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.
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)
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.
Parallel
ICP
Other interventionThe intervention is a management protocol that includes ICP monitoring for children with severe traumatic brain injury
CREVICE
Other interventionThe intervention is a management protocol that is based on imaging and clinical examinations without ICP monitoring for children with severe traumatic brain injury
Pediatric Quality of Life Inventory (PedsQL)
PedsQL is a generic, health-related quality of life instrument developed to measure the core dimensions of physical, cognitive, mental, social health, and role (school) function. Minimum and maximum values: 0-100. Higher scores have better outcomes.
Pediatric Quality of Life Inventory (PedsQL)
PedsQL is a generic, health-related quality of life instrument developed to measure the core dimensions of physical, cognitive, mental, social health, and role (school) function. Minimum and maximum values: 0 - 100. Higher the score means a better outcome.
Glasgow Outcome Scale - Extended (GOS-E) Pediatric
GOS-E is the most common measure of functional outcome in adult TBI trials. Its pediatric version is the primary outcome in the NINDS-funded ADAPT study. Minimum and maximum values: 1-8. Higher score has worse outcomes.
Mortality
Percent of participants who have died by the assessment time.
Brain-specific interventions
Total number of individual interventions directed at treating measured or suspected intracranial hypertension (i.e., brain-specific treatment) per hour summed over the duration of brain-specific treatment in ICU. Time Frame for brain-specific treatments is through acute hospitalization, an average of one (1) month and for GOS-E Peds is conducted 3 and 6 months after injury.
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator