NCT05703191Recruiting
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
Source: ClinicalTrials.gov · Last updated 19 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 10 (estimated)
- First submitted
- 6 Jan 2023
- Start date
- 3 Feb 2023
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- Novlead Inc.
- NCT number
- NCT05703191
What you commit to
- Study type: Observational
- Planned participants: 10
- From 3 Feb 2023 to the primary completion date, 31 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhujiang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.