Identification of Pediatric Acute Respiratory Distress Syndrome Subtypes by Bronchial and Nasal Epithelial Transcriptomics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Identification of PARDS Endotypes
研究概览
简要总结
Pediatric acute respiratory distress syndrome (PARDS) is a severe and diffuse lung injury that is a common cause of admission and mortality in the pediatric intensive care unit (PICU). PARDS can be secondary to many different causes, and there are few therapies that have been shown beneficial in PARDS. This study seeks to identify important PARDS subtypes using gene expression profiling of bronchial epithelial cells from control and PARDS subjects.
详细描述
Enrolled subjects will have nasal brushings collected at days 1, 3, 7, and 14 of intubation with collection of serum at these same time points. Brushing RNA will be processed by mRNA-Seq for gene expression analysis and compared to previously published serum biomarkers (interleukin-8, advanced glycosylation end-product specific receptor, and angiopoietin-2) to assess correlation and ability to discriminate PARDS endotypes. Changes in gene expression over time will be assessed to define a PARDS recovery gene expression signature, and correlation between bronchial and nasal gene expression will be determined.
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
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All potential participants must:
- •Be aged zero to 18 years (both control and ARDS, not age matched)
- •Be admitted to the PICU with expected duration of hospitalization 7 days or greater.
- •ARDS patients must:
- •Have acute changes in chest x-ray (CXR)
- •Have a known or suspected insult within the prior 7 days that is consistent with ARDS
- •Have an oxygenation index (OI) of 4 or greater or and oxygen-sat index (OSI) of 5 or greater
- •OI = mean airway pressure X fraction inspired oxygen (FiO2) / arterial oxygen partial pressure (PaO2)
- •OSI = mean airway pressure X FiO2 / oxyhemoglobin saturation (SpO2) with sat <= 97%.
排除标准
- •Have a baseline oxygen requirement of 2 liters of oxygen or greater at home
- •Have disruption of the nasal passages
- •Have a history of excessive bleeding or known bleeding disorders
- •Be at high risk of bleeding
- •Have a do not resuscitate (DNR) or Limited Resuscitation Order
结局指标
主要结局
Identification of PARDS Endotypes
时间窗: 6 years
Use of unbiased cluster analysis of gene expression to identify subtypes in PARDS
次要结局
- Correlation of Nasal and Bronchial Gene Expression(6 years)
- Lung Recovery Gene Expression Profile(6 years)
- Correlation of Endotypes with Lung Cell-specific Biomarkers(6 years)