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

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

Recruiting
34 years and older
All
Phase N/A
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Overview

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

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. Term and near term newborns (at least 34 gestational weeks), gender unlimited
  3. Diagnosed as pulmonary hypertension and undergoing/decided to undergo respiratory support
  4. Documented Oxygenation index (OI) ≥16 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

Study details
    Pulmonary Hypertension of Newborn

NCT05703191

Novlead Inc.

14 October 2025

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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