Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics
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.
Conditions:
🦠 Severe Traumatic Brain Injury
🗓️ Study Start (Actual) 22 March 2023
🗓️ Primary Completion (Estimated) 31 December 2026
✅ Study Completion (Estimated) 31 December 2026
👥 Enrollment (Estimated) 428
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Seattle, Washington, United States
📍 San Salvador, El Salvador
📍 Escuintla, Guatemala
📍 Guatemala City, Guatemala
📍 Quetzaltenango, Guatemala
📍 Tegucigalpa, Honduras
📍 Lima, Peru
📍 Lima, Peru
📍 Lima, Peru

📋 Eligibility Criteria

Description

    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 Criteria:

    • 1. Motor GCS score of 6
    • 2. GCS of 3 with bilaterally fixed and dilated pupils
    • 3. Injury thought to be intentionally inflicted by a family member or caregiver.
Ages Eligible for Study: 1 Year to 12 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 June 2022
  • First Submitted that Met QC Criteria 1 October 2022
  • First Posted 4 October 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 June 2024
  • Last Update Posted 28 June 2024
  • Last Verified December 2023