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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	34 Weeks and Over
Gender	All

More Inclusion & Exclusion Criteria

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. Term and near term newborns (at least 34 gestational weeks), gender unlimited. 3. Diagnosed as pulmonary hypertension and undergoing/decided to undergo respiratory support. 4. Documented Oxygenation index (OI) ≥16 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05703191
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novlead Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Hypertension of Newborn

Arms & Interventions

Arms

: Nitric Oxide

Inhaled Nitric Oxide

Interventions

Device: - Nitric Oxide Generator and Delivery System

Initial at 20ppm is recommended by guidelines. The concentration is adjusted based on actual condition of subjects.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.