RecruitingNCT05703191

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


Sponsor

Novlead Inc.

Enrollment

10 participants

Start Date

Feb 3, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is tracking real-world use of an inhaled nitric oxide delivery device in newborns with high blood pressure in the lungs (pulmonary hypertension). Nitric oxide gas is inhaled to help relax and open blood vessels in the lungs, making it easier for babies to breathe. **You may be eligible if...** - Your baby is admitted to a neonatal unit - Your baby has been diagnosed with pulmonary hypertension (high blood pressure in the lungs) - The clinical team has decided inhaled nitric oxide is appropriate for your baby - Your baby requires breathing support and has documented low oxygen levels - You (as parent or legal guardian) can give informed consent **You may NOT be eligible if...** - There are known medical reasons why nitric oxide would be unsafe for your baby - Your baby is also being treated with other pulmonary vasodilators, surfactant therapy, or ECMO (a type of heart-lung bypass) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENitric Oxide Generator and Delivery System

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


Locations(1)

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangzhou, China

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NCT05703191