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

* 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 \

Inclusion Criteria : * 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) * Oxygenation impairment despite optimized respiratory support, defined by at least one of the following: Oxygenation Index (OI) ≥20; FiO₂ requirement ≥0.60 pour avoir preductal SpO₂ \>90%; PaO₂ \2.5%) before the onset of iNO treatment * Need for immediate cardio-pulmonary resuscitation (i.e. terminal conditions) * Any condition that, in the investigator's judgment, makes the infant unsuitable for participation in this clinical trial