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

RecruitingNAAges 1 Year - 12 YearsAllUniversity of Washington
NCT05566431 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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.
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What it tests

  • ICP
  • CREVICE
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Where

11 sites
University of Washington, Harborview Medical Center
Seattle, 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

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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