Study Purpose:

The purpose of this study is to evaluate the utility of salivary biomarkers in predicting pediatric TBI and establish saliva as a non-invasive diagnostic measure.

 

Study Summary:

 In the United States, the highest rates of traumatic brain injury (TBI) related emergency department visits occur in young children, followed by adolescents. TBI causes biochemical changes detectable in body fluids. Over the past decade, research in serum and cerebral spinal fluid TBI biomarkers has shown promise as a diagnostic and prognostic tool, correlating with injury severity. The use of saliva as a diagnostic tool has emerged as an exciting possibility for non-invasive disease detection. Children have specific language and cognitive limitations related to their age that can make clinical determination of TBI more difficult. A salivary test with diagnostic and prognostic relevance for TBI would be particularly useful in this patient population given the ease of specimen, as well as the lack of exposure radiation.

 

Basic Eligibility Criteria:

Patients ages 0-18 years presenting to the pediatric ED as a level I or II trauma activation with an isolated acute (<24 hours duration) head injury will be eligible for study enrollment. For the comparison groups, we will recruit patients presenting to the ED with: 1) medical complaints only, 2) musculoskeletal injury only.

Exclusion criteria include: any patient who does not receive a head CT; patients with multisystem trauma, including long bone extremity fracture, significant thoracic trauma, and significant intraabdominal injuries; patients with pre-existing neurological conditions (such as cerebral palsy, seizure disorder, VP shunt); incarcerated patients or patients from juvenile detention facilities; refusal of parent/patient to participate for any reason.

 

Study Location(s):

Phoenix Children’s Hospital

 

Study Contact(s):

Claudia Yeung, MD.

Zebulon Timmons, MD.  602-933-2266

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