Safety of a Novel Portable Inhaled Nitric Oxide Generator for Therapy of Persistent Pulmonary Hypertension in Neonates - Case Series Study

Sep 29, 2026

Persistent pulmonary hypertension of the newborn (PPHN) is a life-threatening neonatal emergency, and conventional cylinder-based nitric oxide delivery systems are bulky and costly, limiting timely use during transport or in primary hospitals. A novel portable inhaled nitric oxide generator (PG-iNO) was evaluated in seven PPHN newborns treated between Dec 1, 2023 and Jan 31, 2024. Demographics, clinical features, vital signs, blood gases, oxygen saturation, mortality, and comorbidities were assessed before and after PG-iNO. All infants survived, few side effects occurred, and oxygenation improved within 48 hours, with further large prospective multicenter studies needed.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages13

Reading Time33 min

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Background

Methods

Results

Conclusions

Key findings

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Safety of a novel portable inhaled nitric oxide generator for therapy of persistent pulmonary hypertension in neonates: a case series study Yao Zhu1, Jiongzhi He1, Miner Cai2, Lijun Wen1, Minxu Li1^ 1Department of Neonatology, Dongguan Maternal and Child Health Care Hospital, Dongguan, China; 2Department of Neonatology and Pediatrics, The First Affiliated Hospital of Jinan University, Jinan University, Guangzhou, China Contributions: (I) Conception and design: All authors; (II) Administrative support: None; (III) Provision of study materials or patients: Y Zhu, J He, M Cai, L Wen; (IV) Collection and assembly of data: Y Zhu, J He, L Wen; (V) Data analysis and interpretation: Y Zhu; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors. Correspondence to: Prof. Minxu Li, M.Med. Department of Neonatology, Dongguan Maternal and Child Health Care Hospital, No. 99, Zhenxing Road, Dongcheng, Dongguan 523000, [China. Email: neominxu@gdmu.edu.cn](China. Email: neominxu@gdmu.edu.cn). 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, largescale, prospective trials are needed to further validate its long-term safety and efficacy, particularly in preterm infants. Keywords: Persistent pulmonary hypertension of the newborn (PPHN); portable inhaled nitric oxide generator (PG-iNO); nitric oxide (NO); case series Submitted Aug 10, 2025. Accepted for publication Nov 10, 2025. Published online Dec 26, 2025. doi: 10.21037/tp-2025-535 View this article at: [https://dx.doi.org/10.21037/tp-2025-535](https://dx.doi.org/10.21037/tp-2025-535) ^ ORCID: 0009-0001-3269-6917. © AME Publishing Company. Transl Pediatr 2025;14(12):3305-3317 | [https://dx.doi.org/10.21037/tp-2025-535](https://dx.doi.org/10.21037/tp-2025-535) 3306 Zhu et al. Safety of portable no generator for PPHN therapy Introduction Persistent pulmonary hypertension of the newborn (PPHN) is a complex vascular disorder that presents a serious threat to neonates, characterized by elevated pulmonary vascular resistance (PVR) and shunting of oxygen-poor blood from the lungs to the systemic circulation, resulting in profound hypoxemia (1,2) . The reported incidence rate of PPHNis estimated at 1.9 cases per 1,000 live births (2) . Most infants with PPHN are born at term or near term, however approximately 2% are delivered preterm (3) . Inhaled nitric oxide (iNO) is a potent vasodilator originating fr

FAQs

What problem does the portable PG-iNO address in PPHN treatment?

Conventional cylinder-based nitric oxide systems are large and logistically challenging, which can delay critical treatment during transport or in primary hospitals. PG-iNO is designed to overcome these limitations with portable delivery.

How was PG-iNO safety assessed in this study?

Seven newborns with PPHN who received PG-iNO between Dec 1, 2023 and Jan 31, 2024 were reviewed. Side effects, survival, vital signs, arterial blood gases, ventilation indicators, oxygen saturation, mortality, and comorbidities were evaluated before and after administration.

What were the main outcomes after initiating PG-iNO therapy?

All enrolled patients survived and reported few side effects during treatment. Oxygenation measures including oxygenation index, FiO2, mean airway pressure, and PaO2 showed significant improvement from baseline to 48 hours after starting PG-iNO.

Sep 29, 2026

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