Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Xenios AG
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Oxygenation Index
研究概览
简要总结
This prospective observational study will evaluate the safety and performance of the MiniLung petite kit in neonatal and pediatric patients with acute respiratory and cardiac failure.
The main question it aims to answer is (study hypotheses):
Veno-venous (VV) and veno-arterial (VA) Extracorporeal Membrane Oxygenation (ECMO) using the MiniLung petite kit is safe and improves gas exchange (oxygenation and CO2 removal) and hemodynamic stabilization in neonatal and pediatric patients with severe acute respiratory and/or cardiopulmonary failure within 24 hours compared to the treatment before VV or VA ECMO initiation and maintain a life-sustaining condition.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 8 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Oxygenation Index
时间窗: Baseline and during the intervention every 24 hours until a maximum of 29 days
Longitudinal assessments of continuous outcomes will be analyzed by treatment day using mixed models for repeated measures (MMRM), with ECMO mode as a fixed factor (except for analyses performed within the subsets defined by ECMO mode) and the baseline value of the primary endpoint (Oxygenation Index) as a covariate. Within-subject differences between baseline and subsequent visits will be tested using contrasts. The comparison between baseline and the first day on ECMO (initial effect) is considered as the primary outcome.
次要结局
- Hemodynamic stabilization(Baseline and during the intervention every 24 hours until a maximum of 29 days)
- Facilitate lung-protective ventilation in patients additionally receiving invasive mechanical ventilation(Baseline and during the intervention every 24 hours until a maximum of 29 days)
- Assessment of the frequency of complications(Baseline and during the intervention every 24 hours until a maximum of 29 days)