Functional Recovery in Critically Ill Children - a Longitudinal Multicentre, Mixed-Methods Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- Functional Recovery
研究概览
简要总结
When children suffer from a critical-illness, the investigators focus on resuscitating and saving lives. Once these children leave the pediatric intensive care unit, very little is known about what happens to them - how long it takes for them to recover, how families cope, and what factors that impede their recovery. The specific objective of this research project is to evaluate how children and their families recover after a critical illness.
Research Hypotheses: Following a critical illness in children, 1) the rate and degree of health and functional recovery is influenced by the following factors: age, pre-admission co-morbid status, critical illness severity, discharge functional status, and time to initiating acute rehabilitation; 2) functional recovery is influenced by caregiver burden and health-related quality-of-life (HRQoL).
详细描述
The Specific Objective of this study is to evaluate the trajectory of health and functional outcomes in children following a critical illness, define poor functional recovery, and evaluate predictors of poor recovery.
The Research Questions for this study are: 1) What are the health and functional outcomes in children affected by a critical illness, at 3 and 6 months following Pediatric Intensive Care Unit (PICU) discharge? 2) What defines poor functional recovery? 3) What are predictors of poor functional recovery in critically ill children? 4) What are the most important and relevant outcomes in critically ill children, from the patient and caregiver's point of view?
Study Design: Prospective Observational Mixed Methods Longitudinal Cohort Study Study Setting: Two Academic Pediatric Centres in Canada - McMaster Children's Hospital and London Health Sciences Centre.
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
- 12 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 12 months to 17 years
- •Admitted to PICU for at least 48 hours
- •≥ one organ dysfunction on admission
- •Informed consent of patient/substitute decision maker, and patient assent were appropriate
排除标准
- •Patients transferred directly from a neonatal intensive care unit prior to discharge home
- •Patients who are already mobilizing well, or are at baseline functional status at time of screening
- •Previous enrolment into this study
- •Language barrier (i.e. no access to translation services)
结局指标
主要结局
Functional Recovery
时间窗: In the first 6 months following Pediatric Intensive Care Unit Discharge
Functional Status will be measured at PICU discharge, 3 and 6 months post discharge using the following measurement tools: Pediatric Evaluation of Disability Inventory (PEDI), and the Participation and Environment Measure - children and youth versions (PEM-CY/YC-PEM).
Predictors of Functional Recovery
时间窗: 6 months post PICU discharge
The following hypothesized determinants of functional recovery will be evaluated: age, critical illness severity, pre-admission co-morbid status, PICU discharge functional status, and time to rehabilitation.
次要结局
- Additional components of functional health(The first 6 months post PICU discharge)