Introduction
Preterm birth rates continue to rise globally, prompting healthcare providers to seek ways to improve care for this vulnerable patient group. From the United States with a rate of 10.5%1, to Europe and other developed countries with 5-11%2, the medical care of preterm born infants presents unique challenges and requires specialized methods of diagnosis and treatment. As their lungs are not fully developed, pulmonary disorders, such as respiratory distress syndrome, pneumothorax, and atelectasis, are common in these neonates and require prompt detection, diagnosis, and treatment to improve patient outcomes. This is where Neola® comes in as a potential game-changer in the Neonatal Intensive Care Unit (NICU), offering a non-invasive, and continuous monitoring of the lungs of neonates. Based on cutting-edge optical technology, Gas-in-scattering-media absorption spectroscopy (GASMAS), variations in the lung volume and free oxygen gas concentration in the patient’s lungs are detected instantaneously. This provides effective lung monitoring for early detection of, possibly life-threatening or irreversible, pulmonary disorders, allowing treatment to start promptly. By bringing this medical device to the market, Neola Medical aims to save more lives, reduce the need for extensive hospitalization, and improve the quality of life for millions of preterm born babies.
Background
Every year, medical practitioners and researchers search for new ways to save the life of preterm born infants and to decrease the number of individuals with major disabilities in adult life resulting from preterm birth. The most common ailments that affect preterm born infants are pulmonary disorders including bronchopulmonary dysplasia (BPD) and respiratory distress syndrome (RDS). The incidence of BPD remains high and has been mostly unchanged during the last decade, ranging from 20% in California to 28% across the U.S., and 42% among infants less than 28 weeks’ gestation3. RDS is one of the most common reasons an infant is admitted to the neonatal intensive care unit. Fifteen percent of term infants and 29% of late preterm born infants admitted to the neonatal intensive care unit develop significant respiratory morbidity. Respiratory problems are typically accompanied by hypoxia affecting all organs and systems. Respiratory distress can escalate to respiratory failure and cardiopulmonary arrest4. RDS can cause hypoxemia through alveolar hyperventilation, diffusion abnormality, ventilation-perfusion mismatch, intrapulmonary shunting, or a combination of these mechanisms. This hypoxemia and tissue hypoperfusion ultimately lead to increased anaerobic metabolism at a cellular level with resultant lactic acidemia5.
Due to environmental stress factors, preterm born infants can experience inadequate oxygenation, intraventricular hemorrhage, and periventricular leukomalacia which occur much more frequentlycompared to their term counterparts6. Once these children reach school age, other cognitive impairments including learning disabilities and behavioral problems are more frequently observed.
The patient group described above is large. In 2021, preterm birth affected 1 of every 10 infants born in the United States, or approximately 385,000 infants. The U.S. preterm birth rate rose 4% in 2021 to 10.49%, the highest level reported since at least 20071. Preterm birth is defined as a birth that occurs before the start of the 37th week of pregnancy. These infants deserve a complete life without limitations, whether physical or mental. Therefore, innovative solutions are needed to address the challenges of preterm birth and help improve the long-term outcomes of affected infants.
