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

Pulmonary Hypertension of Newborn Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05703191
• Other study ID #: PAH22-09
• Status: Recruiting
• Start date: February 3, 2023
• Est. completion date: May 31, 2023

Study information

• Verified date: December 2022
• Source: Novlead Inc.
• Contact: Zhou Fang
• Phone: +8615655595707
• Email: zhou.fang[@]novlead.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 34 Weeks and older

Eligibility

Inclusion Criteria:

1. Clinically considered to benefit from inhaled nitric oxide (iNO) and decided to use Nitric Oxide Generator and Delivery System by clinicians

2. Term and near term newborns (at least 34 gestational weeks), gender unlimited

3. Diagnosed as pulmonary hypertension and undergoing/decided to undergo respiratory support

4. Documented Oxygenation index (OI) =16 prior to the treatment

5. 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:

1. Proven risks of nitric oxide contraindication

2. Undergoing or expected to need a combination of other pulmonary vasodilators, surfactants or extracorporeal membrane oxygenation

3. Other circumstances that investigators believe unsuitable for enrollment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension of Newborn

Intervention

Device:
• Nitric Oxide Generator and Delivery System
Initial at 20ppm is recommended by guidelines. The concentration is adjusted based on actual condition of subjects.

Locations

Country	Name	City	State
China	ZhuJiang Hospital of Southern Medical University	Guangzhou	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Novlead Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Oxygenation Index (OI)	OI = MPAW×100×FiO2/PaO2	Baseline, Hour 24, 2 hours after iNO is discontinued
Secondary	Change From Baseline in Oxygen Saturation	Oxygen Saturation: Peripheral Capillary Oxygen Saturation (SpO2)	Baseline, Hour 24, 2 hours after iNO is discontinued
Secondary	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
Secondary	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
Secondary	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
Secondary	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