Genetic Variability and Biomarkers in Children With Acute Lung Injury (BALI)
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.
研究概览
研究类型
联系人和位置
学习地点
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Wisconsin
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Milwaukee、Wisconsin、美国、53226
- Children's Hospital of Wisconsin
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Non ALI/ARDS
Those patient who enrolled in the study but did not develop ALI or ARDS during their hospital course.
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ALI/ARDS
Those patients who enrolled in the study and developed ALI or ARDS during their hospital course.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Development of ALI or ARDS
大体时间：During PICU stay
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During PICU stay
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合作者和调查者
合作者
调查人员
- 首席研究员：Michael Quasney, PhD, MD、Medical College of Wisconsin
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.