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
Inclusion Criteria5
- 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 Criteria3
- 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
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05703191