The Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) In Pediatrics
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Mallinckrodt
- 入组人数
- 55
- 试验地点
- 16
- 主要终点
- arterial blood gases
研究概览
简要总结
The purpose of this study is to determine the effect of nitric oxide for inhalation on the duration of mechanical ventilation in pediatric patients with AHRF.
详细描述
Patients will receive 5-ppm study gas (nitric oxide for inhalation or placebo) until Day 28 or extubation, whichever comes first. The following will be performed / recorded at specified times during the study: arterial blood gases, ventilator settings, methemoglobin, PRISM III score, and patient positioning. Selected centers will also be performing plasma cytokine assays, broncho-alveolar lavage fluid assays and a 6 month follow-up assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 16 Years（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
研究组 & 干预措施
2
Nitrogen gas
干预措施: Nitrogen gas (Drug)
1
Inhaled Nitric Oxide
干预措施: inhaled nitric oxide (Drug)
结局指标
主要结局
arterial blood gases
时间窗: baseline through 24 hours and extubation
次要结局
- broncho-alveolar lavage fluid(baseline, 48 hours and day 5)
- Prone position(baseline then daily)
- methemoglobin(baseline, hour 4 and 24 hours)