Salivary Biomarkers in Pediatric Traumatic Brain Injury

NCT ID: NCT02609568

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 77 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-16
• Study Completion Date: 2017-03-30

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.

Conditions

Traumatic Brain Injury

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control Group 1

Children with non-trauma complaints

No interventions assigned to this group

Control Group 2

Children with non TBI and musculoskeletal trauma

No interventions assigned to this group

Cases

Children admitted to hospital with moderate/severe isolatedTBI

No interventions assigned to this group

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valleywise Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudia Yeung, MD

Role: STUDY_DIRECTOR

Valleywise Health

Kevin Foster, MD

Role: STUDY_DIRECTOR

Valleywise Health

Locations

Maricopa Integrated Health System

Phoenix, Arizona, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23399646 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21524681 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

2014-055

Identifier Type: -

Identifier Source: org_study_id