Premature birth
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CORDIScovery podcast- Episode #35 - Premature birth
This is an AI transcription.
00:00:03:24 - 00:00:10:03
CORDIScovery
00:00:10:05 - 00:00:16:04
Abigail Acton
This is CORDIScovery.
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Abigail Acton
Hello and welcome to this episode of CORDIScovery, with me, Abigail Acton. About 500,000 babies are born early in Europe every year. One in ten births globally is premature. Being born before the 37th week can impact lungs, cause blindness, and interrupt the brain's development. For some, the condition is fatal. The World Health Organization recently reported there are approximately 6400 newborn deaths every day, amounting to nearly 47% of all child deaths under five.
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Abigail Acton
The EU has been funding research to find ways of mitigating the impact of premature birth and, where possible, averting it. Today, we'll be hearing from three researchers who have developed new approaches to helping preterm infants and their parents.
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Unknown
CORDIScovery.
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Abigail Acton
Audrey van der Meer is co-director of the Developmental Neuroscience Laboratory and professor of neuropsychology at the Norwegian University of Science and Technology in Trondheim. She is particularly interested in the infant brain with its enormous plasticity and capacity to learn from day one. Hello, Audrey.
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Audrey van der Meer
Hi there, Abigail.
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Abigail Acton
Isabel Hoffmann is a deep tech entrepreneur. By harnessing technology and connectivity, she is working to help create a world in which food contributes to health, not to societal diseases. Her company, Tellspec, is developing innovative ways of personalizing nutrition to help premature babies thrive. Hi, Isabelle.
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Isabel Hoffmann
Hi Abigail. Thank you.
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Abigail Acton
Julian Penders is co-founder of BloomLife, a company designing wearable technologies and predictive analytics to promote prenatal health. BloomLife's device is paired with data analytics to increase access to care, provide personalized feedback to mothers, and help doctors predict and manage pregnancy complications. Hi, Julian.
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Julien Penders
Hi Abigail. Pleased to be here.
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Abigail Acton
Pleasure to have you.
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Abigail Acton
Audrey, I'm going to turn to you first. The AIM_COACH project developed elegant experiments to analyze the brain signals of newborns and young children in order to better understand normal and abnormal brain development in full term and premature infants. What can happen to a child's brain if it is born prematurely? Audrey.
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Audrey van der Meer
Well, premature birth that will say before week 37 negatively affect the brain's full ding and myelinisation process. So there's a lot of folding happening in the brain during the third trimester of pregnancy, which is exactly the time when preterm babies are being born. And this process seems to be affected by the premature birth. So the folding is not as widespread as it is in babies that are allowed to go to term.
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Abigail Acton
And Audrey, what is myelinisation ?
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Audrey van der Meer
Myelinisation is about the formation of the fatty and myelin sheath around the brain cells. And poor myelinisation slows down the information processing in the brain and fewer brain folds. They give a reduced cortical area and volume.
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Abigail Acton
Right. And I believe there's something about the role of the dorsal stream. Can you explain what the dorsal stream is and how that's impacted?
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Audrey van der Meer
Yes, there are in the human brain, there are two visual processing streams called the dorsal stream and the ventral stream. The ventral stream goes from the back of the head to the temporal areas around the ears. And that is mostly involved in objects recognition and color perception. But the important thing about the ventral stream is that it's develops mainly after birth.
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Audrey van der Meer
So preterm birth doesn't affect the development of the ventral stream, whereas the dorsal stream that starts in the visual cortex at the back of the head and goes all the way up to the motor cortex at top of the head that the dorsal stream develops again. And mostly during the last trimester of pregnancy. And the dorsal stream is affected in a negative way by the preterm birth.
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Audrey van der Meer
Again, it seems as if the development of the dorsal stream is disrupted in some way or another. We don't know exactly what is happening, but it's caused by the baby being born too early.
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Abigail Acton
Okay. And what does this actually mean in terms of the child's development? I mean, how does it manifest itself after birth?
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Audrey van der Meer
Well, there are some typical dorsal stream function tests, and those include sensory motor integration, the planning of action, timing, prospective control, the ability to know what is going to happen in the near future, and the perception of distance, speed, direction and time to collision. So babies who are born prematurely, they often not all of them, but some babies, they develop a dorsal stream vulnerability, which means that they have difficulty when interacting with moving objects in the world around them.
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Abigail Acton
Okay. And so how did your project assess what was actually going on in the infants brains and what did you find? What did you set out to do and how did you do it? It must have been a challenge.
