Persistent Pulmonary Hypertension of the Newborn

* 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.

In contemporary clinical practice concerning the administration of inhaled nitric oxide (iNO) within neonatal intensive care units (NICUs), a stepwise reduction approach is frequently employed in accordance with established neonatal guidelines. Nonetheless, the comparative advantages of a linear reduction strategy-characterized by a gradual decrease in inhalation concentration-over the traditional stepwise method in terms of efficacy and safety have yet to be conclusively established. Furthermore, existing iNO delivery devices necessitate that healthcare professionals manually adjust parameters at intervals dictated by the patient's condition. This reliance on subjective clinical judgment often results in variability and a lack of standardization in the duration of the weaning process. Additionally, the protracted and intricate nature of the weaning procedure considerably heightens the workload for healthcare staff. Importantly, the development of a scientifically grounded, standardized, and real-time feedback mechanism for weaning may enhance clinical outcomes for patients and mitigate the risks associated with inappropriate weaning practices or inconsistent manual interventions. Consequently, this study seeks to leverage the newly introduced "intelligent closed-loop weaning" feature of the latest generation of iNO devices to facilitate automated linear concentration reduction during the weaning process. This innovation aims to alleviate the burden on healthcare personnel while establishing a more standardized and scientifically robust weaning protocol. However, it is noteworthy that there is currently a lack of clinical evidence, both domestically and internationally, regarding the safety and efficacy of this device's weaning protocol, underscoring the urgent need to validate its safety and effectiveness in real-world clinical settings.

The purpose of this study is to determine if normally occurring variations in a specific gene called PTGS-1 are associated with an increased risk of narrowing of the ductus arteriosus from exposure to over-the-counter pain medicines (NSAIDs).