NCT05703191招募中不适用
The Efficacy and Safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn: A Non-interventional, Observational, Real-world Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Novlead Inc.
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change From Baseline in Oxygenation Index (OI)
研究概览
简要总结
The study is aimed to observe the efficacy and safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn in real clinical settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically considered to benefit from inhaled nitric oxide (iNO) and decided to use Nitric Oxide Generator and Delivery System by clinicians
- •Admitted to the Department of Neonatology at the hospital, gender unlimited
- •Diagnosed as pulmonary hypertension and undergoing/decided to undergo respiratory support
- •Documented Oxygenation index (OI) ≥8 prior to the treatment
- •Signed informed consent by the parent(s) or the legal representative(s) with fully aware of the benefits and risks of this study
排除标准
- •Proven risks of nitric oxide contraindication
- •Undergoing or expected to need a combination of other pulmonary vasodilators, surfactants or extracorporeal membrane oxygenation
- •Other circumstances that investigators believe unsuitable for enrollment
结局指标
主要结局
Change From Baseline in Oxygenation Index (OI)
时间窗: Baseline, Minutes 45
OI = Mean Airway Pressure (MPAW)×100×Fraction of Inspiration Oxygen (FiO2)/Partial Pressure of Oxygen (PaO2)
次要结局
- Percentage of subjects responding to iNO(Hour 24, 2 hours after iNO is discontinued)
- Ventilation and monitoring parameters of Nitric Oxide Generator and Delivery System during treatment(Minutes 45, Hour 24, 2 hours after iNO is discontinued)
- Adverse events(Baseline up to 24 hours after iNO is discontinued)
- Change From Baseline in Oxygen Saturation(Baseline, Hour 24, 2 hours after iNO is discontinued)
- Change From Baseline in Pulmonary Artery Pressure (PAP)(Baseline, Hour 24, 2 hours after iNO is discontinued)
- Change From Baseline in Oxygenation Index (OI)(Baseline, Hour 24, 2 hours after iNO is discontinued)
研究者
研究点 (1)
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