A Real-world Study of Nitric Oxide Generator and Delivery System
Recruiting now
Conditions studied: Pulmonary Hypertension of Newborn
In brief
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.
Key facts
- Study ID
- NCT05703191
- Run by
- Novlead Inc.
- People needed
- 10
- Starts
- 2023-02-03
- Expected to finish
- 2025-05-31
- Last updated by the study team
- 2025-02-19
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- ZhuJiang Hospital of Southern Medical University — Guangzhou, Guangzhou, China (enrolling)
Full record on ClinicalTrials.gov
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