Biomarkers of Brain Injury in Critically-Ill Children on Extracorporeal Membrane Oxygenation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 455
- 试验地点
- 11
- 主要终点
- Change in Vineland Adaptive Behavior Scales-Third Edition (VABS-3)
研究概览
简要总结
The BEAM study is a multicenter, prospective, observational study in children supported on extracorporeal membrane oxygenation (ECMO). The primary goals of this study are to develop and refine a brain injury multimarker panel for accurate neurologic monitoring at the bedside and early classification of mortality and disability outcomes of critically ill children supported on ECMO.
详细描述
The specific aims are to:
- Determine if circulating levels of brain injury markers during ECMO and brain MRI abnormalities within 6 weeks after ECMO are associated with survival at 18 months after ECMO with a score ≥85 on the Vineland Adaptive Behavior Scales, third edition (VABS-III).
- Determine whether the presence and degree of inflammation during ECMO and markers of neuroinflammation on brain magnetic resonance spectroscopy (MRS) within 6 weeks after ECMO are associated with survival at 18 months after ECMO with a score ≥85 on VABS-III.
- Determine whether metabolic and lipid neuroinflammatory pathways will distinguish between at-risk for, acute, and recovery phases of neurologic injury (NI) during ECMO.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (2 days to <18 years) cannulated onto ECMO and admitted to a pediatric or cardiac Intensive Care Unit at participating institutions.
排除标准
- •ECMO cannulation at an outside institution with transport to a study site >24 hours after ECMO initiation
- •Limitation of care (e.g., family planning to withdraw support)
- •Brain death evaluation within 24 hours of ECMO cannulation
- •Inability to speak or understand English or Spanish
- •Pregnancy.
结局指标
主要结局
Change in Vineland Adaptive Behavior Scales-Third Edition (VABS-3)
时间窗: Baseline and 18 months post-ECMO
VABS-3 is a 381-item caregiver report measure that was developed to assess adaptive behavior. The questionnaire is divided into 4 domains of adaptive behavior: 1) communication, 2) daily living, 3) social skills and relationships, and 4) physical activity. Each item is rated 0 (never), 1 (sometimes), or 2 (usually or often) as how often the child does the behavior independently without help or reminders. The overall adaptive composite score has a mean of 100 and standard deviation of 15 with lower scores indicating worse intellectual disability.
次要结局
- Change in Pediatric Cerebral Performance Category (PCPC)(Baseline and at hospital discharge, up to 18 months post-ECMO)
- Change in Functional Status Scale (FSS)(Baseline and at hospital discharge, up to 18 months post-ECMO)
- Consumer Assessment of Healthcare Providers and Systems (CAHPS) Child Survey 5.0H with the Children with Chronic Conditions (CCC) Item Set(18 months post-ECMO)
- Change in Pediatric Quality of Life (PedsQL) Inventory(Baseline and 18 months post-ECMO)
- Change in Pediatric Overall Performance Category (POPC)(Baseline and at hospital discharge, up to 18 months post-ECMO)