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Intracranial Pressure Monitoring for Pediatric Traumatic Brain Injury (BELA TRIPP Trial)

N/A
Recruiting
Led By Randall Chesnut, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 and 6 months
Awards & highlights

Summary

This trial will compare two ways of treating children with severe traumatic brain injury. One group will be treated with a protocol that includes invasive intracranial pressure monitoring, and the other group will be treated without it. The goal is to see if the first group has better outcomes.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not detailed here, invasive ICP monitoring may include risks like infection, bleeding in the brain, or reactions at the site where equipment enters the body. Non-invasive treatments carry their own set of potential risks depending on what they entail.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Brain-specific interventions
Glasgow Outcome Scale - Extended (GOS-E) Pediatric
ICU length of stay
+2 more

Trial Design

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

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,762 Previous Clinical Trials
1,876,054 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,988 Previous Clinical Trials
2,683,095 Total Patients Enrolled
Randall Chesnut, MDPrincipal InvestigatorUniversity of Washington

Media Library

ICP (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05566431 — N/A
Traumatic Brain Injury Research Study Groups: No ICP Monitoring Protocol CREVICE, ICP monitoring based Protocol
Traumatic Brain Injury Clinical Trial 2023: ICP Highlights & Side Effects. Trial Name: NCT05566431 — N/A
ICP (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05566431 — N/A
~257 spots leftby Jul 2026
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