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New treatment option for Severe Traumatic Brain Injury
Official title Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics
ClinicalTrials.gov ID: NCT05566431
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 12
You may be able to join if
- 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...
- Age 1 through 12 years
You likely can't join if
- 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.
See the full eligibility 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:
- 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)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
- Bogotá, Colombia
- Montería, Colombia
- San Salvador, El Salvador
- Escuintla, Guatemala
- Guatemala City, Guatemala
- Quetzaltenango, Guatemala
- Tegucigalpa, Honduras
- Lima, Peru
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States; Bogotá, Colombia; Montería, Colombia; San Salvador, El Salvador; Escuintla, Guatemala; Guatemala City, Guatemala and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.