Linking Endotypes and Outcomes in Pediatric Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 513
- 试验地点
- 25
- 主要终点
- 28 Day Mortality in Pediatric ARDS.
研究概览
简要总结
The overall goal of the study is to risk stratify pediatric Acute Respiratory Distress Syndrome (ARDS) patients and to identify sub-phenotypes with shared biology in order to appropriately target therapies in future trials. This is a prospective, multicenter study of 500 intubated children with ARDS, with planned blood collection within 24 hours of ARDS onset and subsequent measurement of plasma protein biomarkers and peripheral blood gene expression.
详细描述
Investigators will measure pre-determined biomarkers with known or suspected association with ARDS severity or outcome. Simultaneously, investigators will measure gene expression of peripheral blood. Both plasma biomarkers and gene expression profiles will be analyzed using various machine learning techniques, including classification and regression tree, latent class analysis, and hierarchical clustering with the goal of identifying sub-phenotypes of ARDS. These sub-phenotypes will be examined for association with outcome (primary is 28-day mortality), and explicitly tested for variation in response to exogenous treatments (e.g., corticosteroids).
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
- 44 Weeks 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute (≤ 7 days of risk factor) respiratory failure requiring invasive mechanical ventilation
- •age > 44 weeks corrected gestational age and < 17.5 years
- •invasive mechanical ventilation via endotracheal tube
- •bilateral infiltrates on chest radiograph
- •oxygenation index (OI) ≥ 4; or oxygen saturation index (OSI) ≥ 5 on 2 consecutive measurements at least 4 hours apart but < 24 hours apart
- •invasively ventilated ≤ 7 days before meeting above radiographic and oxygenation criteria
排除标准
- •weight < 3 kilograms
- •cyanotic congenital heart disease (other than Patent Foramen Ovale (PFO) or Patent Ductus Arteriosus (PDA))
- •tracheostomy at time of screening
- •invasively ventilated for > 7 days when meet ARDS criteria above
- •cardiac failure as predominant cause of respiratory failure
- •primary obstructive airway disease (asthma, bronchiolitis) by judgement of clinician as the primary cause of respiratory failure
- •alternative known chronic lung disease as cause of respiratory failure (cystic fibrosis, eosinophilic pneumonia, interstitial pneumonitis, pulmonary hemosiderosis, cryptogenic organizing pneumonia)
- •severe neurologic morbidity not expected to survive > 72 hours
- •any limitations of care at time of screening
- •previous enrollment in this study
结局指标
主要结局
28 Day Mortality in Pediatric ARDS.
时间窗: 28 days
28 day all cause mortality.
Presence of two or more endotypes in Pediatric ARDS.
时间窗: Within 24 hours of ARDS onset
Stratify pediatric ARDS into sub-phenotypes using a known 100-gene expression-based classifier to group subjects according to shared underlying biology.
Occurrence of de novo sub-phenotypes in pediatric ARDS using biomarkers and whole genome transcriptomics of peripheral blood.
时间窗: Within 24 hours of ARDS onset.
Occurrence of de novo sub-phenotypes in pediatric ARDS using 12 protein biomarkers and whole genome transcriptomics of peripheral blood.
Presence of Two or More Endotypes in Pediatric ARDS.
时间窗: Within 24 hours of ARDS onset
Stratify pediatric ARDS into sub-phenotypes using a known 100-gene expression-based classifier to group subjects according to shared underlying biology.
Occurrence of de Novo Sub-phenotypes in Pediatric ARDS Using Biomarkers and Whole Genome Transcriptomics of Peripheral Blood.
时间窗: Within 24 hours of ARDS onset.
Occurrence of de novo sub-phenotypes in pediatric ARDS using 12 protein biomarkers and whole genome transcriptomics of peripheral blood.
次要结局
- ventilator-free days at 28 days.(28 days)
- Ventilator-free Days at 28 Days.(28 days)