Salivary Biomarkers in Pediatric Traumatic Brain Injury



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any - 18
Updated:4/21/2016
Start Date:August 2014
End Date:July 2016
Contact:Claudia Yeung, MD
Email:claudia_yeung@dmgaz.org

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Studying the Significance of Salivary Biomarkers in Pediatric Traumatic Brain Injury

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.

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.

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.
We found this trial at
1
site
2619 E. Pierce St.
Phoenix, Arizona 85008
602-344-5951
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from
Phoenix, AZ
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