Intracranial Pressure Monitoring for Pediatric Traumatic Brain Injury
(BELA TRIPP Trial)
Trial Summary
What is the purpose of this trial?
Narrative: 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.
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications.
What data supports the effectiveness of the treatment CREVICE, Intracranial Pressure Monitoring, ICP Monitoring, ICP, Intracranial Pressure Monitoring, ICP Monitoring for pediatric traumatic brain injury?
Is intracranial pressure monitoring safe for children with traumatic brain injury?
How does intracranial pressure monitoring differ from other treatments for pediatric traumatic brain injury?
Intracranial pressure monitoring is unique because it provides continuous, objective data on the pressure inside the skull, which is crucial for managing severe head injuries in children. Unlike other treatments that may focus on symptoms, this monitoring helps guide therapy by ensuring that interventions for other injuries do not worsen brain pressure.348910
Research Team
Randall Chesnut, MD
Principal Investigator
University of Washington
Eligibility Criteria
This trial is for children aged 1-12 who have suffered a non-penetrating traumatic brain injury (TBI) and are admitted to the hospital within 24 hours of the incident. They must have a severe TBI, indicated by a low score on the Glasgow Coma Scale (GCS), and consent from parents or guardians. Children with injuries suspected to be caused intentionally or those with certain unresponsive pupil conditions cannot participate.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive treatment for severe traumatic brain injury guided by either ICP monitoring or imaging and clinical examination protocols
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life and functional outcomes
Treatment Details
Interventions
- CREVICE (Other)
- ICP (Other)
ICP is already approved in Canada for the following indications:
- Severe Traumatic Brain Injury (TBI) in children
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Dr. Timothy H. Dellit
University of Washington
Chief Executive Officer since 2023
MD from University of Washington
Dr. Anneliese Schleyer
University of Washington
Chief Medical Officer since 2023
MD, MHA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Dr. Diana W. Bianchi
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Chief Executive Officer since 2016
MD from Stanford University
Dr. Alison Cernich
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Chief Medical Officer since 2020
PhD in Clinical Psychology from University of Maryland