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Audrey van der Meer
Well, yes. Over the years, we have tested almost 500 babies in the first year of life, and we use our EEG, hair nets. Those are 128 electrodes sewn together in in the form of a hairnet that you place on the baby's head. And since the infant skull is much thinner than the adult skull, and also babies typically don't have much hair.
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Audrey van der Meer
So we record from the scalp electrical brain activity. So EEG is not sending anything into the baby's brain. It's just picking up electrical brain activity that is there. Always when you're alive, basically.
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Abigail Acton
And how successful were the computers that are picking up this brain activity? Did you manage to get information from every child upon which you put the upon whom you put the hairnet with the sensors, or was it very difficult to achieve?
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Audrey van der Meer
Well, what we do is we put the babies wearing the hairnets in a baby seat in front of a large screen, and we project balls looming balls that so balls that start small and that approach on a collision course and explode, so to speak, in the baby's face. And then the baby has to respond because these looming balls, they come under different speeds.
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Audrey van der Meer
So the baby has to predict when the ball is going to hit its face. And it does that by blinking or putting up its hands or ducking. But in addition, we also record a looming related brain response which occurs in the back of the brain in the visual cortex that can be analyzed. So then we used A.I. and machine learning to teach the computer to pick out these particular looming related brain responses.
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Audrey van der Meer
And we tested 50 young babies before they started crawling and 50 older babies after they had started crawling, different babies. And we taught the computer to pick out these brain waves automatically. And we had a 77% success rate, which is amazing given that this is baby brain data.
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Abigail Acton
Yeah, Fantastic. So you mean 77% of the time the computer was correctly able to interpret what was going on within the child's brain?
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Audrey van der Meer
Exactly. Yes.
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Abigail Acton
Fantastic. And these babies that you were looking at, were they all premature? I think you had some controls, you know, children that weren't born prematurely and children that were born.
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Audrey van der Meer
Yeah. Initially we used only full term babies. And we are going to apply the algorithms to pre-term babies.
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Abigail Acton
Excellent. So that you're hoping to see, then I guess, what the impact actually of the premature birth was on the way that the brain then functions with regards these stimulate sort of big bouncing balls coming towards them on a computer screen.
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Audrey van der Meer
Yeah, exactly. Yes.
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Abigail Acton
Okay. This is something I've just actually thought of all the balls, the same color. I mean, have you weeded out the possibility that bright red ball and bright green balls might elicit a different response from the babies?
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Audrey van der Meer
No, we have a ball consisted of different colors.
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Abigail Acton
like a beach ball?
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Audrey van der Meer
Yes, exactly. And it's rotating towards them.
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Abigail Acton
Okay. I see. Okay. Super. What's the point of this, Audrey? Tell me, how can your findings actually be used to help children that are showing a different rate of development?
00:08:59:13 - 00:09:43:22
Audrey van der Meer
Well, the idea is that if a particular baby's brain responses are flawed, that we then introduce online while the baby is sitting in the chair and watching these balls, we introduce a tailor made feedback loop, which means that we can, for instance, if a particular baby has difficulty with interpreting the fast speed looms approaching, then we can slow down the loom or we can add a sound which looms in a similar way as the visual ball looming towards the child to make the information more rich so that we can basically or ultimately facilitate perceptual learning in at-risk babies.
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Abigail Acton
So basically you're going to be enabling the child to recognize something which it can't recognize because of the impact of being born prematurely in other ways in order to what stimulate the part of the brain that needs to be developed because it's been impacted.
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Audrey van der Meer
Yeah, so that they can process the looms more precisely, and that will help them in their daily lives as well.
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Abigail Acton
Because it will build the brain up and increase the communication in the brain in that part.
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Audrey van der Meer
Yes, exactly. Visual motion perception is a very important way of using our brains because, you know, you need to be able to to tell speed distances when things are going to collide with you and when you are going to collide with other things, moving things. So it's very important. And that seems to be this dorsal stream.
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Audrey van der Meer
Vulnerability seems to happen a lot with babies who are born very preterm.
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Abigail Acton
Okay. And how are you hoping that this will be used? Are you hoping that medical professionals will be able to use this for children that are neurologically at risk?
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Audrey van der Meer
Yes, We hope that it allows medical professionals to provide babies at risk babies with an earlier diagnosis. And then, of course, if you are able to make an earlier diagnosis in the first year, let's say, then you also need to start working on intervention programs to help the baby to develop these dorsal stream functions better.
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Abigail Acton
That's fantastic. Very, very interesting research. Thank you so much, Audrey, for telling us about that. Does anyone have any questions or observations? Yes. Isabel, please.
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Isabel Hoffmann
Yes. I'm curious about how all this infants are.
