A Real-world Study of Nitric Oxide Generator and Delivery System
Recruiting · NCT05703191 · Observational (researchers observe without assigning treatment) · Lead sponsor: Novlead Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Nitric Oxide Generator and Delivery System
What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
1 location listed.
- ZhuJiang Hospital of Southern Medical University - Guangzhou, Guangzhou, China