Nitric Oxide Generator and Delivery System: Initial at 20ppm is recommended by guidelines. The concentration is adjusted based on actual condition of subjects.
Study 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
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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. Admitted to the Department of Neonatology at the hospital, gender unlimited
3. Diagnosed as pulmonary hypertension and undergoing/decided to undergo respiratory support
4. Documented Oxygenation index (OI) ≥8 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
Primary outcome measure(s)
Change From Baseline in Oxygenation Index (OI) — Baseline, Minutes 45 OI = Mean Airway Pressure (MPAW)×100×Fraction of Inspiration Oxygen (FiO2)/Partial Pressure of Oxygen (PaO2)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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