N/A
N=116
Pediatric Guideline Adherence and Outcomes- Argentina
TBI (Traumatic Brain Injury)
Bottom Line
View on ClinicalTrials.gov: NCT03896789 ↗Enrolled (actual)
116
Serious AEs
12.7%
Results posted
Jan 2025
Primary outcome: Primary: First 3-day Cumulative Intensive Care Unit (ICU) Traumatic Brain Injury (TBI) Guideline Adherence Rate, Overall — 81.7; 81.0; 83.7; 84.4 mean percentage of guideline adherence — p=.95
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PEGASUS Program for Care (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY First 3-day Cumulative Intensive Care Unit (ICU) Traumatic Brain Injury (TBI) Guideline Adherence Rate, Overall |
81.7; 81.0; 83.7; 84.4 | .95 |
| SECONDARY Clinical Pathway Adoption |
11; 170; 0 | — |
| SECONDARY Glasgow Outcome Scale (GOS) Score at Discharge |
3; 6; 0; 2; 5; 4 | — |
| SECONDARY Discharge Survival |
3; 6; 52; 55; 12; 13 | — |
| SECONDARY Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) |
0; 0; 0; 2; 5; 8 | — |
| SECONDARY Mortality, 3-Month |
0; 0; 51; 53; 0; 0 | — |
Summary
Pediatric traumatic brain injury (TBI) is the leading killer of children worldwide but effective treatments for TBI are limited. Although evidenced-based pediatric TBI guidelines exist, adherence to these guidelines is low,leading us to develop a new Pediatric Guideline Adherence and Outcomes (PEGASUS) program to increase TBI guideline adherence. We propose to test the PEGASUS program's ability to improve TBI guideline adherence and outcomes.
Eligibility Criteria
Inclusion Criteria
- Mechanism or head CT consistent with TBI
- <18 years old
- Glasgow Coma Scale (GCS) score ≤8 at any point during hospital admission, motor GCS≤5 if intubated
Exclusion Criteria
- none
Data sourced from ClinicalTrials.gov (NCT03896789). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.