n\nPreterm infants \\\u003C34 weeks of gestation and at any postnatal age on non-invasive respiratory support including:\n\n* non-invasive positive pressure ventilation (NIPPV)\n* nasal CPAP\n* HHFNC oxygen, either as primary or post extubation respiratory support.\n\nExclusion Criteria:\n\n* Infants with congenital cyanotic heart disease.\n* Infants with other know major congenital abnormalities.","ALL","22 Weeks","34 Weeks",{"count":71,"type":72},76,"ESTIMATED","INTERVENTIONAL",[75],"NA","This randomised controlled trial aims to investigate the effectiveness of closed-loop automated oxygen control (CLAC) in preterm infants receiving non-invasive respiratory support and determine if it reduces the duration of supplementary oxygen treatment and improves achievement of oxygen saturation targets, reduces the incidences of hypoxia and hyperoxia, the number of manual adjustments to the inspired oxygen concentration (FiO2), and adverse outcomes including bronchopulmonary dysplasia (BPD).\n\nThe study will take place at King's College Hospital neonatal intensive care unit (NICU). Parents of preterm infants born at less than 34 weeks of gestation and receiving non-invasive respiratory support will be approached, informed and if appropriate consented to join the trial.\n\nParticipants will be randomised to receiving either automated or manual oxygen control.\n\nThe study will measure outcomes including the duration of supplementary oxygen treatment, the percentage of time spent within oxygen saturation targets, the incidences of hypoxia and hyperoxia, the number of manual FiO2 adjustments required, the overall duration of non-invasive respiratory support and length of neonatal unit stay, and the incidence of BPD at 36 weeks postmenstrual age (PMA). Results will be compared between the two groups.",[78,79,80],"Infant","Premature","Airway Morbidity",[82,83,84,85],"automated oxygen control","non-invasive respiratory support","randomised controled trial","neonates","NOT_YET_RECRUITING","2026-05-27",{"date":89,"type":90},"2026-06-03","ACTUAL",{"date":92,"type":72},"2026-06-01",{"date":94,"type":72},"2027-09",{"name":5,"class":6},1]