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Audrey van der Meer
Well, we tested them in two groups, young babies, before they started crawling and older babies around 10 to 12 months after they started crawling around because we know that's the onset of self-produced locomotion gives a boost to both the perceptual systems and also to the brain.
00:11:45:24 - 00:12:06:15
Abigail Acton
I guess they're having to work out their place in the world themselves. And so it's already starting to exercise that part of the brain. Excellent. Okay. Well, thank you very much. Good question. Isabel, I'm going to turn to you. Actually, now it's your turn in the hot spot. The Preemie Project addressed a key problem in caring for premature infants, which is meeting their individual nutritional needs precisely and quickly to give them the very, very best start.
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Abigail Acton
Can you tell us a little bit about what the milk given to premature infants needs to contain, please?
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Isabel Hoffmann
So what we heard from Audrey is the fact that the babies these infants being premature, have missed the what's called the placental transfer, which is the last occurs during the last trimester of the pregnancy where the baby grabs from the mother, the placenta, tons of fat and protein to develop their lungs and their neurological system. So they miss that.
00:12:37:02 - 00:13:05:11
Isabel Hoffmann
They have deficiencies and disabilities as discussed. Unfortunately, breastmilk is designed for short term, not for preterm. So this poor little pre-term babies are born. And of course, breast milk is the best thing that we can give a preterm infant or any infant. In fact, breast milk is unique in the world because it contains oligosaccharides. There's over 200 oligosaccharides discovered.
00:13:05:13 - 00:13:29:17
Isabel Hoffmann
These are sugars that seed the infant, its gastrointestinal system with good bacteria. They act as seeds for good bacteria. So they are really boosting their immune system and very important. And they are unique because we have not been able to synthesize these oligosaccharides. So, in fact, we have only synthesized one out of the 200 so far.
00:13:29:23 - 00:13:56:16
Isabel Hoffmann
So we need to use human milk or breast milk to feed these little babies. But the breast milk is short in terms of fat and protein and specifically for brain development in terms of fatty acids, certain fatty acids. So the brain is not developing if it does not have the fatty acids, as we just heard a few seconds ago.
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Isabel Hoffmann
So we need to sort of say fortify the human milk, the breast milk.
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Abigail Acton
So how is breast milk fortified to add these vital components at the moment then Isabel?
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Isabel Hoffmann
So we have currents, some guidelines that we follow in the neonatal intensive care units. These guidelines and the recommendations given by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition. So these guidelines are great, but they are very difficult to follow because breast milk, human breast milk varies day to day and week to week. And even the diet from the mother.
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Isabel Hoffmann
So to add certain fortifiers so they exist to the milk, we need to measure the actual human milk. And this is where the difficulty comes in, is a first instrument that can measure the human milk and then adds and calculates the necessary fortifications. Now, in the very busy neonatal intensive care unit, typically nurses don't have the time to make those calculations, and those calculations should be done not just based on weight, but also based on risk factors that the baby may have as, for instance, some of these preterm babies.
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Isabel Hoffmann
They may have bronchotone displeasure, which is very common and essentially similar to asthma, and they need more energy to actually do the breathing. So there are extra guidelines for specific situations.
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Abigail Acton
So it sounds as if the current system is both quite complicated and yet at the same time not particularly sophisticated in that it's not targeting individual needs, individual breast milk composition, individual infant needs. Is that correct?
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Isabel Hoffmann
That's correct.
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Abigail Acton
So what is preemie doing that's different then?
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Isabel Hoffmann
Yeah, exactly. The preemie system is really designed to be a personalized feeding system for preterm infants. So we've measured the human milk in a few seconds and we calculate using machine learning and the guidelines, the necessary fortification, and we deliver immediate results such as for this amount of milk, you add this a lot of fortifier and so it makes it very transparent for the nurse to do fantastic.
00:16:18:09 - 00:16:25:22
Abigail Acton
So they take a sample, they drop it into water, kind of like a is it like a little slide that they put into a machine or how does that actually work? How does it manifest itself?
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Isabel Hoffmann
No they actually have to measure the fortifier and then add it to the milk.
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Abigail Acton
sure, sure. But how do they detect what's in the in the breast milk?
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Isabel Hoffmann
yes. So the Preemie system has what it's called the preemie sensor, which is actually a spectrometer. So they dropped literally two drops of milk. 0.35 milliliters. So almost no human milk at all inserted into the sensor. Press the button and 2 seconds. 2 to 5 seconds later, they have the results of the composition of the milk in terms of protein, fat and fatty acids, energy and carbs.
00:17:05:23 - 00:17:08:24
Abigail Acton
And the guidelines necessary for them to know what fortification to use.
