Actively Recruiting
Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics
Led by University of Washington · Updated on 2025-06-27
428
Participants Needed
11
Research Sites
253 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent from parent(s) or guardian(s)
- Non-penetrating traumatic brain injury
- Admission to study hospital within 24 hours of injury
- Glasgow Coma Scale (GCS) score 8 or less on admission or within 48 hours after injury (using pediatric GCS for children under 2 years)
- Age between 1 and 12 years
- Able to randomize within 24 hours of injury or deterioration to GCS 8 or less within 48 hours
You will not qualify if you...
- Motor GCS score of 6
- GCS of 3 with bilaterally fixed and dilated pupils
- Injury suspected to be intentionally caused by a family member or caregiver
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
University of Washington, Harborview Medical Center
Seattle, Washington, United States, 98104
Not Yet Recruiting
2
Fundación Hospital de la Misericordia
Bogotá, Colombia
Actively Recruiting
3
Hospital Fundacion Amigos de la Salud
Montería, Colombia
Actively Recruiting
4
Hospital de Niños Benjamín Bloom
San Salvador, El Salvador
Actively Recruiting
5
Hospital Regional de Esquintla
Escuintla, Guatemala
Actively Recruiting
6
Hospital General San Juan de Dios
Guatemala City, Guatemala
Actively Recruiting
7
Hospital Regional de Occidente San Juan de Dios
Quetzaltenango, Guatemala
Actively Recruiting
8
Hospital Escuela
Tegucigalpa, Honduras
Actively Recruiting
9
Hospital de Emergencias Pediátricas
Lima, Peru
Actively Recruiting
10
Hospital Edgardo Rebagliati Martins
Lima, Peru
Actively Recruiting
11
Instituto Nacional de Salud del Niño - San Borja
Lima, Peru
Actively Recruiting
Research Team
R
Randall M Chesnut, MD
CONTACT
K
Kelley Chaddock, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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