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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitric Oxide | Inhaled Nitric Oxide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitric Oxide Generator and Delivery System | Device | Initial at 20ppm is recommended by guidelines. The concentration is adjusted based on actual condition of subjects. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Newborns
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhou Fang | Contact | +8615655595707 | zhou.fang@novlead.com |
| Name | Affiliation | Role |
|---|---|---|
| Bin Wang | Southern Medical University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZhuJiang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangzhou | China |
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| 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 |