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

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

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 Overview

• Status: Recruiting
• Conditions: Pulmonary Hypertension of Newborn
• Intervention / Treatment: Device: Nitric Oxide Generator and Delivery System

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Zhou Fang; Phone Number: +8615655595707; Email: zhou.fang@novlead.com

Study Locations

• China
  • Guangzhou
    • Guangzhou, Guangzhou, China
      • Recruiting
      • Zhujiang Hospital of Southern Medical University
      • Contact: Bin Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Newborns

Description

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. Admitted to the Department of Neonatology at the hospital, gender unlimited
3. Diagnosed as pulmonary hypertension and undergoing/decided to undergo respiratory support
4. Documented Oxygenation index (OI) ≥8 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nitric Oxide; Inhaled Nitric Oxide	Device: Nitric Oxide Generator and Delivery System; Initial at 20ppm is recommended by guidelines. The concentration is adjusted based on actual condition of subjects.

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

Collaborators and Investigators

• Sponsor: Novlead Inc.
• Investigators: Principal Investigator: Bin Wang, Southern Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2023
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Antioxidants; Protective Agents; Respiratory System Agents; Free Radical Scavengers; Anti-Asthmatic Agents; Bronchodilator Agents; Vasodilator Agents; Endothelium-Dependent Relaxing Factors; Gasotransmitters; Nitric Oxide
• Other Study ID Numbers: PAH22-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No