Severe Traumatic Brain InjuryBELA TRIPPNCT05566431
Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics
A study testing ICP and CREVICE in people with Severe Traumatic Brain Injury, run by University of Washington at 11 sites in 6 countries.
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… Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Severe Traumatic Brain Injury
- What is being tested?
- ICP and CREVICE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 11 sitesin 6 countries
- Study dates
- 22 Mar 2023to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
11 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 6 countries
Guatemala3 sites, 3 recruiting
- Recruiting
Hospital Regional de Esquintla
Escuintla
Willy Menendez, MD, +502 5204 4531, menendezwilly@yahoo.com.mx
Sophia Posadas, MD, +502 4063 0100, Sofia_posadas@yahoo.com
- Recruiting
Hospital General San Juan de Dios
Guatemala City
Maria del Carmen Castro, MD, +502 4255 2860, carmencd85@gmail.com
Roberto Sierra, MD, +502 5439 8462, robertsierramorales@gmail.com
- Recruiting
Hospital Regional de Occidente San Juan de Dios
Quetzaltenango
Andrea Mazariegos, MD, 502 4154 9866, andre_mazar3@hotmail.com
Elie de Leon, MD, + 502 50188332, elieneurology28@gmail.com
Peru3 sites, 3 recruiting
- Recruiting
Hospital de Emergencias Pediátricas
Lima
Grimaldo C Ramirez, MD, +51 997 294 904, gramirezcortez61@gmail.com
Yhuri Carreazo, MD, +51 997252543, yhuroc@gmail.com
- Recruiting
Hospital Edgardo Rebagliati Martins
Lima
Manuel Munaico, MD, 51948418590, munakusqayku@gmail.com
Manuel Ortiz, MD, 51987817613, manortizch@hotmail.com
- Recruiting
Instituto Nacional de Salud del Niño - San Borja
Lima
Daniel Achante, MD, 51961090970, danielanchante@hotmail.com
Patrick Caqui, MD, 51933160526, patrickdannycaquivilca@gmail.com
Colombia2 sites, 2 recruiting
- Recruiting
Fundación Hospital de la Misericordia
Bogotá
Juan David Roa Giraldo, MD, 3013380506, Jdroag@gmail.com
Wenci Camilo Navarro, MD, 3004576234, Camilosuescun18@gmail.com
- Recruiting
Hospital Fundacion Amigos de la Salud
Montería
Yojana Nova, MD, 57 3245819372, yonova12@gmail.com
Antonio Macareno Atencia, MD
United States1 site, 1 recruiting
- Not yet recruiting
University of Washington, Harborview Medical Center
Seattle, Washington, 98104
El Salvador1 site, 1 recruiting
- Recruiting
Hospital de Niños Benjamín Bloom
San Salvador
Luis J Guzman, MD, 503 7318 4077, licoguzman@yahoo.com.mx
Melvin Moisa, MD, +503 7160 2879, melvin3_29@hotmail.com
Honduras1 site, 1 recruiting
- Recruiting
Hospital Escuela
Tegucigalpa
Sandra Rodriguez, MD, 50499983875, sandra.rodriguez@unah.edu.hn
Sandra Flores, MD, 50499077099, floresirias@yahoo.es
About this study
Official title: 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.
Read the 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.
- Conditions
- Severe Traumatic Brain Injury
- Being tested
- ICP, CREVICE
- Keywords
- sTBI, ICP monitoring, randomized controlled trial, TBI management, Latin America, pediatric, Phase III
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICPOther
Also called Intracranial-pressure-monitoring-based management protocol
The intervention is a management protocol that includes ICP monitoring for children with severe traumatic brain injury
CREVICEOther
Also called Imaging-and-clinical-examination-based management protocol
The intervention is a management protocol that is based on imaging and clinical examinations without ICP monitoring for children with severe traumatic brain injury
| Study group | Role | What they receive |
|---|---|---|
| ICP monitoring based Protocol | Active comparator | 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 Receives: Other: ICP |
| No ICP Monitoring Protocol CREVICE | Active comparator | 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 Receives: Other: CREVICE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after injury
Secondary outcomes (5)
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.
Measured: 3 months after injury
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.
Measured: 3 and 6 months after injury
Mortality
Percent of participants who have died by the assessment time.
Measured: 3 and 6 months
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.
Measured: 1 month average
ICU length of stay
ICU length of stay related to TBI management is through acute hospitalization and for an average of one (1) month.
Measured: 1 month average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start22 Mar 2023
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Randall M. Chesnut, University of Washington
- Investigators
- Randall Chesnut, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566431
- Sponsor's protocol ID
- STUDY00013122
- Other IDs
- 1R01HD106273-01
- Acronym
- BELA TRIPP
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2022
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Chesnut R, Temkin N, Pridgeon J, Sulzbacher S, Lujan S, Videtta W, Moya-Barquin L, Chaddock K, Bonow RH, Petroni G, Guadagnoli N, Hendrickson P, Ramirez Cortez G, Carreazo NY, Vargas Aymituma A, Anchante D, Caqui P, Ramirez A, Munaico Abanto M, Ortiz Chicchon M, Cenzano Ramos J, Castro Darce MDC, Sierra Morales R, Brol Lopez P, Menendez W, Posadas Gutierrez S, Kevin V, Mazariegos A, de Leon E, Rodas Barrios RE, Rodriguez S, Flores S, Alvarado O, Guzman Flores LJ, Moisa Martinez M, Gonzalez P. Development of a Randomized Trial Comparing ICP-Monitor-Based Management of Severe Pediatric Traumatic Brain Injury to Management Based on Imaging and Clinical Examination Without ICP Monitoring-Research Algorithms. Neurosurgery. 2024 Jan 1;94(1):72-79. doi: 10.1227/neu.0000000000002760. Epub 2023 Nov 13.
