~190 spots leftby Dec 2026

Intracranial Pressure Monitoring for Pediatric Traumatic Brain Injury

(BELA TRIPP Trial)

Recruiting at 8 trial locations
RC
Overseen byRandall Chesnut, MD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Washington
Disqualifiers: Motor GCS score 6, GCS 3 with fixed pupils, intentional injury, others
No Placebo Group
Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the treatment CREVICE, Intracranial Pressure Monitoring, ICP Monitoring, ICP, Intracranial Pressure Monitoring, ICP Monitoring for pediatric traumatic brain injury?

Research shows that using intracranial pressure (ICP) monitoring in children with severe traumatic brain injury is linked to lower hospital mortality rates. This suggests that ICP monitoring can be an important tool in improving outcomes for these patients.12345

Is intracranial pressure monitoring safe for children with traumatic brain injury?

Intracranial pressure monitoring is commonly used in children with severe head injuries, but there are few studies specifically focused on its safety in the pediatric population. The available research suggests it is a standard part of care, but detailed safety data for children is limited.35678

How does intracranial pressure monitoring differ from other treatments for pediatric traumatic brain injury?

Intracranial pressure monitoring is unique because it provides continuous, objective data on the pressure inside the skull, which is crucial for managing severe head injuries in children. Unlike other treatments that may focus on symptoms, this monitoring helps guide therapy by ensuring that interventions for other injuries do not worsen brain pressure.348910

Research Team

RC

Randall Chesnut, MD

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for children aged 1-12 who have suffered a non-penetrating traumatic brain injury (TBI) and are admitted to the hospital within 24 hours of the incident. They must have a severe TBI, indicated by a low score on the Glasgow Coma Scale (GCS), and consent from parents or guardians. Children with injuries suspected to be caused intentionally or those with certain unresponsive pupil conditions cannot participate.

Inclusion Criteria

Provision of signed and dated informed consent form by the parent(s) or guardian(s)
I have had a traumatic brain injury that did not penetrate the skull.
I was admitted to the hospital within a day after getting injured.
See 3 more

Exclusion Criteria

I am in a deep coma with no eye response.
Motor GCS score of 6
Injury thought to be intentionally inflicted by a family member or caregiver.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment for severe traumatic brain injury guided by either ICP monitoring or imaging and clinical examination protocols

1 month
Inpatient ICU stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life and functional outcomes

6 months
Assessments at 3 and 6 months post-injury

Treatment Details

Interventions

  • CREVICE (Other)
  • ICP (Other)
Trial OverviewThe study compares two ways of treating severe pediatric TBI: one uses invasive monitoring of pressure inside the skull (ICP), while the other follows treatment protocols without such monitoring. The goal is to see which method leads to better recovery outcomes for these young patients.
Participant Groups
2Treatment groups
Active Control
Group I: No ICP Monitoring Protocol CREVICEActive Control1 Intervention
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
Group II: ICP monitoring based ProtocolActive Control1 Intervention
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

ICP is already approved in Canada for the following indications:

🇨🇦
Approved in Canada as Intracranial Pressure Monitoring for:
  • Severe Traumatic Brain Injury (TBI) in children

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

Dr. Timothy H. Dellit

University of Washington

Chief Executive Officer since 2023

MD from University of Washington

Dr. Anneliese Schleyer

University of Washington

Chief Medical Officer since 2023

MD, MHA

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

Collaborator

Trials
2,103
Recruited
2,760,000+
Dr. Diana W. Bianchi profile image

Dr. Diana W. Bianchi

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

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich profile image

Dr. Alison Cernich

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

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

Findings from Research

Increased intracranial pressure (ICP) is linked to poorer outcomes following traumatic brain injury (TBI), making ICP monitoring crucial for treatment decisions, especially in severe cases.
Current guidelines emphasize maintaining cerebral perfusion pressure and managing elevated ICP, with monitoring being a standard practice in developed countries for pediatric TBI.
Management of raised intracranial pressure in children with traumatic brain injury.Kukreti, V., Mohseni-Bod, H., Drake, J.[2020]
In a study of 1705 children with severe traumatic brain injury (TBI), those who underwent intracranial pressure (ICP) monitoring had a significantly lower in-hospital mortality rate of 11% compared to 14.3% overall, suggesting that ICP monitoring may improve outcomes.
The analysis indicated that hospitals with higher rates of ICP monitoring had a 51% lower odds of mortality for treated children, highlighting the potential benefit of ICP monitoring in managing severe TBI, although the overall impact on interhospital mortality variation was modest.
Intracranial pressure monitoring among children with severe traumatic brain injury.Alali, AS., Gomez, D., Sathya, C., et al.[2019]
In a study of pediatric trauma patients with severe head injuries, ICP monitoring was associated with a significant reduction in mortality for those with a Glasgow Coma Scale (GCS) score of 3, suggesting a potential survival benefit in this critical subgroup.
Despite the survival advantage, ICP monitoring was infrequently used (only 7.7% of eligible patients) and was linked to longer hospital stays and more ventilator days, indicating a trade-off between monitoring and resource use in pediatric intensive care.
Intracranial Pressure Monitoring in Children With Severe Traumatic Brain Injury: National Trauma Data Bank-Based Review of Outcomes.Alkhoury, F., Kyriakides, TC.[2022]

References

Management of raised intracranial pressure in children with traumatic brain injury. [2020]
Intracranial pressure monitoring among children with severe traumatic brain injury. [2019]
Intracranial Pressure Monitoring in Children With Severe Traumatic Brain Injury: National Trauma Data Bank-Based Review of Outcomes. [2022]
Intracranial pressure monitoring in the management of the pediatric trauma patient. [2019]
Intracranial Pressure Monitoring in Children With Severe Traumatic Brain Injury: A Propensity Score Matching Analysis Using a Nationwide Inpatient Database in Japan. [2023]
Intracranial pressure monitoring for traumatic brain injury in the modern era. [2021]
Is intracranial pressure monitoring useful in children with severe traumatic brain injury? [2018]
Risk factors of intracranial pressure monitoring in children with fiberoptic devices: a critical review. [2019]
Noninvasive Intracranial Pressure Monitoring for Severe Traumatic Brain Injury in Children: A Concise Update on Current Methods. [2018]
Intracranial Pressure Monitoring in Children with Severe Traumatic Brain Injury: A Retrospective Study. [2022]