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

NCT05703191 | Recruiting

• 1 other identifier: PAH22-09
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension of Newborn

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change From Baseline in Oxygenation Index (OI)

  Baseline, Hour 24, 2 hours after iNO is discontinued

• Change From Baseline in Oxygen Saturation

  Baseline, Hour 24, 2 hours after iNO is discontinued

• Change From Baseline in Pulmonary Artery Pressure (PAP)

  Baseline, Hour 24, 2 hours after iNO is discontinued

• Percentage of subjects responding to iNO

  Hour 24, 2 hours after iNO is discontinued

• Ventilation and monitoring parameters of Nitric Oxide Generator and Delivery System during treatment

  Minutes 45, Hour 24, 2 hours after iNO is discontinued

Study Arms (1)

Nitric Oxide

Inhaled Nitric Oxide

Device: Nitric Oxide Generator and Delivery System

Interventions

Nitric Oxide Generator and Delivery System DEVICE

Initial at 20ppm is recommended by guidelines. The concentration is adjusted based on actual condition of subjects.

Nitric Oxide

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newborns

You may qualify if:

• Clinically considered to benefit from inhaled nitric oxide (iNO) and decided to use Nitric Oxide Generator and Delivery System by clinicians
• Admitted to the Department of Neonatology at the hospital, gender unlimited
• Diagnosed as pulmonary hypertension and undergoing/decided to undergo respiratory support
• Documented Oxygenation index (OI) ≥8 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novlead Inc.: lead

Study Sites (1)

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangzhou, China

RECRUITING

Study Officials

• Bin Wang

  Southern Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhou Fang

CONTACT

+8615655595707; zhou.fang@novlead.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 27, 2023
• Study Start: February 3, 2023
• Primary Completion: March 31, 2025
• Study Completion: May 31, 2025
• Last Updated: February 19, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)