Safety of a novel portable inhaled nitric oxide generator for therapy of persistent pulmonary hypertension in neonates: a case series study.

Background: Persistent pulmonary hypertension of the newborn (PPHN) is a life-threatening emergency in neonatal intensive care. Traditional treatments such as cylinder-based nitric oxide (NO) delivery systems rely on large, fixed equipment, creating limitations during neonatal transport or treatment in primary hospitals, which may delay critical intervention. Moreover, neonates exhibit high physiological vulnerability, imposing stricter requirements on the safety and portability of therapeutic devices. Novlead Biotech in China has developed a novel portable inhaled nitric oxide (iNO) generator (PG-iNO), which shows promise in overcoming these obstacles. This study aims to assess the safety of PG-iNO for the treatment of PPHN using a descriptive study. Methods: The data of seven newborns diagnosed with PPHN and having received PG-iNO from December 1, 2023 to January 31, 2024 were retrieved from medical records. Demographic and clinical features, vital signs, arterial blood gas, ventilation indicators, measurement of preductal and postductal oxygen saturation, mortality, and comorbidities were evaluated before and after the administration of PG-iNO therapy. Results: All enrolled patients survived and reported few side effects during the administration of PG-iNO. A significant improvement in oxygenation index (OI), fraction of inspired oxygen (FiO2), mean airway pressure (MAPaw), and arterial partial pressure of oxygen (PaO2) was observed before and 48 hours after initiating PG-iNO therapy. Conclusions: The PG-iNO demonstrates safety in the treatment of neonatal PPHN. However, large-scale, prospective trials are needed to further validate its long-term safety and efficacy, particularly in preterm infants.