Observing the use of a Nitric Oxide Generator for newborns with pulmonary hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Closed-loop smart weaning of inhaled nitric oxide for newborns with PPHN

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• Genetic factors and risk of persistent pulmonary hypertension in newborns

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• Dopamine versus norepinephrine for low blood pressure in newborns with pulmonary hypertension

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.