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Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics (BELLA TRIP-P)

Primary Purpose

Severe Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ICP
CREVICE
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Traumatic Brain Injury focused on measuring sTBI, ICP monitoring, randomized controlled trial, TBI management, Latin America, pediatric, Phase III

Eligibility Criteria

1 Year - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Washington, Harborview Medical Center
  • Hospital de Niños Benjamín BloomRecruiting
  • Hospital Regional de EsquintlaRecruiting
  • Hospital General San Juan de DiosRecruiting
  • Hospital Regional de Occidente San Juan de DiosRecruiting
  • Hospital EscuelaRecruiting
  • Hospital de Emergencias PediátricasRecruiting
  • Hospital Edgardo Rebagliati MartinsRecruiting
  • Instituto Nacional de Salud del Niño - San BorjaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ICP monitoring based Protocol

No ICP Monitoring Protocol CREVICE

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Mortality
Percent of participants who have died by the assessment time.
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.
ICU length of stay
ICU length of stay related to TBI management is through acute hospitalization and for an average of one (1) month.

Full Information

First Posted
June 10, 2022
Last Updated
May 17, 2023
Sponsor
University of Washington
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05566431
Brief Title
Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics
Acronym
BELLA TRIP-P
Official Title
Pediatric Severe Traumatic Brain Injury in Latin America - A Randomized Trial Comparing Two Management Protocols
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2023 (Actual)
Primary Completion Date
July 31, 2026 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Traumatic Brain Injury
Keywords
sTBI, ICP monitoring, randomized controlled trial, TBI management, Latin America, pediatric, Phase III

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In a Phase III multicenter, parallel-group, randomized superiority trial in 428 children with sTBI from 7 Latin American pediatric trauma centers, the objective is to test the efficacy of the treatment protocol from the Guidelines based on ICP monitoring among children with sTBI in improving global outcome measured by Pediatric Quality of Life Inventory (PedsQL) 6 mos after injury compared to treatment based on a non-invasive imaging & clinical examination (CREVICE) protocol specifically modified for a pediatric population.
Masking
Outcomes Assessor
Masking Description
Outcome assessors will not go into the ICU when a study participant is being treated, unmasked study staff will not inform the outcome assessor which protocol was used for a participant. and outcome assessors will remind participant's parents to refrain for telling them which treatment protocol was used for the participant.
Allocation
Randomized
Enrollment
428 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICP monitoring based Protocol
Arm Type
Active Comparator
Arm Description
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
Arm Title
No ICP Monitoring Protocol CREVICE
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
ICP
Other Intervention Name(s)
Intracranial-pressure-monitoring-based management protocol
Intervention Description
The intervention is a management protocol that includes ICP monitoring for children with severe traumatic brain injury
Intervention Type
Other
Intervention Name(s)
CREVICE
Other Intervention Name(s)
Imaging-and-clinical-examination-based management protocol
Intervention Description
The intervention is a management protocol that is based on imaging and clinical examinations without ICP monitoring for children with severe traumatic brain injury
Primary Outcome Measure Information:
Title
Pediatric Quality of Life Inventory (PedsQL)
Description
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.
Time Frame
6 months after injury
Secondary Outcome Measure Information:
Title
Pediatric Quality of Life Inventory (PedsQL)
Description
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.
Time Frame
3 months after injury
Title
Glasgow Outcome Scale - Extended (GOS-E) Pediatric
Description
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.
Time Frame
3 and 6 months after injury
Title
Mortality
Description
Percent of participants who have died by the assessment time.
Time Frame
3 and 6 months
Title
Brain-specific interventions
Description
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.
Time Frame
1 month average
Title
ICU length of stay
Description
ICU length of stay related to TBI management is through acute hospitalization and for an average of one (1) month.
Time Frame
1 month average

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Randall M Chesnut, MD
Phone
2067449322
Email
chesnutr@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kelley Chaddock, BA
Phone
2067449322
Email
chaddk@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall Chesnut, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington, Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Hospital de Niños Benjamín Bloom
City
San Salvador
Country
El Salvador
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis J Guzman, MD
Phone
503 7318 4077
Email
licoguzman@yahoo.com.mx
First Name & Middle Initial & Last Name & Degree
Melvin Moisa, MD
Phone
+503 7160 2879
Email
melvin3_29@hotmail.com
Facility Name
Hospital Regional de Esquintla
City
Escuintla
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Willy Menendez, MD
Phone
+502 5204 4531
Email
menendezwilly@yahoo.com.mx
First Name & Middle Initial & Last Name & Degree
Sophia Posadas, MD
Phone
+502 4063 0100
Email
Sofia_posadas@yahoo.com
Facility Name
Hospital General San Juan de Dios
City
Guatemala City
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria del Carmen Castro, MD
Phone
+502 4255 2860
Email
carmencd85@gmail.com
First Name & Middle Initial & Last Name & Degree
Roberto Sierra, MD
Phone
+502 5439 8462
Email
robertsierramorales@gmail.com
Facility Name
Hospital Regional de Occidente San Juan de Dios
City
Quetzaltenango
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Mazariegos, MD
Phone
502 4154 9866
Email
andre_mazar3@hotmail.com
First Name & Middle Initial & Last Name & Degree
Elie de Leon, MD
Phone
+ 502 50188332
Email
elieneurology28@gmail.com
Facility Name
Hospital Escuela
City
Tegucigalpa
Country
Honduras
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Rodriguez, MD
Phone
50499983875
Email
sandra.rodriguez@unah.edu.hn
First Name & Middle Initial & Last Name & Degree
Sandra Flores, MD
Phone
50499077099
Email
floresirias@yahoo.es
Facility Name
Hospital de Emergencias Pediátricas
City
Lima
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grimaldo C Ramirez, MD
Phone
+51 997 294 904
Email
gramirezcortez61@gmail.com
First Name & Middle Initial & Last Name & Degree
Yhuri Carreazo, MD
Phone
+51 997252543
Email
yhuroc@gmail.com
Facility Name
Hospital Edgardo Rebagliati Martins
City
Lima
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Munaico, MD
Phone
51948418590
Email
munakusqayku@gmail.com
First Name & Middle Initial & Last Name & Degree
Manuel Ortiz, MD
Phone
51987817613
Email
manortizch@hotmail.com
Facility Name
Instituto Nacional de Salud del Niño - San Borja
City
Lima
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Achante, MD
Phone
51961090970
Email
danielanchante@hotmail.com
First Name & Middle Initial & Last Name & Degree
Patrick Caqui, MD
Phone
51933160526
Email
patrickdannycaquivilca@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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