About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ICP
- CREVICE
Treatment groups
Sponsors and collaborators
University of Washington
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator