Babies born prematurely, before 37 weeks of pregnancy, are at increased risk of dying in infancy and often suffer from lifelong health problems .
But two novel devices could help reduce this risk: one by improving the way the risk of premature birth is assessed, and the other by offering personalized nutritional counseling for premature babies.
Every year around 500,000 premature babies are born in Europe and the numbers are increasing . This is due to the fact that more women are suffering from obesity and diabetes today, and that women are having babies later, as well as the increase in multiples due to fertility treatments.
These babies are at a higher risk of developing short-term and long-term health problems, such as respiratory diseases, learning disabilities, and movement disorders , such as cerebral palsy. In addition, complications related to premature birth are the leading cause of death worldwide for children under 5 years of age.
However, preterm births could be reduced by improving the way pregnant women are screened, allowing early interventions if they are at high risk. For example, taking progesterone hormone supplements or suturing the cervix until near birth can delay preterm labor .
Currently, transvaginal ultrasound is widely used to predict the risk of preterm birth. It allows doctors to measure the length of the cervix – a cylindrical piece of tissue that connects the uterus and vagina – which acts as a protective barrier during pregnancy. It is normal for the cervix to shorten as the time of delivery approaches. But during the second trimester of pregnancy, the idea is that the shorter the cervix, the higher the risk of preterm labor.
Measuring the length of the cervix is not always a reliable indicator, as some women at risk do not realize it. “Of 10 women who will give birth prematurely, only four are correctly identified,” said Laura Bernardi, product manager for a company called Pregnolia , in Schlieren, Switzerland. “The remaining six are not identified and will not be treated to prolong the pregnancy. ”.
Rigidity
Cervical stiffness could be an alternative indicator of premature birth. Studies have shown that women with a softer cervix are at a higher risk of preterm labor . “Imagine the uterus as a balloon and the cervix as a knot,” said Bernardi. “If this knot is very soft, the baby is more likely to pass through the cervix, leading to birth.”
A study has shown that eight out of ten women at risk of giving birth prematurely could be identified using this method, suggesting that it could be a more effective detection method than the length of the cervix.
Pregnolia has developed a device, called the Pregnolia System , which is capable of measuring cervical stiffness . Created in the doctoral work of the CEO, Dr. Sabrina Badir, it consists of a probe that is inserted into the vagina until it touches the cervix. Then a small pump removes a sample of cervical tissue at the tip of the probe. In less than a minute, the device displays negative pressure, which is directly proportional to stiffness. “The higher the stiffness, the higher the required vacuum and vice versa,” said Bernardi.
The team is now working on reducing the cost of manufacturing as part of a project called Pregnolia. He is redesigning the disposable part of the device using plastic molding techniques such as extrusion and injection molding. “These techniques allow us to reduce production costs, simplifying the design, to minimize the amount of material used and to simplify the assembly,” said Bernardi.
His goal is also to develop a commercial device that can be used to diagnose premature birth . Currently, the system generates a measure of cervical stiffness that a physician can compare to a stiffness value at the same stage of pregnancy for women who have delivered at term using a table. However, it does not give a diagnosis.
The team members are conducting a human trial that should lead to the development of a diagnostic device. Their goal is to recruit 1,000 pregnant women for testing at UZ Leuven (a university hospital in Belgium) and 12 hospitals in Switzerland, where they will measure cervical stiffness using the Pregnolia device mid-pregnancy and investigate how their measurements relate to childbirth. early or timely.
“We expect the results of our study in about a year ,” Bernardi said. “Then we will be much more confident in giving an accurate diagnosis.”
Bernardi and his colleagues hope that their device will initially be used by doctors in hospitals and clinics. But it could also be used by nurses and midwives. As it is portable and only requires a gynecological chair for the examination, it could eventually be used outside of a clinical setting. “Theoretically, nothing prevents a midwife from going to a patient’s home and doing the measurement there,” Bernardi said. “The main advantage is that we have results in a few seconds or minutes and a doctor can directly initiate therapy.”
Nutrition
In cases where premature birth cannot be prevented, it is vital that babies receive proper nutrition to help prevent health problems. Babies born prematurely often do not get all the nutrients they need from breast milk alone, as it provides them with less protein, fat, and carbohydrates than they would get through the placenta if they were still in the womb.
” When we have a very premature baby, the nutrition from breast milk is not enough , so it has to be fortified,” said Isabel Correa, founder and CEO of a company called PREEMIE based in London, UK.
Currently, premature babies are often given standard fortified breast milk in neonatal units of hospitals. Doctors often test babies urine to determine if the supplement is adequate. But since it is not tailored to individual needs or to the specific human milk being used, there is a risk that the milk may be enriched too much or too little, which could lead to side effects such as kidney failure or a child’s predisposition to obesity.
Correa and his colleagues are developing a system to test the nutritional content of breast milk in a few seconds and calculate the necessary fortification based on the baby’s needs . It can measure how much protein, fat, lactose, and oligosaccharides – complex sugars – are in breast milk – as well as the freshness, or how long, of the milk in days.
“We are working so that the professionals of the neonatal ICU can perform a rapid and reliable analysis of a small amount of breast milk, thus providing better individualized fortification for premature babies”, said Professor Enrico Bertino, professor and director of the Unit Department of Neonatal Care at the University of Turin, in Italy, which is involved in a study of the Preemie device .
Milk banks
The objective is to develop an instrument that can be used in hospitals and human milk banks. In Europe, women can donate excess breast milk to these services. Milk is given to babies or premature babies whose mothers cannot breastfeed. But there is currently no cheap and easy way to taste the milk they receive. “We offer a quick way to analyze human milk received in a milk bank to check its deterioration and freshness, as well as its nutritional value,” said Correa.
So far, the team has a working prototype that uses Bluetooth to connect to an app on a smartphone or tablet. Two drops of breast milk are placed in a small container and inserted into the device where it is scanned by a sensor and analyzed using artificial intelligence. The nutritional content and freshness of the milk is displayed and then using information about the baby, such as its weight, fortification is recommended according to European guidelines. This can be adjusted by a doctor if necessary, Correa says.
Professor Bertino and his colleagues have started testing to validate the prototype for medical certification . They recently began collecting milk from a milk bank and from mothers of premature babies at the Sant’Anna Hospital in Turin with the aim of obtaining at least 350 samples. The tests will validate how the system and the sensor evaluate the content of different nutrients.
Correa and his colleagues are now working on commercializing the device as part of a project, also called Preemie. Once it is medically certified, which should be next year, the team hopes it will start to be used in neonatal units in hospitals across Europe. Eventually, they hope to make it available worldwide, where it could also be used outside of hospitals. “In the future we could be in a situation where mothers (with the advice of doctors) could enrich themselves at home,” Correa said.
Artículo original
This article was originally published in Horizon, the EU Research and Innovation Magazine
