Studying the Significance of Salivary Biomarkers in Pediatric Traumatic Brain Injury
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Traumatic Brain Injury
- Sponsor
- Valleywise Health
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Levels of 3 specific salivary biomarkers (GFAP, S100B, and NSE)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
By studying individual biomarkers in body fluids such as saliva, there is a potential for detecting injury to the brain resulting from an acute traumatic even that may not be detectable by conventional neuroimaging like CT scans.
Detailed Description
Although identification of biomarkers following TBI is a rather novel area of research, few studies that have been done in patients with severe TBI and biomarkers from serum and cerebrospinal fluid have shown to have prognostic significance. However there are no prior studies looking at biomarkers in salivary specimens. In this study we will include patients with moderate and severe TBI who require inpatient admission, and will study 3 specific salivary biomarkers. This is a unique project, since salivary specimen collection is easy and non-invasive and can be collected at any site even on a sports field by using a simple absorbable swab resembling a cigarette stub, unlike blood or CSF that can be highly invasive. Salivary specimens can also be frozen and stored for long periods of time prior to testing. If our study detects abnormalities in levels of these biomarkers when compared to healthy controls, and children with extra-cerebral injuries, in future studies we can look at children and adolescents with minor head traumas and concussions who are discharged from the emergency department after evaluation, and study their long-term outcomes and correlation with salivary biomarkers. Specific aims: To study levels of three specific biomarkers in salivary specimens (GFAP, S100B and NSE) in children with moderate TBI (GCS: 9-12) and severe TBI (GCS: \<8) admitted to a pediatric trauma referral center. These biomarkers have been shown to have prognostic significance in prior studies using serum and CSF.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Children aged 0 to 20 who present to the pediatric ED or trauma bay with an isolated acute head injury (moderate or severe) and are admitted for inpatient management;
- •Pediatric patients who present to the ED with non-trauma complaints; and
- •Pediatric patients who present to the ED with non-head trauma such as musculoskeletal injuries.
Exclusion Criteria
- •Patients with multisystem trauma;
- •Patients with minor head trauma (GCS 13-15) discharged from the pediatric ED
- •Patients with other pre-existing neurological conditions (such as cerebral palsy, chronic seizure disorder, VP shunts);
- •Patients with a history suggestive of head trauma from chronic abuse;
- •Incarcerated patients or patients from juvenile detention facilities;
- •Refusal of parent/patient to participate for any specific reason.
Outcomes
Primary Outcomes
Levels of 3 specific salivary biomarkers (GFAP, S100B, and NSE)
Time Frame: Within 24 hours of injury
Within 24 hours of an acute isolated TBI
Secondary Outcomes
- Glasgow Coma Scale measurement of injury severity(Day 1)
- Need for neurosurgical intervention including ICP monitor(During hospitalization (up to 50 days))
- Patient's Length of Stay or hospitalization(Duration of hospitalization (up to 50 days))
- Brain CT Scan abnormalities suggesting significant brain injury(Within 24 hours of injury)
- Need for mechanical ventilation(During hospitalization (up to 50 days))
- Final disposition(At end of hospitalization (up to 50 days))