Neonatal Cooling Device for Reducing and Treating Brain Injuries and Neurological Dysfunction Caused by Asphyxia in Newborns

The neonatal cooling device is used to reduce and treat brain injuries and neurological dysfunctions caused by asphyxia (suffocation or lack of oxygen) in newborns. Without treatment, newborns with asphyxia can suffer severe complications, including brain damage, epilepsy, cerebral palsy, and even death.

While the incidence of this condition in developed countries is between 1 to 3 cases per 1,000 live births, in low- and middle-income countries, it ranges from 7 to 20 cases per 1,000 live births, resulting in the annual death of 840,000 newborns worldwide. If perinatal hypoxic brain injury in newborns is not treated, 62% of them either die or suffer from moderate to severe disabilities such as cerebral palsy or developmental delays like mental retardation by the age of 18 to 22 months. According to the Neonatal Health Department’s report, in the four years leading up to mid-2021, there were 7,920 cases of asphyxia in Iran, with 36% (2,812 cases) diagnosed as moderate to severe asphyxia. These cases could have benefited from this treatment, as surviving newborns suffer severe complications, imposing significant lifelong costs on the healthcare system and their families. Notably, with increasing maternal age, the birth of third and fourth children, and the rise in natural deliveries, the incidence of neonatal asphyxia has significantly increased, necessitating attention to managing these potential complications.

Currently, out of more than 300 active neonatal intensive care units (NICUs) in the country, fewer than 10 NICUs have neonatal cooling devices for providing hypothermia therapy to asphyxiated newborns. The production of this device is currently limited to manufacturers from the UK, the USA, and Israel, with a few UK-made units imported before the sanctions. However, we have successfully produced this product for the first time in Iran and the Middle East, making the country self-sufficient in this regard. The product manufactured by our company is fully competitive with foreign products in terms of quality and costs less than half the price of foreign models.

Given the overall policies for the health of newborns in this country and the provision of cooling therapy as the only effective treatment for this condition, various healthcare centers have expressed interest in purchasing this product. So far, healthcare centers such as Omolbanin Hospital in Mashhad, Ali Ibn Abi Talib Hospital in Zahedan, Iranshahr Hospital in Sistan and Baluchestan, and Sayyad Shirazi Hospital in Gorgan have acquired this device.