[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Copenhagen Trial Unit, Center for Clinical Intervention Research\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100508968","phase-3-safeguarding-the-brain-of-our-smallest-children-iiiv-safeboosc-iiiv-100508968",false,"NCT05907317","Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)","Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv): Cerebral Oximetry Versus Usual Care in Mechanically Ventilated Newborns","SafeBoosC-IIIv","Inclusion Criteria:\n\n* Gestational age more than or equal to 28+0\n* Postnatal age less than 28 days\n* Expected to receive invasive mechanical ventilation (intubation) for at least 24 hours, as judged by the physician intending to randomise\n* Parental informed consent unless the centre has chosen to use 'opt-out' or deferred consent as consent method\n* A cerebral oximeter available so monitoring can be started within six hours after initiation of invasive mechanical ventilation\n\nExclusion Criteria:\n\n* Suspicion of or confirmed brain injury or disorder (e.g. severe hypoxic-ischemic encephalopathy, intraventricular haemorrhage grade 3 or 4, cerebral malformation, genetic or metabolic disease)\n* Suspicion or diagnosis of congenital heart malformations likely to require surgery","ALL","0 Days","28 Days",{"count":21,"type":22},1610,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The objective of the SafeBoosC-IIIv trial is to assess benefits and harms of cerebral oximetry in newborns receiving invasive mechanical ventilation. The hypothesis is that:\n\ni. Cerebral oximetry added to usual care versus usual care alone in newborns receiving invasive mechanical ventilation will increase the number of hospital-free days within 90 days of randomisation.\n\nii. The intervention will decrease a composite outcome of death or moderate to severe neurodevelopmental disability and\u002For increase the mean PARCA-R non-verbal cognitive score at two years of corrected age.",[28,29],"Hypoxia","Infant, Newborn, Diseases",[31,32,33],"Near-infrared spectroscopy","Randomised clinical trial","Mechanical ventilation","RECRUITING","2025-04-23",{"date":37,"type":38},"2025-04-25","ACTUAL",{"date":40,"type":38},"2025-04-11",{"date":42,"type":22},"2029-02-01",{"name":44,"class":45},"Copenhagen Trial Unit, Center for Clinical Intervention Research","OTHER",""]