跳至主要内容
临床试验/NCT05703191
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

Novlead Inc.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年2月3日最近更新:
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

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

发起方
Novlead Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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