[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"airway-morbidity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:airway-morbidity":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":20,"type":21},76,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Infant","Premature","Airway Morbidity",[31,32,33,34],"automated oxygen control","non-invasive respiratory support","randomised controled trial","neonates","NOT_YET_RECRUITING","2026-05-27",{"date":38,"type":39},"2026-06-03","ACTUAL",{"date":41,"type":21},"2026-06-01",{"date":43,"type":21},"2027-09",{"name":45,"class":46},"King's College Hospital NHS Trust","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":47},"100441589","optimising-ventilation-in-preterms-with-closed-loop-oxygen-control-100441589","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",{"count":56,"type":21},70,[24],"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.",[60,29,61],"Infant, Premature, Diseases","Mechanical Ventilation Complication","RECRUITING","2024-10-21",{"date":65,"type":39},"2024-10-23",{"date":67,"type":39},"2021-09-05",{"date":69,"type":21},"2025-03",{"name":45,"class":46}]