Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics (BELA TRIPP)

June 25, 2025 updated by: Randall M. Chesnut, University of Washington

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

428

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Randall M Chesnut, MD
  • Phone Number: 2067449322
  • Email: chesnutr@uw.edu

Study Contact Backup

  • Name: Kelley Chaddock, BA
  • Phone Number: 2067449322
  • Email: chaddk@uw.edu

Study Locations

  • Colombia
      • Bogota, Colombia
        • Recruiting
        • Fundación Hospital de la Misericordia
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Orlando Faber Rincón, MD
      • Monteria, Colombia
        • Recruiting
        • Hospital Fundacion Amigos de la Salud
        • Contact:
        • Sub-Investigator:
          • Antonio Macareno Atencia, MD
        • Sub-Investigator:
          • Washington WP Cardenas, MD
  • El Salvador
      • San Salvador, El Salvador
  • Guatemala
      • Escuintla, Guatemala
      • Guatemala City, Guatemala
      • Quetzaltenango, Guatemala
  • Honduras
  • Peru
  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • Not yet recruiting
        • University of Washington, Harborview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ICP monitoring based Protocol
Arm one will use a consensus-developed management protocol for paediatric severe traumatic brain injury based on recommendations from the Brain Trauma Foundation Guidelines, which uses invasive intracranial pressure monitoring
Other: ICP
The intervention is a management protocol that includes ICP monitoring for children with severe traumatic brain injury
Other Names:
  • Intracranial-pressure-monitoring-based management protocol
Active Comparator: No ICP Monitoring Protocol CREVICE
Arm two will use the Consensus-Revised Imaging and Clinical Examination (CREVICE) management protocol for paediatric severe traumatic brain injury based on imaging and clinical examination in the absence of invasive intracranial pressure monitoring
Other: 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
Other Names:
  • Imaging-and-clinical-examination-based management protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Quality of Life Inventory (PedsQL)
Time Frame: 6 months after injury
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Quality of Life Inventory (PedsQL)
Time Frame: 3 months after injury
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
Glasgow Outcome Scale - Extended (GOS-E) Pediatric
Time Frame: 3 and 6 months after injury
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
Mortality
Time Frame: 3 and 6 months
Percent of participants who have died by the assessment time.
3 and 6 months
Brain-specific interventions
Time Frame: 1 month average
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
ICU length of stay
Time Frame: 1 month average
ICU length of stay related to TBI management is through acute hospitalization and for an average of one (1) month.
1 month average

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Randall Chesnut, MD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2023

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

June 10, 2022

First Submitted That Met QC Criteria

October 1, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Actual)

June 27, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00013122
  • 1R01HD106273-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

When the study is completed, access to study data may be provided through the UW Data Repository for future analyses about brain injury, its treatment, and outcomes or other scientifically appropriate questions. A de-identified dataset will be provided to successful candidates for the specified use.

IPD Sharing Time Frame

Data will be made available 1 year after the primary study results are published.

IPD Sharing Access Criteria

Researchers will complete a data use agreement that includes the questions to be answered with the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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