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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-12
SponsorUniversity of Washington

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

428 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Washington

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator