Observing the use of a Nitric Oxide Generator for newborns with pulmonary hypertension
The Efficacy and Safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn: A Non-interventional, Observational, Real-world Study
Novlead Inc. · NCT05703191
This study is testing if a special device that delivers nitric oxide can help newborns with pulmonary hypertension breathe better and improve their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Sex | All |
| Sponsor | Novlead Inc. (industry) |
| Locations | 1 site (Guangzhou, Guangzhou) |
| Trial ID | NCT05703191 on ClinicalTrials.gov |
What this trial studies
This study aims to observe the efficacy and safety of a Nitric Oxide Generator and Delivery System in treating newborns diagnosed with pulmonary hypertension in real-world clinical settings. It involves monitoring patients who are clinically considered to benefit from inhaled nitric oxide and have been admitted to the Department of Neonatology. The study will collect data on the treatment's impact on oxygenation and overall health outcomes in these infants.
Who should consider this trial
Good fit: Ideal candidates include newborns diagnosed with pulmonary hypertension who require respiratory support and are considered suitable for inhaled nitric oxide treatment.
Not a fit: Patients who have contraindications to nitric oxide or are expected to require other pulmonary vasodilators or treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment options and outcomes for newborns suffering from pulmonary hypertension.
How similar studies have performed: While this approach is being observed in a real-world setting, similar studies have shown promise in the use of inhaled nitric oxide for pulmonary hypertension in newborns.
Eligibility criteria
Show full 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. 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
Where this trial is running
Guangzhou, Guangzhou
- ZhuJiang Hospital of Southern Medical University — Guangzhou, Guangzhou, China (RECRUITING)
Study contacts
- Principal investigator: Bin Wang — Southern Medical University, China
- Study coordinator: Zhou Fang
- Email: zhou.fang@novlead.com
- Phone: +8615655595707
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pulmonary Hypertension of Newborn