NCT05703191 A Real-world Study of Nitric Oxide Generator and Delivery System
| NCT ID | NCT05703191 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novlead Inc. |
| Condition | Pulmonary Hypertension of Newborn |
| Study Type | OBSERVATIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-02-03 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10 participants in total. It began in 2023-02-03 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Bin Wang
PRINCIPAL INVESTIGATOR
Southern Medical University, China
Frequently Asked Questions
Who can join the NCT05703191 clinical trial?
This trial is open to participants of all sexes, studying Pulmonary Hypertension of Newborn. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05703191 currently recruiting?
Yes, NCT05703191 is actively recruiting participants. Contact the research team at zhou.fang@novlead.com for enrollment information.
Where is the NCT05703191 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05703191 clinical trial?
NCT05703191 is sponsored by Novlead Inc.. The principal investigator is Bin Wang at Southern Medical University, China. The trial plans to enroll 10 participants.