00:17:09:01 - 00:17:15:20
Isabel Hoffmann
Once they decide to use that milk. Yeah, because they may not they can ask for the calculations. That's correct.
00:17:15:24 - 00:17:25:10
Abigail Acton
Okay. That's fantastic. That sounds absolutely brilliant. Fantastic. And where are you with this machine? Is it is it something that you're noticing is being used? Is the uptake there?
00:17:25:12 - 00:17:48:09
Isabel Hoffmann
Yes. The machine is actually a simple medical device, but the software is not as simple. This software that does the calculations goes back in line. So actually, you can give the neonatologist an idea of what fortification was done and what total feeding the baby received at a certain date. And map that in terms of the growth of the baby in growth charts.
00:17:48:10 - 00:18:13:09
Isabel Hoffmann
So really we have a tool that allows and, you know, neonatologists to actually understand if there is a growth faltering, if the baby's striving, if it needs to be changed. So we currently we have done initial clinical trials in Turin, in Italy in and now we are doing a full fledged clinical trial in Southampton and we are just starting May 1st.
00:18:13:09 - 00:18:27:17
Isabel Hoffmann
It's probably going to take another year at least if not 18 months, and involves new certification guidelines that we have to respect. Now since 2022 and involves not just a medical device certification, but also the software certification.
00:18:27:18 - 00:18:41:10
Abigail Acton
Right. So basically, you're just in the process of going through the certification. And I mean, I guess you're hoping that this will clear and that maybe it will be usable. Any idea when it might be something that we could see?
00:18:41:10 - 00:18:44:07
Isabel Hoffmann
We aiming at mid 2025?
00:18:44:12 - 00:18:59:06
Abigail Acton
Fantastic. Not so far away at all. Very good. That's very exciting. It's a lot of work. I know that you travel a lot and it's very demanding and you know, you have the company that you yourself have created. And then plus also this project. What motivated you to get involved in all of this?
00:18:59:08 - 00:19:25:14
Isabel Hoffmann
Well, the company itself started by looking at nutrition and looking at what we eat every day. And how untransparent food system is and all we need as consumers to have some transparency and demand some accountability from the food system. So it's that's how it started. But the goal was to have a small device to scan the food for the consumer.
00:19:25:16 - 00:19:47:21
Isabel Hoffmann
This is a Google world, right? I mean, it will be requiring a Google massive amount of investment, which we didn't get. So we had to focus. And we had an employee that had a sister that had a premature baby and she was devastated. She was coming in everyday to work crying.
00:19:47:23 - 00:20:09:01
Isabel Hoffmann
So I start looking at it and I understood that, you know, the hospital was not even doing any fortification because sometimes hospitals do standard fortification. Not even the standard fortification was being done. And so I thought, my God, you know, the problem is that they don't know where to start. Even they cannot measure the human milk.
00:20:09:06 - 00:20:19:19
Isabel Hoffmann
So how can they even start by following some guidelines? And I thought, okay, this is a perfect application for a good sensor. And so we develop our second sensor for creamy applications.
00:20:19:20 - 00:20:28:03
Abigail Acton
Fantastic. Excellent, excellent work as well. Thank you. That's wonderful. Does anyone have any observations or comments to make to Isabelle? Julien Yes, please.
00:20:28:05 - 00:20:48:19
Julien Penders
Great work Isabel. Have a question for you is I would assume that the medical position evolves over time and if that's the case, any thoughts of applying the same technology to kind of continue to help the mom when she goes back home, you know, after the premature kneecap to continue to adapt to fortification based on the changing needs?
00:20:48:21 - 00:21:08:07
Isabel Hoffmann
Yeah, I would hope that that's the case as well, that, you know, eventually the device, because it's very easy to use, becomes in stays in the hands of the mother, even if the mother just brings it from the hospital. But we have to do baby steps to get there because I think, you know, first of all, device has to be certified.
00:21:08:07 - 00:21:32:11
Isabel Hoffmann
Second has to be proven that, in fact, it helps, you know, based on the literature, we can reduce, you know, 4% of occurrence of necrotizing enterocolitis and 4% of bronchopulmonary displeasure, as well as 10% of sepsis. And those are three diseases that these babies really have. But we need much more data in order to have that acknowledge certified by the doctors, accepted by the doctors.
00:21:32:16 - 00:21:50:22
Isabel Hoffmann
And then maybe in a few years from now, I see in all the hospitals having those sensors and the mother either comes in or the mother takes as a rental similar to the breast pumps. You know, I remember when I had my first child, you know, breast pumps not commercially available. And we would go to the hospital to do that.
