NCT05566431 Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics
| NCT ID | NCT05566431 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Severe Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 428 participants |
| Start Date | 2023-03-22 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 428 participants in total. It began in 2023-03-22 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Randall Chesnut, MD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT05566431 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 12 Years, studying Severe Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05566431 currently recruiting?
Yes, NCT05566431 is actively recruiting participants. Contact the research team at chesnutr@uw.edu for enrollment information.
Where is the NCT05566431 trial being conducted?
This trial is being conducted at Seattle, United States, Bogotá, Colombia, Montería, Colombia, San Salvador, El Salvador and 7 additional locations.
Who is sponsoring the NCT05566431 clinical trial?
NCT05566431 is sponsored by University of Washington. The principal investigator is Randall Chesnut, MD at University of Washington. The trial plans to enroll 428 participants.