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Clinical Trials in China / NCT05703191
Recruiting Observational

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

NCT05703191 · tracked via the Priya Life Science China tracker
Sponsor
Novlead Inc.
Phase
Observational
Started
2023-02-03
Last updated
2025-02-19

Condition(s) studied

Pulmonary Hypertension of Newborn

Investigational drug(s) / intervention(s)

Nitric Oxide Generator and Delivery System

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

Study 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

Sex
ALL
Min age
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
ZhuJiang Hospital of Southern Medical University Guangzhou Guangzhou Recruiting

More Novlead Inc. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05703191 on ClinicalTrials.gov ↗ ← All trials in China