Studying the Significance of Salivary Biomarkers in Pediatric Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Levels of 3 specific salivary biomarkers (GFAP, S100B, and NSE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Levels of 3 specific salivary biomarkers (GFAP, S100B, and NSE)
时间窗: Within 24 hours of injury
Within 24 hours of an acute isolated TBI
次要结局
- Glasgow Coma Scale measurement of injury severity(Day 1)
- Need for neurosurgical intervention including ICP monitor(During hospitalization (up to 50 days))
- Patient's Length of Stay or hospitalization(Duration of hospitalization (up to 50 days))
- Brain CT Scan abnormalities suggesting significant brain injury(Within 24 hours of injury)
- Need for mechanical ventilation(During hospitalization (up to 50 days))
- Final disposition(At end of hospitalization (up to 50 days))