Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Mallinckrodt
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- PaO2 level
研究概览
简要总结
The purpose of this pilot study is to evaluate whether administration of nitric oxide (NO)gas by oxygen hood at 20 ppm significantly increases PaO2, as compared to placebo gas (oxygen), within one hour of initiation and with no significant adverse effects.
详细描述
It is possible that administration of inhaled NO to neonates with abnormal gas exchange earlier, rather than later as a rescue therapy in a moribund state, might accelerate the transition of the circulation from the fetal to neonatal physiology and improve oxygenation. This may in turn decrease the need for mechanical ventilation, its associated morbidity and perhaps even ECMO.
This study is designed as a pilot study to evaluate the physiologic efficacy (rather than effect on clinical outcomes) of NO administered by hood in improving oxygenation of neonates with elevated A-a DO2.
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 120 Hours（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
1
Nitric Oxide for Inhalation
干预措施: nitric oxide for inhalation (Drug)
2
oxygen
干预措施: Oxygen (Drug)
结局指标
主要结局
PaO2 level
时间窗: at baseline, then every hour for 6 hours
次要结局
- Alveolar-arterial oxygen gradient and ratio(after 1 hour of treatment)
- Methemoglobin level(at baseline then every hour of treatment)