Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics
NCT ID: NCT05566431
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
428 participants
INTERVENTIONAL
2023-03-22
2028-01-31
Brief Summary
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Worldwide, 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.
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Detailed Description
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Children who survive severe traumatic brain injury (sTBI) live with profound impairments that alter their development and future possibilities. Worldwide, TBI is the leading cause of death and disability for children/ adolescents with the US annual incidence 6 times greater than MS, HIV/AIDS, spinal cord injury, and breast cancer combined.
Our primary focus for scientific investigation is to conduct a high quality randomized controlled trial addressing a critical TBI management question: Does using a protocol with information from intracranial pressure (ICP) monitoring to direct treatment of children with sTBI improve outcomes vs an aggressive management protocol based on imaging and clinical examination alone? This follows on our adult ICP study which found no outcome differences and has occasioned re-thinking of treatment guidelines for sTBI patients \>13. A separate study is essential because children are not simply small adults and some treatment approaches carry age-related additional risks. Thus, study findings will inform US and global clinical practice.
This trial will be conducted in 8 Latin American pediatric ICUs where infrastructures and practice patterns are optimal for strong internal validity and resources represent trauma care in the developing world. The successful adolescent/adult BEST TRIP trial, which collected high-quality data in similar environments (cited \> 900 times) underscores the feasibility of this approach.
Specific Aim: In a Phase III randomized superiority trial in 428 children with sTBI from 8 Latin American pediatric trauma centers, test the effect on outcomes of management of sTBI guided by a protocol using information from ICP monitors vs. management using a protocol that uses imaging and clinical exams to guide treatment.
Hypothesis #1: Children with severe TBI whose acute care treatment is managed using a protocol based on data from ICP monitoring will have significantly lower mortality and better quality of life and global outcome at 6 months post-trauma than those whose treatment is managed with a protocol based on imaging and clinical exam. The primary measure of functional recovery is the PedsQL at 6 months. A secondary measure is GOSE-Peds.
Hypothesis #2: Incorporating ICP monitoring into sTBI patient care will minimize secondary complications, decrease length of stay in ICU and decrease brain-specific treatments.
Specific Aim: The Investigators will train personnel in centers new to research how to conduct high-quality scientific studies, and will extend the training for the personnel with whom the Investigators have been working, solidifying previous capacity-building efforts, and initiating new efforts.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ICP monitoring based Protocol
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
ICP
The intervention is a management protocol that includes ICP monitoring for children with severe traumatic brain injury
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
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
Interventions
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ICP
The intervention is a management protocol that includes ICP monitoring for children with severe traumatic brain injury
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Non-penetrating TBI
3. Admission to study hospital within 24 hours of injury
4. Total GCS score ≤ 8 on admission or within first 48 hours after injury (measured using pediatric GCS 1 for children \< 2 years old and standard GCS for older children)
5. Age 1 through 12 years
6. Able to randomize:
* Within 24 hours of injury (for patients with GCS ≤ 8 on admission) OR
* Within 24 hours of deterioration (for patients deteriorating to GCS ≤ 8 within 48 hours of injury)
Exclusion Criteria
2. GCS of 3 with bilaterally fixed and dilated pupils
3. Injury thought to be intentionally inflicted by a family member or caregiver.
1 Year
12 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Washington
OTHER
Responsible Party
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Randall M. Chesnut
Professor, School of Medicine
Principal Investigators
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Randall Chesnut, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington, Harborview Medical Center
Seattle, Washington, United States
Fundación Hospital de la Misericordia
Bogotá, , Colombia
Hospital Fundacion Amigos de la Salud
Montería, , Colombia
Hospital de Niños Benjamín Bloom
San Salvador, , El Salvador
Hospital Regional de Esquintla
Escuintla, , Guatemala
Hospital General San Juan de Dios
Guatemala City, , Guatemala
Hospital Regional de Occidente San Juan de Dios
Quetzaltenango, , Guatemala
Hospital Escuela
Tegucigalpa, , Honduras
Hospital de Emergencias Pediátricas
Lima, , Peru
Hospital Edgardo Rebagliati Martins
Lima, , Peru
Instituto Nacional de Salud del Niño - San Borja
Lima, , Peru
Countries
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Central Contacts
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Facility Contacts
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References
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Chesnut R, Temkin N, Pridgeon J, Sulzbacher S, Lujan S, Videtta W, Moya-Barquin L, Chaddock K, Bonow RH, Petroni G, Guadagnoli N, Hendrickson P, Ramirez Cortez G, Carreazo NY, Vargas Aymituma A, Anchante D, Caqui P, Ramirez A, Munaico Abanto M, Ortiz Chicchon M, Cenzano Ramos J, Castro Darce MDC, Sierra Morales R, Brol Lopez P, Menendez W, Posadas Gutierrez S, Kevin V, Mazariegos A, de Leon E, Rodas Barrios RE, Rodriguez S, Flores S, Alvarado O, Guzman Flores LJ, Moisa Martinez M, Gonzalez P. Development of a Randomized Trial Comparing ICP-Monitor-Based Management of Severe Pediatric Traumatic Brain Injury to Management Based on Imaging and Clinical Examination Without ICP Monitoring-Research Algorithms. Neurosurgery. 2024 Jan 1;94(1):72-79. doi: 10.1227/neu.0000000000002760. Epub 2023 Nov 13.
Chesnut R, Temkin N, Pridgeon J, Sulzbacher S, Lujan S, Videtta W, Moya-Barquin L, Chaddock K, Bonow R, Petroni G, Guadagnoli N, Hendrickson P, Ramirez Cortez G, Carreazo NY, Vargas Aymituma A, Anchante D, Caqui P, Ramirez A, Munaico Abanto M, Ortiz Chicchon M, Cenzano Ramos J, Mazate-Mazariegos A, Castro Darce MDC, Sierra Morales R, Brol Lopez P, Menendez W, Posadas Gutierrez S, Kevin V, Mazariegos A, de Leon E, Rodas Barrios RE, Rodriguez S, Flores S, Alvarado O, Guzman Flores LJ, Moisa Martinez M, Gonzalez P. Development of a Randomized Trial Comparing ICP-Monitor-Based Management of Severe Pediatric Traumatic Brain Injury to Management Based on Imaging and Clinical Examination Without ICP Monitoring-Study Protocol. Neurosurgery. 2024 Jan 1;94(1):65-71. doi: 10.1227/neu.0000000000002582. Epub 2023 Jul 6.
Other Identifiers
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STUDY00013122
Identifier Type: -
Identifier Source: org_study_id
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