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

Severe Traumatic Brain Injury Clinical Trial

— BELA TRIPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05566431
• Other study ID #: STUDY00013122
• Secondary ID: 1R01HD106273-01
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: December 2023
• Source: University of Washington
• Contact: Randall M Chesnut, MD
• Phone: 2067449322
• Email: chesnutr[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Abstract: Children who survive severe traumatic brain injury (sTBI) live with profound impairments that alter their development and future possibilities. Worldwide, TBI is the leading cause of death and disability for children/ adolescents with the US annual incidence 6 times greater than MS, HIV/AIDS, spinal cord injury, and breast cancer combined. Our primary focus for scientific investigation is to conduct a high quality randomized controlled trial addressing a critical TBI management question: Does using a protocol with information from intracranial pressure (ICP) monitoring to direct treatment of children with sTBI improve outcomes vs an aggressive management protocol based on imaging and clinical examination alone? This follows on our adult ICP study which found no outcome differences and has occasioned re-thinking of treatment guidelines for sTBI patients >13. A separate study is essential because children are not simply small adults and some treatment approaches carry age-related additional risks. Thus, study findings will inform US and global clinical practice. This trial will be conducted in 8 Latin American pediatric ICUs where infrastructures and practice patterns are optimal for strong internal validity and resources represent trauma care in the developing world. The successful adolescent/adult BEST TRIP trial, which collected high-quality data in similar environments (cited > 900 times) underscores the feasibility of this approach. Specific Aim: In a Phase III randomized superiority trial in 428 children with sTBI from 8 Latin American pediatric trauma centers, test the effect on outcomes of management of sTBI guided by a protocol using information from ICP monitors vs. management using a protocol that uses imaging and clinical exams to guide treatment. Hypothesis #1: Children with severe TBI whose acute care treatment is managed using a protocol based on data from ICP monitoring will have significantly lower mortality and better quality of life and global outcome at 6 months post-trauma than those whose treatment is managed with a protocol based on imaging and clinical exam. The primary measure of functional recovery is the PedsQL at 6 months. A secondary measure is GOSE-Peds. Hypothesis #2: Incorporating ICP monitoring into sTBI patient care will minimize secondary complications, decrease length of stay in ICU and decrease brain-specific treatments. Specific Aim: The Investigators will train personnel in centers new to research how to conduct high-quality scientific studies, and will extend the training for the personnel with whom the Investigators have been working, solidifying previous capacity-building efforts, and initiating new efforts.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 428
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Severe Traumatic Brain Injury

Intervention

Other:
• ICP
The intervention is a management protocol that includes ICP monitoring for children with severe traumatic brain injury
• CREVICE
The intervention is a management protocol that is based on imaging and clinical examinations without ICP monitoring for children with severe traumatic brain injury

Locations

Country	Name	City	State
El Salvador	Hospital de Niños Benjamín Bloom	San Salvador
Guatemala	Hospital Regional de Esquintla	Escuintla
Guatemala	Hospital General San Juan de Dios	Guatemala City
Guatemala	Hospital Regional de Occidente San Juan de Dios	Quetzaltenango
Honduras	Hospital Escuela	Tegucigalpa
Peru	Hospital de Emergencias Pediátricas	Lima
Peru	Hospital Edgardo Rebagliati Martins	Lima
Peru	Instituto Nacional de Salud del Niño - San Borja	Lima
United States	University of Washington, Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  El Salvador,  Guatemala,  Honduras,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pediatric Quality of Life Inventory (PedsQL)	PedsQL is a generic, health-related quality of life instrument developed to measure the core dimensions of physical, cognitive, mental, social health, and role (school) function. Minimum and maximum values: 0-100. Higher scores have better outcomes.	6 months after injury
Secondary	Pediatric Quality of Life Inventory (PedsQL)	PedsQL is a generic, health-related quality of life instrument developed to measure the core dimensions of physical, cognitive, mental, social health, and role (school) function. Minimum and maximum values: 0 - 100. Higher the score means a better outcome.	3 months after injury
Secondary	Glasgow Outcome Scale - Extended (GOS-E) Pediatric	GOS-E is the most common measure of functional outcome in adult TBI trials. Its pediatric version is the primary outcome in the NINDS-funded ADAPT study. Minimum and maximum values: 1-8. Higher score has worse outcomes.	3 and 6 months after injury
Secondary	Mortality	Percent of participants who have died by the assessment time.	3 and 6 months
Secondary	Brain-specific interventions	Total number of individual interventions directed at treating measured or suspected intracranial hypertension (i.e., brain-specific treatment) per hour summed over the duration of brain-specific treatment in ICU. Time Frame for brain-specific treatments is through acute hospitalization, an average of one (1) month and for GOS-E Peds is conducted 3 and 6 months after injury.	1 month average
Secondary	ICU length of stay	ICU length of stay related to TBI management is through acute hospitalization and for an average of one (1) month.	1 month average