Post Market Clinical Follow-up to Assess the Portable Nitric Oxide Generation and Delivery System (INOwill N200) for the Treatment of Neonatal Hypoxic Respiratory Failure Complicated by Pulmonary Hypertension
brief summary
* 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.
detailed description
This multicenter clinical study will evaluate the INOwill-N200 nitric oxide generation and delivery system in neonates with hypoxic respiratory failure associated with pulmonary hypertension who require inhaled nitric oxide therapy.
Decisions regarding the prescribed iNO concentration, dose adjustment, weaning, interruption, and discontinuation will be made by the treating medical team according to the participant's clinical condition and the study protocol.
Technical performance will be assessed using treatment data including prescribed and delivered NO concentrations, delivered NO₂ and oxygen concentrations, the time required to reach the prescribed NO concentration, the stability of NO delivery, alarms, treatment interruptions, and device or accessory replacements. Where sufficiently detailed timestamped data are available, the percentage of valid monitored treatment time during which NO and NO₂ concentrations remain within the manufacturer-specified performance and safety ranges will be calculated centrally.
Oxygenation and ventilation parameters will be assessed at baseline, 60 minutes, 6 hours, 12 hours, 24 hours, and daily thereafter through Day 14, as applicable. Collected parameters include the Oxygenation Index, Oxygen Saturation Index, PaO₂, SpO₂, FiO₂, PaO₂/FiO₂ ratio, SpO₂/FiO₂ ratio, ventilation mode, and other protocol-defined respiratory parameters. Actual assessment dates and times will be recorded to evaluate compliance with the predefined assessment windows.
Safety surveillance will include adverse events, serious adverse events, device deficiencies, technical malfunctions, alarms, unplanned interruptions of NO delivery, and methemoglobin concentrations. The seriousness, severity, outcome, and relationship of each event to the INOwill-N200, iNO therapy, and study procedures will be assessed as defined in the protocol.
Healthcare professionals will complete the iNO Device Performance Assessment Questionnaire at baseline and on Day 14.
Device-use and healthcare-resource data will be collected to support the medico-economic evaluation. Treatment duration, generator use, accessories, consumables, replacements, staff time, and technical interventions may be combined with predefined unit costs to estimate the direct cost of iNO treatment per participant and the cost per treatment day.
official 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