Genetic Variability and Biomarkers in Children With Acute Lung Injury
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Development of ALI or ARDS
研究概览
简要总结
Acute Lung Injury (ALI) and the more severe Acute Respiratory Distress Syndrome (ARDS) are a significant problem in Pediatric Intensive Care Units, affecting up to 16 of every 1000 children admitted to these units. These disorders carry with them high mortality rates as well as numerous long-term effects for the surviving children. As the effects of these diseases have significant social and economic ramifications for affected children and their families, research on the development of ALI/ARDS could significantly change how physicians understand the disease and treat patients.
There are a wide range of problems which make certain PICU patients more likely to develop either ALI or ARDS. This research aims to determine which of these children are at the greatest risk for ALI/ARDS by examining differences in plasma biomarkers and in DNA of a large number of PICU patients. We are hypothesizing that significant differences in the level of specific plasma biomarkers or in the frequency of specific DNA variants exist in children who develop ALI/ARDS.
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
- 2 Weeks 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive intubated pediatric patients (≥ 2 weeks of age and ≥ 42 weeks corrected gestational age and ≤ 18 years of age) supported on mechanical ventilation for acute pulmonary parenchymal disease enrolled in the RESTORE study.
排除标准
- •Intubated and mechanically ventilated for immediate post-operative care and stabilization
- •Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt
- •History of single ventricle at any stage of repair
- •Congenital diaphragmatic hernia or paralysis
- •Primary pulmonary hypertension
- •Critical airway (e.g., post laryngotracheal construction) or anatomical obstruction of the lower airway (e.g., mediastinal mass)
- •Ventilator dependent (including noninvasive) on PICU admission (chronic assisted ventilation)
- •Neuromuscular respiratory failure
- •Spinal cord injury above the lumbar region
- •Pain managed by patient controlled analgesia (PCA) or epidural catheter
- •Family/medical team has decided not to provide full support (patient treatment considered futile)
- •Enrolled in any other sedation clinical trial concurrently or within the last 30 days
- •Known allergy to any of the study medications
结局指标
主要结局
Development of ALI or ARDS
时间窗: During PICU stay
次要结局
未报告次要终点