Clinical trial NCT02609568: Salivary Biomarkers in Pediatric Traumatic Brain Injury
Official title: Studying the Significance of Salivary Biomarkers in Pediatric Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: Children
Head injury
Salivary biomarker
Trauma Brain Injury
Lead sponsor: Valleywise Health
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 77
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1) 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; 2) pediatric patients who present to the ED with non-trauma complaints; and 3) pediatric patients who present to the ED with non-head trauma such as musculoskeletal injuries.

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.

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.

Primary outcomes:
measure: Levels of 3 specific salivary biomarkers (GFAP, S100B, and NSE)
timeFrame: Within 24 hours of injury
Secondary outcomes:
measure: Glasgow Coma Scale measurement of injury severity
timeFrame: Day 1
measure: Brain CT Scan abnormalities suggesting significant brain injury
timeFrame: Within 24 hours of injury
measure: Need for mechanical ventilation
timeFrame: During hospitalization (up to 50 days)
measure: Need for neurosurgical intervention including ICP monitor
timeFrame: During hospitalization (up to 50 days)
measure: Patient's Length of Stay or hospitalization
timeFrame: Duration of hospitalization (up to 50 days)
measure: Final disposition
timeFrame: At end of hospitalization (up to 50 days)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa Integrated Health System
state: Arizona
Study officials:
affiliation: Valleywise Health
name: Claudia Yeung, MD
role: STUDY_DIRECTOR
affiliation: Valleywise Health
name: Kevin Foster, MD
role: STUDY_DIRECTOR
References:
citation: Zetterberg H, Smith DH, Blennow K. Biomarkers of mild traumatic brain injury in cerebrospinal fluid and blood. Nat Rev Neurol. 2013 Apr;9(4):201-10. doi: 10.1038/nrneurol.2013.9. Epub 2013 Feb 12.
citation: Olsson B, Zetterberg H, Hampel H, Blennow K. Biomarker-based dissection of neurodegenerative diseases. Prog Neurobiol. 2011 Dec;95(4):520-34. doi: 10.1016/j.pneurobio.2011.04.006. Epub 2011 Apr 16.
citation: Faul M, Xu L, Wald MM, Coronado V. Traumatic brain injury in the United States: emergency department visits, hospitalizations, and deaths, 2002--2006. Atlanta, GA: CDC, National Center for Injury Prevention and Control; 2010.