The Efficacy and Safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn: A Non-interventional, Observational, Real-world Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
ZhuJiang Hospital of Southern Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Zhou Fang
zhou.fang@novlead.com
+8615655595707
Time Frame
Start Date: 2023-02-03
Estimated Completion Date: 2025-05-31
Participants
Target number of participants: 10
Treatments
Nitric Oxide
Inhaled Nitric Oxide
Related Therapeutic Areas
Sponsors
Leads: Novlead Inc.