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Salivary Biomarkers in Pediatric Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609568
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Valleywise Health

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.

Condition or disease
Traumatic Brain Injury

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.

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Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Studying the Significance of Salivary Biomarkers in Pediatric Traumatic Brain Injury
Actual Study Start Date : April 16, 2014
Actual Primary Completion Date : March 17, 2017
Actual Study Completion Date : March 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Control Group 1
Children with non-trauma complaints
Control Group 2
Children with non TBI and musculoskeletal trauma
Cases
Children admitted to hospital with moderate/severe isolatedTBI



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Glasgow Coma Scale measurement of injury severity [ Time Frame: Day 1 ]
    Glasgow Coma Scale is a score between 3 and 15, 3 being the worst, and 15 the best. It is composed of three parameters: Best Eye Response, Best Verbal Response, and Best Motor Response. A Coma Score of 13 or higher correlates with a mild brain injury, 9 to 12 is a moderate injury and 8 or less a severe brain injury.

  2. Brain CT Scan abnormalities suggesting significant brain injury [ Time Frame: Within 24 hours of injury ]
    Dichotomous measure: presence or absence of such abnormalities

  3. Need for mechanical ventilation [ Time Frame: During hospitalization (up to 50 days) ]
    Mechanical ventilators are used for patients who cannot breathe by themselves. Dichotomous measure: whether or not mechanical ventilation is needed.

  4. Need for neurosurgical intervention including ICP monitor [ Time Frame: During hospitalization (up to 50 days) ]
    Dichotomous measure: whether or not neurosurgical intervention is needed

  5. Patient's Length of Stay or hospitalization [ Time Frame: Duration of hospitalization (up to 50 days) ]
    Number of days spent in hospital

  6. Final disposition [ Time Frame: At end of hospitalization (up to 50 days) ]
    Polytomous measure: Discharge to home, discharge to rehab, or death


Biospecimen Retention:   Samples Without DNA
Salivary biomarkers: S100B, neuron-specific enolase, GFAP


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609568


Locations
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United States, Arizona
Maricopa Integrated Health System
Phoenix, Arizona, United States, 85008
Sponsors and Collaborators
Valleywise Health
Investigators
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Study Director: Claudia Yeung, MD Valleywise Health
Study Director: Kevin Foster, MD Valleywise Health

Publications:
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Responsible Party: Valleywise Health
ClinicalTrials.gov Identifier: NCT02609568    
Other Study ID Numbers: 2014-055
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Keywords provided by Valleywise Health:
Children
Head injury
Salivary biomarker
Trauma Brain Injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System