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

Recruiting

• Conditions: Pulmonary Hypertension of Newborn
• Interventions: Device: Nitric Oxide Generator and Delivery System

• Registration Number: NCT05703191
• Lead Sponsor: Novlead Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-27
• Study Start: 2023-02-03
• Status Verified: 2024-12
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-03-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nitric Oxide	Nitric Oxide Generator and Delivery System	Inhaled Nitric Oxide

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Oxygenation Index (OI)	Baseline, Minutes 45	OI = Mean Airway Pressure (MPAW)×100×Fraction of Inspiration Oxygen (FiO2)/Partial Pressure of Oxygen (PaO2)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ZhuJiang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangzhou, China