Delirium in Children Undergoing Stem Cell Transplantation: Epidemiology and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,040
- 试验地点
- 6
- 主要终点
- Delirium incidence
研究概览
简要总结
Children undergoing stem cell transplants are at risk for delirium, a temporary change in thinking and behavior. This study will define delirium rates, risk factors, and outcomes. Our eventual goal is to reduce delirium in this population.
详细描述
Delirium -- defined as an acute change in awareness and cognition that occurs in the setting of an underlying illness -- is a common complication of hematopoietic stem cell transplantation (HSCT) in adults, with associated morbidity and mortality. This has never been studied in children, where risk factors may vary substantially from adults. The objectives of this study are: to define the epidemiology of delirium, and measure its effect on outcomes.
This prospective longitudinal cohort study will prospectively establish the incidence of delirium in 1000 children in the peri-transplant period, and identify modifiable risk factors that predispose to delirium development. This study will also define the effect of delirium on important clinical outcomes, including neurocognitive function. This study will be executed by a research consortium of five leading pediatric oncologic transplant centers in North America, in collaboration with the leading pediatric delirium research group in the United States.
This innovative proposal will leverage the combined experience of the pediatric delirium and HSCT teams to expand urgently needed delirium research into a unique and unstudied population. By reducing delirium rates, outcomes after pediatric HSCT can be optimized.
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0-21 years old
- •Admitted for purpose of stem cell transplant
排除标准
- •Age >21 years old
- •Admitted for reason other than stem cell transplant (example: late post-transplant complications).
结局指标
主要结局
Delirium incidence
时间窗: 1-50 days
Number of patients who develop delirium during the course of their transplant hospitalization
次要结局
- Hospital length of stay(1-365 days)
- Mortality rate(1-5 years)
- Readmission rate(1-365 days)
- Change in neurocognitive functioning as measured by the NIH Toolbox Cognition Battery(pre-transplant, 3 months after transplant, 12 months after transplant)