[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609987":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":56,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":68,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":83,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention (Study) Group","EXPERIMENTAL","Neonates undergoing cardiothoracic surgery (CT) utilizing cardiopulmonary bypass (CPB) who will have active management of their mean arterial pressure (MAP) to keep the MAP above the LLA as measured by a novel autoregulation monitoring modality.",[13],"Device: Surgery with Active MAP Management",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","SHAM_COMPARATOR","Neonates undergoing cardiothoracic surgery (CT) utilizing cardiopulmonary bypass (CPB) who will have management of their MAP by institutional practice without guidance from an autoregulation monitoring modality.",[19],"Other: Surgery without Active MAP Management",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DEVICE","Surgery with Active MAP Management",[9],null,{"type":6,"name":27,"description":17,"armGroupLabels":28,"otherNames":25},"Surgery without Active MAP Management",[15],[30],{"name":31,"affiliation":5,"role":32},"Bradley Marino, MD, MPP, MSSCE, MBA","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Monica Young","CONTACT","216-442-4401","brutonm@ccf.org",[40],{"facility":5,"status":25,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Cleveland","Ohio","44195","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-81.69541,41.4995,{"lat":50,"lon":49},[53,55],{"name":35,"role":36,"phone":54,"phoneExt":25,"email":38},"2164424401",{"name":31,"role":32,"phone":25,"phoneExt":25,"email":25},{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Bradley Marino","Principal Investigator","100609987","brain-autoregulation-research-study-100609987",false,"NCT07221721","Brain Autoregulation Research Study","A Pilot Study to Assess the Feasibility and Safety of Targeting Mean Arterial Pressure to Reduce Intra-operative Hypotension","Inclusion Criteria:\n\n* All neonates (\\\u003C30 days of age)\n* Undergoing cardiothoracic surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* Less than full term (\\\u003C37 weeks gestation)\n* Weight \\\u003C 2.50kg\n* Genetic abnormality or syndrome except heterotaxy syndrome\n* Major non-cardiac anomalies (e.g. congenital diaphragmatic hernia, - omphalocele, holoprosencephaly, anencephaly)","ALL","30 Days",{"count":70,"type":71},130,"ESTIMATED","INTERVENTIONAL",[74],"NA","Randomized, multi-site, study assessing the feasibility of lower limit of autoregulation targeted mean arterial pressure (MAP) vs. standard MAP management in neonates undergoing cardiac surgery with cardiopulmonary bypass. After eligibility screening and consent, subjects will be randomized to either the intervention (study) or control group.",[77,78],"Hypotension During Surgery","Hypotension Postprocedural",[80,81,82],"hypotension","neonates","cardiothoracic surgery with cardiopulmonary bypass","NOT_YET_RECRUITING","2025-10-28",{"date":86,"type":87},"2025-10-30","ACTUAL",{"date":89,"type":71},"2025-11",{"date":91,"type":71},"2028-12",{"name":58,"class":6},1]