[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638796":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":61,"collaborators":63,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":10,"studyType":85,"phases":10,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":97,"whyStopped":10,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Telethon Kids Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Children (\u003C16 years) with confirmed diagnosis of early onset EE or DEE due to any cause",null,"Children (\\\u003C16 years old) with a confirmed diagnosis of early onset epileptic encephalopathy (EE) or Developmental and epileptic encephalopathy (DEE) due to any cause (prior to age 2 years).",[13],"Diagnostic Test: Monitoring of patients using electroencephalogram, a Bispectral Index (BIS) and Sedline monitors.",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","Monitoring of patients using electroencephalogram, a Bispectral Index (BIS) and Sedline monitors.","This is an observational study of children under 16 years of age, who will be fitted with a 21-lead EEG and then, in consecutive random order, a BIS or Sedline monitor with measurements taken for 30 minutes with each monitor, 60 min in total. This will allow pEEG data to be measured against a corresponding continuous EEG.\n\nThe depth of anaesthesia monitors used are Bispectral Index (BIS, Medtronic, Minneapolis, Minnesota, USA) and Sedline (Masimo, Irvine, California, USA).",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Britta S von Ungern-Sternberg, MD, PhD","CONTACT","+61 8 6456 4806","britta.regli-vonungern@health.wa.gov.au",[27,46],{"facility":28,"status":10,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Perth Children's Hospital","Perth","Western Australia","6909","Australia","AU",{"type":35,"coordinates":36},"Point",[37,38],115.8614,-31.95224,{"lat":38,"lon":37},[41,42],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},{"name":43,"role":23,"phone":44,"phoneExt":10,"email":45},"Lliana Slevin, BSc","+61 426 952 977","lliana.slevin@thekids.org.au",{"facility":47,"status":10,"city":48,"state":10,"zip":10,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Hospital das Clinicas, São Paulo, Sao Paulo","São Paulo","Brazil","BR",{"type":35,"coordinates":52},[53,54],-46.63611,-23.5475,{"lat":54,"lon":53},[57],{"name":58,"role":23,"phone":59,"phoneExt":10,"email":60},"Vinícius Quintão, MD PHD","+55 11 2661 5795","vinicius.quintao@hc.fm.usp.br",{"type":62,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[64,67,69],{"name":65,"class":66},"Child and Adolescent Health Service - Perth","OTHER_GOV",{"name":68,"class":6},"Feculdade de Medicina da Universidade de Sao Paulo - Brasil",{"name":70,"class":71},"Hospital das Clínicas de São Paulo - SP","UNKNOWN","100638796","ibis---investigating-reliability-of-bis-and-sedline-monitoring-in-children-with-developmental-and-epileptic-encephalopathies-dee-100638796",false,"NCT07585643","IBIS - Investigating Reliability of BIS and SEDLINE Monitoring in Children With Developmental and Epileptic Encephalopathies (DEE).","IBIS","Inclusion Criteria:\n\n* Children (\\\u003C16 years old) with a confirmed diagnosis of early onset EE or DEE due to any cause (prior to age 2 years).\n\nExclusion Criteria:\n\n* Language barriers impeding data collection\n* Department for Child Protection and Family Support is involved in the care of the child.","ALL","0 Years","15 Years",{"count":83,"type":84},40,"ESTIMATED","OBSERVATIONAL","When children have surgery, anaesthetists carefully monitor the depth of anaesthesia by using sensors on the forehead that measure brain activity, also known as processed electroencephalogram (pEEG). These monitors are routinely used in paediatric anaesthesia; however, investigators do not know if they work accurately in babies and young children with seizure disorders or on anti-seizure medications.\n\nChildren with developmental and epileptic encephalopathies may need anaesthesia for tests or procedures. It is important that their treating doctors understand whether these monitors truly reflect how awake or asleep the children are. This study aims to compare a child's electrical brain activity using two commonly used devices in paediatric anaesthesia with the conventional 21-lead EEG patterns in children with seizure disorders. The results of this research may help improve the safety and perioperative care of children with seizure disorders who require general anaesthesia in the future.",[88,89,90,91],"Epileptic Encephalopathy","Early Infantile Epileptic Encephalopathy","Infantile Spasm","Developmental and Epileptic Encephalopathies",[93,94,95,96],"epileptic encepthalopathy","anaesthesia","PILOT STUDY","MULTICENTRE","NOT_YET_RECRUITING","2026-05-27",{"date":100,"type":101},"2026-05-29","ACTUAL",{"date":103,"type":84},"2026-05-20",{"date":105,"type":84},"2029-06-20",{"name":5,"class":6},2]