Intracranial Pressure Monitoring for Pediatric Traumatic Brain Injury

(BELA TRIPP Trial)

Recruiting at 12 trial locations

Overseen By Kelley Chaddock, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Motor GCS score 6, GCS 3 with fixed pupils, intentional injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 month

428 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best treatment for severe traumatic brain injury (TBI) in children by comparing two methods. One group receives treatment guided by intracranial pressure (ICP) monitoring, which checks the pressure inside the skull. The other group follows a protocol based on imaging and physical exams without invasive monitoring. The goal is to determine if one approach aids recovery better than the other. Suitable candidates for this trial are children aged 1-12 who have suffered a severe non-penetrating head injury and are admitted to the hospital within 24 hours of the injury. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve future treatment strategies for children with severe TBI.

Will I have to stop taking my current medications?

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

What prior data suggests that intracranial pressure monitoring is safe for pediatric traumatic brain injury?

Research has shown that monitoring pressure inside the skull can be safely conducted in children with severe head injuries. One study performed this procedure without causing additional harm, but it did not lower the risk of death or the need for further brain surgeries. Another study found that while this monitoring might increase survival rates, it did not improve long-term recovery. For example, some children scored lower on a test measuring everyday skills six months after treatment. Although generally well-tolerated, this monitoring has not clearly demonstrated benefits in reducing serious complications from head injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different approaches to managing severe traumatic brain injury in children. One approach uses invasive intracranial pressure (ICP) monitoring, which is guided by the Brain Trauma Foundation Guidelines, to provide precise measurements of pressure inside the skull. This can help tailor treatment to prevent further brain injury. The other approach, known as the CREVICE protocol, avoids invasive monitoring and relies on imaging and clinical examination for decision-making. By comparing these two methods, researchers hope to determine the most effective way to manage pediatric traumatic brain injuries, potentially improving outcomes and reducing risks associated with invasive procedures.

What evidence suggests that intracranial pressure monitoring is effective for pediatric traumatic brain injury?

This trial will compare two approaches for managing pediatric severe traumatic brain injury. One arm will use a protocol based on invasive intracranial pressure (ICP) monitoring, while the other will follow the CREVICE protocol, which does not involve ICP monitoring. Research has shown mixed results regarding the effectiveness of monitoring pressure inside the skull in treating children with serious brain injuries. Some studies suggest that while this monitoring can increase survival rates, it might not lead to better long-term recovery. For example, one study found that monitoring improved survival rates but didn't necessarily enhance long-term recovery. Another review noted that monitoring might not reduce in-hospital deaths, possibly due to the severity of the injuries. Overall, the evidence on the impact of this monitoring remains unclear, with results varying based on different factors. ^{1 2 6 7 8}

Who Is on the Research Team?

Randall Chesnut, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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)

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)

I have had a traumatic brain injury that did not penetrate the skull.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• CREVICE
• ICP

Trial Overview The 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.

How Is the Trial Designed?

Group I: No ICP Monitoring Protocol CREVICE Active Control 1 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 Protocol Active Control 1 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 European Union, United States, Canada for the following indications:

Approved in European Union as Intracranial Pressure Monitoring for:

• Severe Traumatic Brain Injury (TBI) in children

Approved in United States as Intracranial Pressure Monitoring for:

• Severe Traumatic Brain Injury (TBI) in children

Approved in Canada as Intracranial Pressure Monitoring for:

• Severe Traumatic Brain Injury (TBI) in children

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

Transcranial Doppler and optic nerve sheath diameter assessments are identified as the most effective noninvasive methods for monitoring intracranial pressure (ICP) in pediatric traumatic brain injury (TBI), based on a review of 27 studies.

While invasive ICP monitoring remains the gold standard, the noninvasive techniques offer promising advantages such as high sensitivity and diagnostic accuracy, potentially making them the future of neurointensive care for children with TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Intracranial Pressure Monitoring for Severe Traumatic Brain Injury in Children: A Concise Update on Current Methods. Narayan, V., Mohammed, N., Savardekar, AR., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of raised intracranial pressure in children with traumatic brain injury. Kukreti, V., Mohseni-Bod, H., Drake, J.[2020]

In a study of 98 children with severe head injuries, fiberoptic intracranial pressure (ICP) monitoring was found to be safe and effective, with no complications during device insertion and a low infection rate (7% positive cultures) despite prolonged monitoring.

The study reported a 13% mechanical failure rate of the fiberoptic device, but overall, the monitoring technique showed minimal risk of complications and was effective in managing severe head injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors of intracranial pressure monitoring in children with fiberoptic devices: a critical review. Jensen, RL., Hahn, YS., Ciro, E.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial Pressure Monitoring in Children With Severe Traumatic Brain Injury: National Trauma Data Bank-Based Review of Outcomes. Alkhoury, F., Kyriakides, TC.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial pressure monitoring among children with severe traumatic brain injury. Alali, AS., Gomez, D., Sathya, C., et al.[2019]

In a study of children aged 1 to 12 with severe traumatic brain injury (TBI), intracranial pressure (ICP) monitoring did not show any significant benefits in terms of reducing mortality or the need for cranial surgeries compared to those who were not monitored.

