* 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.
Gestational age ≥34 weeks;
Postnatal age ≤30 days at iNO initiation;
Pulmonary hypertension confirmed by echocardiography (this includes any ultrasound sign or measurement consistent with pulmonary hypertension)
Diagnosis of hypoxic respiratory failure requiring invasive, with any mode (either conventional mechanical ventilation or high-frequency ventilation)
Suspected pulmonary hypoplasia is considered by the investigator to be the primary cause of hypoxemic respiratory failure.
Congenital heart defects (other than a small, hemodynamically insignificant patent ductus arteriosus, or a ventricular septal defect or a patent foramen ovale)
Undergoing or expected to need a combination of other pulmonary vasodilators or surfactants
Methemoglobinemia (MetHb >2.5%) before the onset of iNO treatment
Newborn Babies ≥34 weeks of gestation and postnatal age \<30 days with breathing problems associated with pulmonary hypertension (high blood pressure in the lungs).
Cohort
Prospective
Nitric Oxide Generator and Delivery System
DeviceINOwill N200 is a medical device designed for generation and delivery of inhaled nitric oxide (iNO) for therapeutic use in patients with pulmonary hypertension. The system integrates nitric oxide (NO) gas generation, controlled gas delivery, and real time continuous gas monitoring. It is used in conjunction with ventilatory support. The system delivers inhaled nitric oxide into the patient's breathing circuit in a way that provides a consistent, user-defined concentration to the patient throughout inspiration. It provides continuous monitoring of inspired nitric oxide (NO), nitrogen dioxide (NO2), and oxygen (O2) concentrations, supported by a comprehensive alarm system.
Evaluate the performance of the INOwill-N200 by measuring the proportion of participants achieving a reduction ≥20% in the Oxygenation Index (OI) after 60 minutes of iNO therapy compared to baseline.
OI is calculated as following: OI = (PaO2\*FiO2\*100)/PaO2
To assess the clinical performance of the INOwill-N200 under real-world conditions by measuring the Oxygen Saturation Index (OSI) at predefined time points after baseline.
Description of Oxygen Saturation Index (OSI) during iNO treatment in neonates with PPHN, using continuous oxygenation metrics measured at predefined after baseline (60 min, 6 hours, 12 hours, 24 hours, and daily until treatment discontinuation or at day 14)
To assess the clinical performance of the INOwill-N200 under real-world conditions by measuring the partial pressure of oxygen in arterial blood (PaO₂) at predefined time points after baseline.
Description of the partial pressure of oxygen in arterial blood (PaO₂) during iNO treatment in neonates with PPHN, using continuous oxygenation metrics measured at predefined time points after baseline
To assess the clinical performance of the INOwill-N200 under real-world conditions by measuring the PF ratio (PaO₂/FiO₂) at predefined time points after baseline.
Description of the PF ratio (PaO₂/FiO₂) during iNO treatment in neonates with PPHN, using continuous oxygenation metrics measured at predefined time points after baseline (60 min, 6 hours, 12 hours, 24 hours, and daily until treatment discontinuation or at day 14)
To assess the clinical performance of the INOwill-N200 under real-world conditions by measuring the SF ratio (SpO₂/FiO₂) at predefined time points after baseline.
Description of the SF ratio (SpO₂/FiO₂) during iNO treatment in neonates with PPHN, using continuous oxygenation metrics measured at predefined time points after baseline (60 min, 6 hours, 12 hours, 24 hours, and daily until treatment discontinuation or at day 14)
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Novlead Inc.
Lead sponsor
Medi-Link
Collaborator
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