A Real-world Study of Nitric Oxide Generator and Delivery System
ConditionPulmonary Hypertension of Newborn
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorNovlead Inc.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Nitric Oxide Generator and Delivery System
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov