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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

Who can join

Ages 1 to 12 · All sexes

Inclusion Criteria:

1. Provision of signed and dated informed consent form by the parent(s) or guardian(s)
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:

1. Motor GCS score of 6
2. GCS of 3 with bilaterally fixed and dilated pupils
3. Injury thought to be intentionally inflicted by a family member or caregiver.

About the study

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.

What is being tested

• ICP (other)
• CREVICE (other)

Sponsor: University of Washington · Participants: 428 · Started: Mar 22, 2023

Contact the study team

• Randall M Chesnut, MD · Phone: 2067449322
• Kelley Chaddock, BA · Phone: 2067449322

Official record on ClinicalTrials.gov — NCT05566431

Locations in the U.S.

Conditions

• Traumatic Brain Injury

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.