[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100441589":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":39,"responsibleParty":56,"collaborators":58,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":12,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":12,"maxAge":12,"enrollmentInfo":69,"targetDuration":12,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":12,"overallStatus":42,"whyStopped":12,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"King's College Hospital NHS Trust","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Manual oxygen control","NO_INTERVENTION","Standard ventilation with inspired oxygen concentration adjusted manually as per unit's protocol.",null,{"label":14,"type":6,"description":15,"interventionNames":16},"Closed-loop automated oxygen control","Ventilation with Oxygenie software (closed-loop automated oxygen control system), adjusted by clinical staff as necessary",[17],"Device: Closed-loop automated oxygen control (Oxygenie, SLE 6000)",[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"DEVICE","Closed-loop automated oxygen control (Oxygenie, SLE 6000)","The OxyGenie closed-loop oxygen saturation monitoring software (SLE) 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.",[14],[25],{"name":26,"affiliation":27,"role":28},"Anne Greenough, Professor","King's College Hospital\u002F King's College London","PRINCIPAL_INVESTIGATOR",[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Ourania Kaltsogianni, MSc","CONTACT","(+44)02032999000","38495","ourania.kaltsogianni@nhs.net",{"name":37,"role":32,"phone":12,"phoneExt":12,"email":38},"Theodore Dassios, Consultant Neonatologist","theodore.dassios@nhs.net",[40],{"facility":41,"status":42,"city":43,"state":12,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"King's College Hospital NHS Foundation Trust","RECRUITING","London","SE5 9RS","United Kingdom","UK",{"type":48,"coordinates":49},"Point",[50,51],-0.12574,51.50853,{"lat":51,"lon":50},[54],{"name":55,"role":32,"phone":12,"phoneExt":12,"email":35},"Ourania Kaltsogianni",{"type":57,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[59],{"name":60,"class":6},"King's College London","100441589","optimising-ventilation-in-preterms-with-closed-loop-oxygen-control-100441589",false,"NCT05030337","Optimising Ventilation in Preterms With Closed-loop Oxygen Control","Does Closed-loop Automated Oxygen Control Reduce the Duration of Mechanical Ventilation? A Randomised Controlled Trial in Ventilated Preterm Infants","Inclusion Criteria:\n\n* Preterm infants less than 31 weeks completed gestation at birth requiring mechanical ventilation and admitted to King's NICU in the first 48 hours after birth\n\nExclusion Criteria:\n\n* Preterm infants above 31 weeks completed gestation or term born infants\n* Infants with major congenital abnormalities","ALL",{"count":70,"type":71},70,"ESTIMATED","INTERVENTIONAL",[74],"NA","Many premature infants require respiratory support in the newborn period. Mechanical ventilation although life-saving is linked to complications for the lungs and other organs and its duration should be kept to a minimum. The use of supplemental oxygen may also increase the risk of comorbidities such as retinopathy of prematurity. Therefore, oxygen saturation levels and the amount of inspired oxygen concentration provided should be continuously monitored.\n\nOxygen control can be performed manually or with the use of a computer software incorporated into the ventilator that is called 'closed loop automated oxygen control'(CLAC). The software uses an algorithm that automatically adjusts the amount of inspired oxygen to maintain oxygen saturation levels in a target range. Evidence suggests that CLAC increases the time spent in the desired oxygen target range but there are no data to determine the effect on important clinical outcomes. A previous study has also demonstrated that CLAC reduces the inspired oxygen concentration more rapidly when compared to manual control. That could help infants come off the ventilator sooner.\n\nWith this study we want to compare the time preterm infants spend on the ventilator when we use the software to automatically monitor their oxygen levels with those infants whose oxygen is adjusted manually by the clinical team. That could help us understand if the use of automated oxygen control reduces the duration of mechanical ventilation and subsequently the complications related to it.",[77,78,79],"Infant, Premature, Diseases","Airway Morbidity","Mechanical Ventilation Complication","2024-10-21",{"date":82,"type":83},"2024-10-23","ACTUAL",{"date":85,"type":83},"2021-09-05",{"date":87,"type":71},"2025-03",{"name":5,"class":6},1]