Pediatric Severe Traumatic Brain Injury in Latin America - A Randomized Trial Comparing Two Management Protocols
University of Washington
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.
Description
Abstract: Children who survive severe traumatic brain injury (sTBI) live with profound impairments that alter their development and future possibilities. Worldwide, TBI is the leading cause of death and disability for children/ adolescents with the US annual incidence 6 times greater than MS, HIV/AIDS, spinal cord injury, and breast cancer combined. Our primary focus for scientific investigation is to conduct a high quality randomized controlled trial addressing a critical TBI management question: Does using a protocol with information from intracranial pressure (ICP) monitoring to direct tr…
Eligibility
- Age range
- 1–12 years
- Sex
- All
- Healthy volunteers
- No
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 Cr…
Interventions
- OtherICP
The intervention is a management protocol that includes ICP monitoring for children with severe traumatic brain injury
- OtherCREVICE
The intervention is a management protocol that is based on imaging and clinical examinations without ICP monitoring for children with severe traumatic brain injury
Locations (11)
- University of Washington, Harborview Medical CenterSeattle, Washington
- Fundación Hospital de la MisericordiaBogotá
- Hospital Fundacion Amigos de la SaludMontería
- Hospital de Niños Benjamín BloomSan Salvador
- Hospital Regional de EsquintlaEscuintla
- Hospital General San Juan de DiosGuatemala City