RecruitingNot Applicable

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

United States, Colombia, El Salvador428 participantsStarted 2023-03-22

Plain-language 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.

Who can participate

Age range1 Year – 12 Years

SexALL

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Inclusion criteria

✓. 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)
✓. Age 1 through 12 years
✓. Able to randomize:

Exclusion criteria

✕. 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.

What they're measuring

Pediatric Quality of Life Inventory (PedsQL)

Timeframe: 6 months after injury

Trial details

NCT IDNCT05566431

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-31

Contact for this trial

Randall M Chesnut, MD

2067449322 chesnutr@uw.edu

View on ClinicalTrials.gov More Severe Traumatic Brain Injury trials