A Real-world Study of Nitric Oxide Generator and Delivery System

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.

Official Title
-----------------
The Efficacy and Safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn: A Non-interventional, Observational, Real-world Study

Conditions
-----------------
Pulmonary Hypertension of Newborn

Intervention / Treatment
-----------------
* Device: Nitric Oxide Generator and Delivery System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically considered to benefit from inhaled nitric oxide (iNO) and decided to use Nitric Oxide Generator and Delivery System by clinicians Term and near term newborns (at least 34 gestational weeks), gender unlimited Diagnosed as pulmonary hypertension and undergoing/decided to undergo respiratory support Documented Oxygenation index (OI) ≥16 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

Ages Eligible for Study
-----------------
Minimum Age: 34 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nitric Oxide<br>Inhaled Nitric Oxide | Device: Nitric Oxide Generator and Delivery System<br>* Initial at 20ppm is recommended by guidelines. The concentration is adjusted based on actual condition of subjects.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Oxygenation Index (OI) | OI = Mean Airway Pressure (MPAW)×100×Fraction of Inspiration Oxygen (FiO2)/Partial Pressure of Oxygen (PaO2) | Baseline, Minutes 45 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Oxygenation Index (OI) | OI = MPAW×100×FiO2/PaO2 | Baseline, Hour 24, 2 hours after iNO is discontinued | 
| Change From Baseline in Oxygen Saturation | Oxygen Saturation: Peripheral Capillary Oxygen Saturation (SpO2) | Baseline, Hour 24, 2 hours after iNO is discontinued | 
| Change From Baseline in Pulmonary Artery Pressure (PAP) | Doppler echocardiography is used to detect the regurgitation velocity, and tricuspid regurgitation V values are derived. PAP = 4 × V2 + 5 mmHg. | Baseline, Hour 24, 2 hours after iNO is discontinued | 
| Percentage of subjects responding to iNO | Responding to iNO is defined as a decrease in OI of 25% or more | Hour 24, 2 hours after iNO is discontinued | 
| Ventilation and monitoring parameters of Nitric Oxide Generator and Delivery System during treatment | Parameters detected by Nitric Oxide Generator and Delivery System | Minutes 45, Hour 24, 2 hours after iNO is discontinued | 
| Adverse events | Incidence of adverse events=Number of subjects with adverse events/Total number of subjects in treatment | Baseline up to 24 hours after iNO is discontinued |