Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT05566431
Status
Recruiting
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Conditions

  • Severe Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
1 Year - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • ICP — OTHER
    The intervention is a management protocol that includes ICP monitoring for children with severe traumatic brain injury
  • CREVICE — OTHER
    The intervention is a management protocol that is based on imaging and clinical examinations without ICP monitoring for children with severe traumatic brain injury

Study Details

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.

Key Dates

Start date
Mar 22, 2023
Status verified
Jun 2025
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
428 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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
  • Active Comparator: 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

Primary Outcome Measure

Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: 6 months after injury ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Washington, Harborview Medical CenterSeattleWashington98104-

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By research site
University of Washington, Harborview Medical Center· Seattle, WA

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