An inflatable cap, developed by the research group led by Dr. Renato Rozental, a researcher at the Oswaldo Cruz Foundation (Fiocruz) and the Federal University of Rio de Janeiro (UFRJ), could save the lives of thousands of babies who are experiencing perinatal asphyxia–lack of oxygenation to their brains–and reduce serious neurological after-effects or even prevent them from occurring. The cap is made from two layers of overlaid flexible plastic material, with the edges joined, forming an internal space which, when inflated with carbon dioxide (CO2), adapts to the shape of the newborn’s head, forming a kind of helmet. The objective is to cool the child’s brain, interrupting the abnormal electric activity caused by the lack of oxygen, which can cause irreversible injury or even death.
According to data from the World Health Organization (WHO), published in Neonatal and perinatal mortality: Country, regional and global estimates, in 2006, the estimated death rate from asphyxia in babies in developing countries is seven per thousand births, while the rate for developed countries is less than one. Two studies conducted at the beginning of the last decade in Brazil demonstrated the prevalence of asphyxia in newborns. Jorge Rezende Filho, professor of obstetrics at UFRJ, recalls a study from 2003 conducted for a doctoral dissertation that was defended at Fiocruz. “At that time, the number of cases of perinatal asphyxia in Brazil not necessarily leading to death, was 2.1%, or 21 cases per thousand births,” he says. Another study, conducted by researchers at the University of São Paulo School of Medicine (FM-USP), published in the journal Revista Brasileira de Crescimento e Desenvolvimento Humano, and coordinated by Dr. Maria Esther Jurfest Rivero Ceccon, head of Neonatal Intensive Care Center 2 of the Children’s Institute of Hospital das Clínicas (HC) at USP, demonstrated an overall prevalence of asphyxia in newborns of 3.2 per thousand births during the period from January 2004 to January 2005 at the Neonatal Unit of Hospital Santa Marcelina, located in the district of Itaim Paulista, in the city of São Paulo.
There are several factors that can lead to asphyxia in babies during pregnancy or at birth, according to Rozental, a researcher at the Fiocruz Center for Technological Development in Health (CDTS) and professor of neurophysiology at UFRJ. Among the most common causes are strangulation caused by the umbilical cord wrapped around the baby’s neck, known as a nuchal cord. “This can also be caused by placental abruption, a problem that sometimes occurs during pregnancy,” he adds. “Asphyxia can also be caused by trauma during birth.”
Whatever the cause, the result is a drop in the brain’s oxygenation level. This situation is a medical emergency, because some areas of encephalitic tissue, which varies from case to case, become more susceptible to injury. “If we do not act quickly, irreparable neurological damage can occur,” explains Rozental. “There is a critical period, the therapeutic window, no longer than four hours, in which the newborn must receive treatment.” In addition to medication, the standard procedure for many years has been therapeutic hypothermia, in which the brain temperature must be reduced to interrupt the abnormal electrical activity that occurs when the brain is not receiving the oxygen it needs.
Dr. Ceccon explains that all newborns with asphyxia should be cooled immediately after birth and remain that way for 72 hours. “Cooling slows down metabolism in the brain, preventing or minimizing injury,” she says. “At the same time as the baby is being cooled, it is given phenobarbital, a medication that prevents convulsions and can regenerate some brain tissue injured by asphyxia.” The problem is that cooling can only be done by using machinery and equipment that is more commonly found in large hospitals. “In addition, even at major care centers, hypothermia is applied to the entire body, since there is no equipment that exists to cool only the head,” explains Rozental. “The risk is that this procedure to lower the newborn’s body temperature can cause cardiac arrhythmia, which can be fatal for the baby.” For this reason, Rozental and his team are looking for a solution to be used in small towns and other distant locations, which lack adequate hospital care, that could cool only the brain and thus gain time so that the baby can be transported to a better equipped medical center. The flexible helmet is inflated with carbon dioxide, an easily obtained and inexpensive gas used in hospitals, mixed with oxygen.
Prototype and award
Rozental says that he got idea to develop this device about 15 years ago, when he was a professor at the Albert Einstein College of Medicine, in the United States. “Since then, my work has consisted of developing therapeutic strategies or equipment to treat low oxygenation, blood flow deficiencies and central nervous system trauma,” he explains. But it was not until July 2015, when he received funding from the Brazilian Ministry of Health, and later from the Rio de Janeiro State Research Foundation (Faperj), that he was able to create the first prototype. One lot of these prototypes is scheduled to be used in tests with patients in 2017. The objective is to obtain approval from the National Sanitary Surveillance Agency (Anvisa) so that the cap can be used in the public health system within two years.
The cap should have a low production cost. “The price of the hypothermia machines used in hospitals ranges from $5,000 to $30,000,” notes Rozental. “Initially, our helmet will cost between R$600 and R$700, a price that is expected to fall in two years to somewhere between R$200 and R$300, depending on the scale of production. If the product is adopted on a large scale within the Unified Health System (SUS), our expectation is for this price to fall even further.” The cap created by Rozental received the popular vote award in 2016 from the “Saving Lives at Birth” consortium, composed of the Bill & Melinda Gates Foundation, the World Bank and government entities of the United States, Norway, the United Kingdom and South Korea. “The design was conceptualized as one of radical innovation, since there was nothing like it on the market. It was one of the 49 designs selected from among 750 entries from 78 countries and it received the diploma confirming scientific recognition by the consortium.”
Some prototype helmets are being developed at the I Vital Brazil Institute (IVB), in Niteroi, of the Rio de Janeiro state government. After its functionality and efficiency have been proven, the device will be commercially produced by a company. “We still have about a year ahead of us to finalize and perfect the ideal functional prototype,” says Rozental. “During this period, we will be selecting the company that will manufacture them on a large scale.”
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