PubMed 37955439Chesnut R, Temkin N, Pridgeon J, Sulzbacher S, Lujan S, Videtta W, Moya-Barquin L, Chaddock K, Bonow R, Petroni G, Guadagnoli N, Hendrickson P, Ramirez Cortez G, Carreazo NY, Vargas Aymituma A, Anchante D, Caqui P, Ramirez A, Munaico Abanto M, Ortiz Chicchon M, Cenzano Ramos J, Mazate-Mazariegos A, Castro Darce MDC, Sierra Morales R, Brol Lopez P, Menendez W, Posadas Gutierrez S, Kevin V, Mazariegos A, de Leon E, Rodas Barrios RE, Rodriguez S, Flores S, Alvarado O, Guzman Flores LJ, Moisa Martinez M, Gonzalez P. Development of a Randomized Trial Comparing ICP-Monitor-Based Management of Severe Pediatric Traumatic Brain Injury to Management Based on Imaging and Clinical Examination Without ICP Monitoring-Study Protocol. Neurosurgery. 2024 Jan 1;94(1):65-71. doi: 10.1227/neu.0000000000002582. Epub 2023 Jul 6.
PubMed 37409817
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Severe Traumatic Brain Injury in Latin America - A Randomized Trial Comparing Two Management Protocols
- ClinicalTrials.gov ID
- NCT05566431
- Acronym / sponsor ID
- BELA TRIPP / STUDY00013122
- Conditions
- Severe Traumatic Brain Injury
- Keywords
- sTBI, ICP monitoring, randomized controlled trial, TBI management, Latin America, pediatric, Phase III
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ICP monitoring based Protocol | Active comparator | Other: ICPArm 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 |
| No ICP Monitoring Protocol CREVICE | Active comparator | Other: CREVICEArm 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 |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICPAlso: Intracranial-pressure-monitoring-based management protocolThe intervention is a management protocol that includes ICP monitoring for children with severe traumatic brain injury | Other | ICP monitoring based Protocol |
| CREVICEAlso: Imaging-and-clinical-examination-based management protocolThe intervention is a management protocol that is based on imaging and clinical examinations without ICP monitoring for children with severe traumatic brain injury | Other | No ICP Monitoring Protocol CREVICE |
Primary outcome
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.
5 secondary outcomes
Pediatric Quality of Life Inventory (PedsQL)
Time frame: 3 months after injury
Glasgow Outcome Scale - Extended (GOS-E) Pediatric
Time frame: 3 and 6 months after injury
Mortality
Time frame: 3 and 6 months
Brain-specific interventions
Time frame: 1 month average
ICU length of stay
Time frame: 1 month average
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Derived from this study: PubMed 37955439Chesnut R, Temkin N, Pridgeon J, Sulzbacher S, Lujan S, Videtta W, Moya-Barquin L, Chaddock K, Bonow RH, Petroni G, Guadagnoli N, Hendrickson P, Ramirez Cortez G, Carreazo NY, Vargas Aymituma A, Anchante D, Caqui P, Ramirez A, Munaico Abanto M, Ortiz Chicchon M, Cenzano Ramos J, Castro Darce MDC, Sierra Morales R, Brol Lopez P, Menendez W, Posadas Gutierrez S, Kevin V, Mazariegos A, de Leon E, Rodas Barrios RE, Rodriguez S, Flores S, Alvarado O, Guzman Flores LJ, Moisa Martinez M, Gonzalez P. Development of a Randomized Trial Comparing ICP-Monitor-Based Management of Severe Pediatric Traumatic Brain Injury to Management Based on Imaging and Clinical Examination Without ICP Monitoring-Research Algorithms. Neurosurgery. 2024 Jan 1;94(1):72-79. doi: 10.1227/neu.0000000000002760. Epub 2023 Nov 13.
- Derived from this study: PubMed 37409817Chesnut R, Temkin N, Pridgeon J, Sulzbacher S, Lujan S, Videtta W, Moya-Barquin L, Chaddock K, Bonow R, Petroni G, Guadagnoli N, Hendrickson P, Ramirez Cortez G, Carreazo NY, Vargas Aymituma A, Anchante D, Caqui P, Ramirez A, Munaico Abanto M, Ortiz Chicchon M, Cenzano Ramos J, Mazate-Mazariegos A, Castro Darce MDC, Sierra Morales R, Brol Lopez P, Menendez W, Posadas Gutierrez S, Kevin V, Mazariegos A, de Leon E, Rodas Barrios RE, Rodriguez S, Flores S, Alvarado O, Guzman Flores LJ, Moisa Martinez M, Gonzalez P. Development of a Randomized Trial Comparing ICP-Monitor-Based Management of Severe Pediatric Traumatic Brain Injury to Management Based on Imaging and Clinical Examination Without ICP Monitoring-Study Protocol. Neurosurgery. 2024 Jan 1;94(1):65-71. doi: 10.1227/neu.0000000000002582. Epub 2023 Jul 6.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Randall Chesnut, MD principal investigator
University of Washington
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICP and CREVICE in people with Severe Traumatic Brain Injury, run by University of Washington at 11 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Guatemala, Peru, Colombia, United States, El Salvador and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Randall M Chesnut, MD (2067449322, chesnutr@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Quality of Life Inventory (PedsQL) (time frame: 6 months after injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05566431, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.