Trial of Intracranial Pressure Monitoring in Pediatric Severe Traumatic Brain Injury

Pediatric Severe Traumatic Brain Injury in Latin America - A Randomized Trial Comparing Two Management Protocols

This study tests if using a special monitor to check brain pressure helps children with severe brain injuries recover better than just relying on scans and exams.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 428 (estimated)
• Ages: 1 Year to 12 Years
• Sex: All
• Sponsor: University of Washington (Academic / other)
• Locations: 11 sites (Seattle, Washington and 10 other locations)
• Trial ID: NCT05566431 on ClinicalTrials.gov

What this trial studies

This trial investigates whether treatment for severe traumatic brain injury (sTBI) in children, guided by invasive intracranial pressure (ICP) monitoring, leads to better outcomes compared to treatment based solely on imaging and clinical examination. Conducted in eight pediatric ICUs across Latin America, the study aims to enhance clinical practices and research capacity in the region. The trial will involve randomizing eligible patients within 24 hours of injury or deterioration, focusing on those aged 1 to 12 years with a Glasgow Coma Scale (GCS) score of 8 or less. Findings from this trial are expected to inform global treatment guidelines for pediatric TBI.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 1 to 12 years who have experienced a non-penetrating traumatic brain injury and have a GCS score of 8 or less.

Not a fit: Patients with a motor GCS score of 6 or those with a GCS of 3 and bilaterally fixed and dilated pupils may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve treatment outcomes for children suffering from severe traumatic brain injuries.

How similar studies have performed: Previous studies, such as the adult BEST TRIP trial, have shown success in similar environments, indicating the feasibility of this approach.

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.

Where this trial is running

Seattle, Washington and 10 other locations

• University of Washington, Harborview Medical Center — Seattle, Washington, United States (Not_yet_recruiting)
• Fundación Hospital de la Misericordia — Bogotá, Colombia (Recruiting)
• Hospital Fundacion Amigos de la Salud — Montería, Colombia (Recruiting)
• Hospital de Niños Benjamín Bloom — San Salvador, El Salvador (Recruiting)
• Hospital Regional de Esquintla — Escuintla, Guatemala (Recruiting)
• Hospital General San Juan de Dios — Guatemala City, Guatemala (Recruiting)
• Hospital Regional de Occidente San Juan de Dios — Quetzaltenango, Guatemala (Recruiting)
• Hospital Escuela — Tegucigalpa, Honduras (Recruiting)
• Hospital de Emergencias Pediátricas — Lima, Peru (Recruiting)
• Hospital Edgardo Rebagliati Martins — Lima, Peru (Recruiting)
• Instituto Nacional de Salud del Niño - San Borja — Lima, Peru (Recruiting)

Study contacts

• Principal investigator: Randall Chesnut, MD — University of Washington
• Study coordinator: Randall M Chesnut, MD

Conditions Severe Traumatic Brain Injury; sTBI; ICP monitoring; randomized controlled trial; TBI management; Latin America; pediatric; Phase III