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

NCT05566431 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 428

Last updated 2025-06-27

No results posted yet for this study

Summary

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.

Conditions

  • Severe Traumatic Brain Injury

Interventions

OTHER

ICP

The intervention is a management protocol that includes ICP monitoring for children with severe traumatic brain injury

OTHER

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

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • Randall Chesnut, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-22
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • United States
  • Colombia
  • El Salvador
  • Guatemala
  • Honduras
  • Peru

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05566431 on ClinicalTrials.gov