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OpenTrials
Completed

NCT Number: NCT02609568

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maricopa Integrated Health System

Phoenix, Arizona, 85008, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Valleywise Health

Other

Registry information

Official study title

Studying the Significance of Salivary Biomarkers in Pediatric Traumatic Brain Injury

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 20, 2015
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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