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

Recruiting now · Not applicable

Conditions studied: Severe Traumatic Brain Injury

In brief

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 facts

Study ID

NCT05566431

Run by

University of Washington

People needed

428

Starts

2023-03-22

Expected to finish

2028-01-31

Last updated by the study team

2025-06-27

Who can join

Age: 1 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of signed and dated informed consent form by the parent(s) or guardian(s)
• Non-penetrating TBI
• Admission to study hospital within 24 hours of injury
• 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)
• Age 1 through 12 years
• 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)

You may not qualify if…

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

Where it is running

• Instituto Nacional de Salud del Niño - San Borja — Lima, Peru (enrolling)
• Fundación Hospital de la Misericordia — Bogotá, Colombia (enrolling)
• Hospital Fundacion Amigos de la Salud — Montería, Colombia (enrolling)
• Hospital de Niños Benjamín Bloom — San Salvador, El Salvador (enrolling)
• Hospital Regional de Esquintla — Escuintla, Guatemala (enrolling)
• Hospital General San Juan de Dios — Guatemala City, Guatemala (enrolling)
• Hospital Regional de Occidente San Juan de Dios — Quetzaltenango, Guatemala (enrolling)
• Hospital Escuela — Tegucigalpa, Honduras (enrolling)
• Hospital de Emergencias Pediátricas — Lima, Peru (enrolling)
• Hospital Edgardo Rebagliati Martins — Lima, Peru (enrolling)
• University of Washington, Harborview Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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