[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482776":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":46,"responsibleParty":239,"collaborators":242,"id":246,"slug":247,"hasResults":248,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":248,"sex":254,"minAge":255,"maxAge":256,"enrollmentInfo":257,"targetDuration":41,"studyType":260,"phases":261,"briefSummary":263,"conditions":264,"keywords":266,"overallStatus":63,"whyStopped":41,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":283},{"fullName":5,"class":6},"University of Washington","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ICP monitoring based Protocol","ACTIVE_COMPARATOR","Arm one will use a consensus-developed management protocol for paediatric severe traumatic brain injury based on recommendations from the Brain Trauma Foundation Guidelines, which uses invasive intracranial pressure monitoring",[13],"Other: ICP",{"label":15,"type":10,"description":16,"interventionNames":17},"No ICP Monitoring Protocol CREVICE","Arm two will use the Consensus-Revised Imaging and Clinical Examination (CREVICE) management protocol for paediatric severe traumatic brain injury based on imaging and clinical examination in the absence of invasive intracranial pressure monitoring",[18],"Other: CREVICE",[20,26],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"ICP","The intervention is a management protocol that includes ICP monitoring for children with severe traumatic brain injury",[9],[25],"Intracranial-pressure-monitoring-based management protocol",{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"CREVICE","The intervention is a management protocol that is based on imaging and clinical examinations without ICP monitoring for children with severe traumatic brain injury",[15],[31],"Imaging-and-clinical-examination-based management protocol",[33],{"name":34,"affiliation":5,"role":35},"Randall Chesnut, MD","PRINCIPAL_INVESTIGATOR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Randall M Chesnut, MD","CONTACT","2067449322",null,"chesnutr@uw.edu",{"name":44,"role":39,"phone":40,"phoneExt":41,"email":45},"Kelley Chaddock, BA","chaddk@uw.edu",[47,61,84,101,120,139,156,173,192,211,225],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":41},"University of Washington, Harborview Medical Center","NOT_YET_RECRUITING","Seattle","Washington","98104","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-122.33207,47.60621,{"lat":59,"lon":58},{"facility":62,"status":63,"city":64,"state":41,"zip":41,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Fundación Hospital de la Misericordia","RECRUITING","Bogotá","Colombia","CO",{"type":56,"coordinates":68},[69,70],-74.08175,4.60971,{"lat":70,"lon":69},[73,77,81],{"name":74,"role":39,"phone":75,"phoneExt":41,"email":76},"Juan David Roa Giraldo, MD","3013380506","Jdroag@gmail.com",{"name":78,"role":39,"phone":79,"phoneExt":41,"email":80},"Wenci Camilo Navarro, MD","3004576234","Camilosuescun18@gmail.com",{"name":82,"role":83,"phone":41,"phoneExt":41,"email":41},"Orlando Faber Rincón, MD","SUB_INVESTIGATOR",{"facility":85,"status":63,"city":86,"state":41,"zip":41,"country":65,"countryCode":66,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Hospital Fundacion Amigos de la 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Escuela","Tegucigalpa","Honduras","HN",{"type":56,"coordinates":179},[180,181],-87.20681,14.0818,{"lat":181,"lon":180},[184,188],{"name":185,"role":39,"phone":186,"phoneExt":41,"email":187},"Sandra Rodriguez, MD","50499983875","sandra.rodriguez@unah.edu.hn",{"name":189,"role":39,"phone":190,"phoneExt":41,"email":191},"Sandra Flores, MD","50499077099","floresirias@yahoo.es",{"facility":193,"status":63,"city":194,"state":41,"zip":41,"country":195,"countryCode":196,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Hospital de Emergencias Pediátricas","Lima","Peru","PE",{"type":56,"coordinates":198},[199,200],-77.02824,-12.04318,{"lat":200,"lon":199},[203,207],{"name":204,"role":39,"phone":205,"phoneExt":41,"email":206},"Grimaldo C Ramirez, MD","+51 997 294 904","gramirezcortez61@gmail.com",{"name":208,"role":39,"phone":209,"phoneExt":41,"email":210},"Yhuri Carreazo, MD","+51 997252543","yhuroc@gmail.com",{"facility":212,"status":63,"city":194,"state":41,"zip":41,"country":195,"countryCode":196,"cosmosGeoPoint":213,"geoPoint":215,"contacts":216},"Hospital Edgardo Rebagliati Martins",{"type":56,"coordinates":214},[199,200],{"lat":200,"lon":199},[217,221],{"name":218,"role":39,"phone":219,"phoneExt":41,"email":220},"Manuel Munaico, MD","51948418590","munakusqayku@gmail.com",{"name":222,"role":39,"phone":223,"phoneExt":41,"email":224},"Manuel Ortiz, MD","51987817613","manortizch@hotmail.com",{"facility":226,"status":63,"city":194,"state":41,"zip":41,"country":195,"countryCode":196,"cosmosGeoPoint":227,"geoPoint":229,"contacts":230},"Instituto Nacional de Salud del Niño - San Borja",{"type":56,"coordinates":228},[199,200],{"lat":200,"lon":199},[231,235],{"name":232,"role":39,"phone":233,"phoneExt":41,"email":234},"Daniel Achante, MD","51961090970","danielanchante@hotmail.com",{"name":236,"role":39,"phone":237,"phoneExt":41,"email":238},"Patrick Caqui, MD","51933160526","patrickdannycaquivilca@gmail.com",{"type":35,"investigatorFullName":240,"investigatorTitle":241,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Randall M. Chesnut","Professor, School of Medicine",[243],{"name":244,"class":245},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100482776","benchmark-evidence-led-by-latin-america-trial-of-intracranial-pressure---pediatrics-100482776",false,"NCT05566431","Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics","Pediatric Severe Traumatic Brain Injury in Latin America - A Randomized Trial Comparing Two Management Protocols","BELA TRIPP","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form by the parent(s) or guardian(s)\n2. Non-penetrating TBI\n3. Admission to study hospital within 24 hours of injury\n4. Total GCS score ≤ 8 on admission or within first 48 hours after injury (measured using pediatric GCS 1 for children \\\u003C 2 years old and standard GCS for older children)\n5. Age 1 through 12 years\n6. Able to randomize:\n\n   * Within 24 hours of injury (for patients with GCS ≤ 8 on admission) OR\n   * Within 24 hours of deterioration (for patients deteriorating to GCS ≤ 8 within 48 hours of injury)\n\nExclusion Criteria:\n\n1. Motor GCS score of 6\n2. GCS of 3 with bilaterally fixed and dilated pupils\n3. Injury thought to be intentionally inflicted by a family member or caregiver.","ALL","1 Year","12 Years",{"count":258,"type":259},428,"ESTIMATED","INTERVENTIONAL",[262],"NA","Narrative:\n\nWorldwide, traumatic brain injury (TBI) is a leading cause of death and disability among children and adolescents. The Investigators aim to test whether pediatric TBI treatment guided by invasive intracranial pressure monitoring produces better patient outcomes than care guided by a protocol without invasive monitoring. Study findings will inform clinical practice in treating pediatric severe TBI globally. Focused didactic and experience-based learning opportunities will increase the research capacity of pediatric intensivists in Latin America.",[265],"Severe Traumatic Brain Injury",[267,268,269,270,271,272,273],"sTBI","ICP monitoring","randomized controlled trial","TBI management","Latin America","pediatric","Phase III","2025-06-25",{"date":276,"type":277},"2025-06-27","ACTUAL",{"date":279,"type":277},"2023-03-22",{"date":281,"type":259},"2028-01-31",{"name":5,"class":6},11]