The study found no differences in the duration of mechanical ventilation, length of hospital stay, or outcomes at discharge between the ICP monitored group and the control group, suggesting that ICP monitoring may not be necessary in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial Pressure Monitoring in Children with Severe Traumatic Brain Injury: A Retrospective Study. Banik, S., Rath, GP., Lamsal, R., et al.[2022]

In a study of 2116 children with severe traumatic brain injury (TBI), those who underwent intracranial pressure (ICP) monitoring on admission had a significantly lower in-hospital mortality rate (12.7%) compared to those who did not receive monitoring (17.9%).

The benefits of ICP monitoring were particularly pronounced in children with severe disturbances of consciousness, suggesting that it may be a crucial intervention for improving outcomes in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial Pressure Monitoring in Children With Severe Traumatic Brain Injury: A Propensity Score Matching Analysis Using a Nationwide Inpatient Database in Japan. Shibahashi, K., Ohbe, H., Matsui, H., et al.[2023]

Continuous monitoring of intracranial pressure (ICP) has been a key practice in managing traumatic brain injury (TBI) for nearly 60 years, but there are no randomized trials confirming its direct benefits.

Clinical evidence suggests that ICP monitoring can lead to improved treatment outcomes when integrated into protocol-driven therapy, although it may also have adverse effects and raises unresolved questions, especially in pediatric cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial pressure monitoring for traumatic brain injury in the modern era. Padayachy, LC., Figaji, AA., Bullock, MR.[2021]

Intracranial pressure (ICP) monitoring is crucial for managing severely injured children with major head trauma, as demonstrated in a case study of 18 patients with multiple traumas, where it guided appropriate therapy.

The study highlights the importance of early ICP monitoring to ensure optimal care, especially when treatments for other injuries could negatively impact ICP levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial pressure monitoring in the management of the pediatric trauma patient. Caniano, DA., Nugent, SK., Rogers, MC., et al.[2019]

In a study of children with severe traumatic brain injury (TBI), those who underwent intracranial pressure (ICP) monitoring had a significantly better outcome, with only 16.7% experiencing unfavorable results compared to 55% in those who did not have monitoring.

Children without ICP monitoring required more hyperosmolar agents but had shorter ventilation times and ICU stays, suggesting that ICP monitoring may lead to more effective management of severe TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is intracranial pressure monitoring useful in children with severe traumatic brain injury? Arunkumar, S., Devi, BI., Shukla, D., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11955484/

Effects of intracranial pressure monitoring in pediatric ... This meta-analysis found no overall reduction in in-hospital mortality with ICP monitoring in pediatric severe TBI, potentially due to baseline severity ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2831225

The Path From Intracranial Pressure to Clinical Outcomes ... Current pediatric guidelines recommend bolus 3% HTS to rapidly reduce ICP and improve cerebral perfusion pressure (CPP).

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28846763/

Functional Outcome After Intracranial Pressure Monitoring for ... Overall, 484 children (15.7%) experienced the primary composite outcome. A propensity approach using matching weights generated good covariate ...

4. academic.oup.com academic.oup.com/jamia/advance-article/doi/10.1093/jamia/ocaf120/8220392

Predicting intracranial pressure monitor placement in children ... Variation in intracranial pressure monitoring and outcomes in pediatric traumatic brain injury . Arch Pediatr Adolesc Med . 2012. ;. 166. : 641.

5. journals.lww.com journals.lww.com/ccmjournal/fulltext/2024/01001/1575__icp_monitoring_improves_mortality_but_not.1518.aspx

1575: icp monitoring improves mortality but not functional ... Patients who received ICP monitoring were more likely to have subarachnoid (47.7% vs. 26.8%, p< 0.001) and subdural hemorrhage (39.6% vs. 28.5%, ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2809949

Intracranial Pressure Monitoring and 6-Month Outcomes of ... Patients who underwent ICP monitoring had a worse Glasgow Outcome Scale–Extended score at 6 months than the matched, nonmonitored control patients.

7. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2019.01376/full

Monitoring and Measurement of Intracranial Pressure in ... ICP monitoring in pediatric TBI relates to the 10% who suffer a moderate or severe head trauma with a higher risk of intracranial complications (60).

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6601117/

Intracranial Pressure Monitoring in Children with Severe ... In this study, ICP monitoring was safely conducted in children with severe TBI. However, monitoring did not reduce the incidence of death, cranial surgeries, ...