After Pediatric Critical Illness (APCI)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 690
- 试验地点
- 8
- 主要终点
- Develop and validate a model predictive of PICS-p 2 months post PICU
研究概览
简要总结
More than 10,000 children are hospitalized in an PICU every year in Canada. While most of them will survive their PICU hospitalization and their critical illness, some children will not recover to their pre-illness level. Some may develop behavioral, physical, emotional or developmental problems and difficulties at school. All these problems are elements that are part of the Pediatric Post-Intensive Care Syndrome (PICS-p).
It is important to understand the elements (risk factors) that play a role in the development of PICS-p. In Canada, there is no systematic follow-up for children after they leave the PICU. Understanding what can cause PICS-p (risk factors) and how much PICS-p has an impact on children and their family is very important to the family well-being.
详细描述
The Pediatric Post-Intensive Care Syndrome (PICS-p) is a newly developed conceptual framework that incorporates the constellation of morbidities that are increasingly recognized to affect children and their families after a critical illness. Experts define PICS-p as a new or worsening impairment in any of the following 5 domains of child health: physical, cognitive, emotional, social, or family.
In contrast to well established follow-up programs in adults, there is currently a lack of systematic follow-up of PICU survivors which prevents both the recognition and management of PICS-p. The absence of granular, empirical data on the recovery of PICU children impedes both the identification and management of PICS-p.
This project is a prospective Canadian multicenter cohort study to identify risk factors of PICS-p, develop and validate a predictive model for PICS-p to detect at-risk children, characterize each domain of PICS-p over two years post critical illness and uncover additional morbidities that are not captured using the current PICS-p framework. This study will provide granular, empirical data on which to build developmentally appropriate and tailored screening, management, and intervention programs during and after PICU to improve the global recovery of critically ill children and their family.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ≤18yo hospitalized in PICU for ≥96 hours
排除标准
- •gestational age <37 weeks or age >18 years at PICU entry;
- •admitted for congenital heart surgery (followed in neuro-cardiac clinics in most centers);
- •anticipated life expectancy <1year (e.g., active do not resuscitate status).
结局指标
主要结局
Develop and validate a model predictive of PICS-p 2 months post PICU
时间窗: 2 months after PICU discharge
The model will allow detection at PICU discharge of children in need of post-PICU follow-up
Identify risk factors of PICS-p at 2 months post-PICU
时间窗: 2 months after PICU discharge
Identification of modifiable and non-modifiable risk factors
次要结局
- Describe the incidence of each of the five domains of PICS-p across the first two years post-PICU(At 2 months, 12, 18 months and 36 months post PICU discharge)
- Uncover additional post-PICU morbidities not detected within the framework of PICS-p.(Until 36 months post PICU discharge)
研究者
Genevieve Du Pont-Thibodeau
MD
St. Justine's Hospital