[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508968":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":38,"responsibleParty":55,"collaborators":11,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Copenhagen Trial Unit, Center for Clinical Intervention Research","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Cerebral oximetry + usual care","EXPERIMENTAL",null,[13,14],"Device: Cerebral oximetry monitoring device","Other: Usual care",{"label":16,"type":6,"description":17,"interventionNames":18},"Usual care","The control group will receive mechanical ventilation without access to cerebral oximetry and the SafeBoosC treatment guideline. If the newborn is cared for outside the neonatal unit at any time, e.g. during surgery, cerebral oximetry may or may not be used, as decided by the responsible physician there",[14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","Cerebral oximetry monitoring device","Participants in the experimental group will be monitored with cerebral oximetry, if possible before or, as soon as possible and within six hours after initiation of invasive mechanical ventilation. Cerebral oximetry will be continued until 1) the cardio-pulmonary function has been stabilised as indicated by the need for respiratory and circulatory support and evaluated by the responsible physician, 2) extubation, 3) until 28 days after birth, or 4) until death. Randomisation will only direct the use of cerebral oximetry during the first invasive mechanical ventilation episode. Cerebral oximetry will be used to minimise cerebral hypoxia by modifying clinical care according to the SafeBoosC treatment guideline and monitoring as usual.",[9],{"type":6,"name":16,"description":26,"armGroupLabels":27,"otherNames":11},"Treatment as usual",[9,16],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Caroline Kamp, PhD","CONTACT","+45 20 32 41 08","caroline.kamp@ctu.dk",{"name":35,"role":31,"phone":36,"phoneExt":11,"email":37},"Johanne Juul Petersen","+45 28 93 30 35","johanne.juul.petersen@ctu.dk",[39],{"facility":40,"status":41,"city":42,"state":11,"zip":11,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Hospital Universitario 12 de Octubre","RECRUITING","Madrid","Spain","ES",{"type":46,"coordinates":47},"Point",[48,49],-3.70256,40.4165,{"lat":49,"lon":48},[52],{"name":53,"role":31,"phone":11,"phoneExt":11,"email":54},"Doctor","piris.salvador@gmail.com",{"type":56,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":69,"type":70},1610,"ESTIMATED","INTERVENTIONAL",[73],"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.",[76,77],"Hypoxia","Infant, Newborn, Diseases",[79,80,81],"Near-infrared spectroscopy","Randomised clinical trial","Mechanical ventilation","2025-04-23",{"date":84,"type":85},"2025-04-25","ACTUAL",{"date":87,"type":85},"2025-04-11",{"date":89,"type":70},"2029-02-01",{"name":5,"class":6},1]