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Search / Trial NCT05703191

A Real-world Study of Nitric Oxide Generator and Delivery System

Launched by NOVLEAD INC. · Jan 19, 2023

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special device called the Nitric Oxide Generator and Delivery System to treat newborns with pulmonary hypertension, a serious condition affecting their lungs and heart. The goal is to see how effective and safe this system is when used in real-life hospital settings. The study is currently recruiting participants, which means they are looking for families who are willing to take part.

To be eligible for the trial, newborns must be at least 34 weeks old and have a diagnosis of pulmonary hypertension, meaning their lungs aren't getting enough oxygen. They also need to show a specific level of oxygenation before starting the treatment. Parents or guardians will need to provide consent, meaning they agree to the study after understanding its potential benefits and risks. If selected, participants will receive treatment using the nitric oxide system, and the study team will monitor their progress closely throughout the trial.

Gender

ALL

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

About Novlead Inc.

Novlead Inc. is a pioneering clinical trial sponsor dedicated to advancing innovative therapeutic solutions in the healthcare sector. With a strong emphasis on precision medicine, Novlead focuses on developing and conducting clinical studies that address unmet medical needs across various therapeutic areas. The company leverages cutting-edge technology and a robust network of clinical research sites to ensure the highest standards of patient safety and data integrity. Committed to collaboration and transparency, Novlead Inc. strives to accelerate the drug development process and bring transformative treatments to market efficiently and effectively.

Locations

Guangzhou, Guangdong, China

Guangzhou, Guangzhou, China

Patients applied

0 patients applied

Trial Officials

Bin Wang

Principal Investigator

Southern Medical University, China

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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