Clinical trials

* Title : A multicenter clinical trial of the portable nitric oxide generation and delivery system (INOwill N200) for the treatment of neonatal hypoxic respiratory failure complicated by pulmonary hypertension * Investigational product :Device Name: Nitric Oxide Generator and Delivery System * Study population : Newborn Babies ≥34 weeks of gestation and postnatal age \<30 days with breathing problems associated with pulmonary hypertension (high blood pressure in the lungs). The goal of this prospective, multicenter, single-arm, post-market clinical study is to evaluate the performance, safety, usability, and medico-economic aspects of the INOwill-N200 device when used to deliver inhaled nitric oxide (iNO) to neonates requiring iNO therapy as part of their clinical care. The main questions this study aims to answer are: * Can the INOwill-N200 deliver the prescribed NO concentration and maintain delivered NO and NO₂ concentrations within the manufacturer-specified performance and safety ranges? * Does oxygenation improve 60 minutes after initiation of iNO therapy compared with baseline, as assessed by changes in the Oxygenation Index and arterial oxygen partial pressure? * What adverse events, serious adverse events, device deficiencies, alarms, or interruptions occur during treatment? * How do healthcare professionals assess the performance and usability of the device? * What are the total cost per participant and the cost per day of iNO therapy using the INOwill-N200? There is no comparison group in this study. The decision to initiate, adjust, wean, interrupt, or discontinue iNO therapy will remain under the responsibility of the treating medical team and will be based on each participant's clinical condition. Neonates enrolled in the study will: * Receive prescribed iNO therapy using the INOwill-N200; * Undergo oxygenation and ventilation assessments at baseline, 60 minutes, 6 hours, 24 hours, and at the end of iNO treatment, as specified in the protocol; * Have delivered NO, NO₂, and oxygen concentrations monitored during treatment; * Have methemoglobin levels monitored according to the study protocol; * Be monitored for adverse events, serious adverse events, device deficiencies, alarms, and treatment interruptions; * Be followed until the end of study participation, for up to 14 days. Healthcare professionals using the INOwill-N200 will complete the iNO Device Performance Assessment Questionnaire to evaluate device performance, usability, and overall satisfaction. Device use and healthcare resource consumption will also be collected to estimate the total cost of iNO treatment per participant and the cost per day of therapy.

This clinical trial aims to assess the impact on exercise tolerance and the safety of inhaled nitric oxide in subjects with moderate-to-severe COPD. The findings are expected to contribute to the development of safe and effective therapeutic strategies for COPD management.

High Altitude Pulmonary Edema (HAPE) is a critical, non-cardiogenic pulmonary edema that manifests in high-altitude conditions, marked by the rapid onset of symptoms such as dyspnea, cough, frothy sputum, and cyanosis. It represents a significant cause of mortality among high-altitude illnesses due to its swift progression and elevated fatality rates if not addressed promptly. The pathophysiological mechanisms underlying HAPE include excessive hypoxic pulmonary vasoconstriction, increased permeability of the pulmonary vasculature, impaired clearance of fluid from the lungs, and systemic fluid retention. A pivotal factor in HAPE is pulmonary arterial hypertension (PAH), characterized by a progressive rise in pulmonary arterial pressure and resistance, which can ultimately lead to right heart failure. Recent developments in the management of HAPE have introduced inhaled nitric oxide (iNO) as a selective pulmonary vasodilator, which effectively lowers pulmonary arterial pressure and enhances oxygenation without inducing systemic hypotension. The INOwill N300 device, created by Nanjing Novlead Biotech, is a portable iNO delivery system that produces nitric oxide gas on-site, thereby obviating the need for gas cylinders. This device also facilitates real-time monitoring of nitric oxide, nitrogen dioxide, and oxygen concentrations, ensuring safe and effective treatment. This innovative strategy shows potential for improving clinical outcomes in patients with HAPE while addressing logistical challenges encountered in high-altitude environments.

The detection of exhaled nitric oxide (FeNO) represents a non-invasive, safe, and rapid approach for assessing endogenous nitric oxide (NO) levels within the airway. FeNO concentrations are closely associated with airway inflammation and hyperresponsiveness, and are currently recognized as biomarkers indicative of type II airway inflammation. Recent advancements in nitric oxide detection technology for both upper and lower airways, as well as for small and large airways, have provided significant insights for the diagnosis and management of conditions such as bronchial asthma, chronic cough, upper airway diseases, chronic obstructive pulmonary disease, and even rare airway disorders. Presently, FeNO measurement is frequently employed in the differential diagnosis and monitoring of airway inflammatory diseases. The FeNO test is conducted using a FeNO test analyzer. Internationally, FeNO detection analyzers utilize three primary methodologies: chemiluminescence, laser, and electrochemical techniques. Among these, chemiluminescence is regarded as the "gold standard" globally. However, due to technical constraints, this methodology has not been clinically accessible within domestic settings. In China, the electrochemical FeNO analyzer is predominantly utilized, characterized by its compact size and portability. Nonetheless, this method necessitates patient cooperation during inhalation and exhalation, rendering it impractical for individuals who are unable to comply, such as children, the elderly, and severely ill patients. Consequently, FeNO detection poses significant challenges for these populations in China, representing a notable clinical gap. The newly implemented technology employs an innovative domestic chemiluminescence FeNO analyzer, which is exclusively available in China. This analyzer, owing to its methodological advantages, is capable of obtaining FeNO detection values from patients' natural breathing patterns, facilitating rapid response and comprehensive FeNO assessment without requiring patient cooperation. This approach, referred to as the "Tidal-breathing of FeNO" enables the completion of FeNO assessments in patients who are unable to engage in inspiratory and expiratory maneuvers. This advancement is anticipated to enhance the diagnostic accuracy of airway inflammation in this demographic, thereby facilitating early diagnosis, precise treatment, and improved management of disease progression.

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.