N/A
Completed N=116
Pediatric Guideline Adherence and Outcomes- Argentina
TBI (Traumatic Brain Injury)
Source: ClinicalTrials.gov NCT03896789 ↗
Enrolled (actual)
116
Serious AEs
12.7%
Results posted
Jan 2025
Primary outcomePrimary: 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
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.
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 | — |
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. Informational only — not medical advice.