NCT05703191RecruitingNot Applicable
The Efficacy and Safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn: A Non-interventional, Observational, Real-world Study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Novlead Inc.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Oxygenation Index (OI)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change From Baseline in Oxygenation Index (OI)
Time Frame: Baseline, Minutes 45
OI = Mean Airway Pressure (MPAW)×100×Fraction of Inspiration Oxygen (FiO2)/Partial Pressure of Oxygen (PaO2)
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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