00:21:50:22 - 00:21:55:06
Isabel Hoffmann
I mean, that's what I envision I envision this to happen in a few years from now.
00:21:55:11 - 00:21:57:01
Abigail Acton
Fantastic. Great, isn't it?
00:21:57:03 - 00:21:57:11
Julien Penders
Thank you.
00:21:57:12 - 00:22:17:17
Abigail Acton
It's fantastic. And it's wonderful. It's lovely to see all these sort of cutting edge technologies being put to such practical applications. Talking of which, Julian, cutting edge technologies, I think we're coming over to you now. The WISH Project enabled BloomLife, the company behind it, to complete the development of a wearable that can help to predict and detect the onset of preterm labor, which sounds just fantastic.
00:22:17:17 - 00:22:33:15
Abigail Acton
So we've been looking a little bit at the impact of preterm birth, and we've been looking at how we can mitigate that with the right nutrition. But how about trying to avoid it altogether? Why premature birth? Julian There are a lot of areas in which telemedicine and wearables are expanding, but you chose to look at the solution. Why?
00:22:33:16 - 00:22:59:10
Julien Penders
Yeah, great question. I think looking at the prenatal period started from my own personal experience. It was actually my wife's first pregnancy was for me an eyeopener on the technology and data gaps that exist today in maternal and prenatal care. So my first case, we were lucky that she ended up having a safe and healthy pregnancy, but I wasn't without much anxiety and uncertainty about how the baby is doing and to do's and don'ts around pregnancy movement, use VR.
00:22:59:11 - 00:23:21:13
Julien Penders
And something said, you know, something could be wrong. And then shortly after our pregnancy, my sister got pregnant and she ended up delivering twins preterm at 33 weeks. And then my two nephews had to spend several weeks in the NICU. It was very emotionally hard for my sister and for me as well. From a distance. And that's really where I started to get interested into preterm birth.
00:23:21:15 - 00:23:40:24
Julien Penders
It was something that technology could do to help detect that earlier or to risk. They take the risk earlier and be able to intervene. If you look at it from a global perspective, you know, my and my sister's case wasn't unique. There are 50 million babies born preterm every year in the world, 1 million of them will not make it to the age of five due to consequences of preterm birth.
00:23:41:01 - 00:24:00:01
Julien Penders
Preterm birth is the number one killer of children under five years old. And that's why I think the innovation that we heard before are great, you know, helping to diminish these numbers. But it's still very important to be able to deal with the consequences afterwards. Okay. From our perspective, replicated in terms of technology, we think that better technology would lead to better data.
00:24:00:01 - 00:24:06:15
Julien Penders
That better data will, in turn, to help us reduce the impact of burden of preterm birth. And that's really where the WISH Project comes in.
00:24:06:17 - 00:24:12:17
Abigail Acton
Okay. So tell me a little bit about the current ways of monitoring mother and baby health and how can they be improved on?
00:24:12:19 - 00:24:33:18
Julien Penders
Yeah, well, I've got to say that maternal health and wellness has in general has long been the land that science forgot. If you look at what doctors use today to evolve technology, it was first introduced in the seventies. It's called the Cogito Program. It's a machine with balance and a big machine next to mom. And again, it's been there for close to 55 years now.
00:24:33:20 - 00:24:49:02
Julien Penders
That means that doctors make very important decisions. So the case of a pregnant mum and her baby, based on very limited data collected during spot checks, visit at the clinics, and that is very much the technology and data gap has that we try to address with the WISH project?
00:24:49:05 - 00:24:52:14
Abigail Acton
Right. Okay. So what did you guys actually develop them?
00:24:52:16 - 00:25:18:11
Julien Penders
So the project was really about developing a wearable sensor that could be used longitudinally during the prenatal period. So it's a patch that is placed on the lower abdomen of a pregnant mum. It measures a bunch of physiological parameters for mum and baby and yeah, it is to use a physiological digital biomarker that we developed during the project to detect the onset of labor or pre-term labor.
00:25:18:11 - 00:25:45:24
Julien Penders
And so the idea is that it was dispatched, a woman can wear it a couple of hours per day. Well, analyze the data based on this biomarker and then we will identify the risk of getting into labor. And that risk then can be shared with the moment, especially her doctor and if the risk goes to high. Then the doctor can be informed about that and you can take into prevention is to actually either, you know, get a mom in if she's already in contractions so that she is okay.
00:25:45:24 - 00:26:06:11
Abigail Acton
So basically that means that the monitoring is done in the comfort of the woman's own home. There is much less stress with regards to not having to go to and from hospital or medical health checkups, etc., etc.. And it's real time. So this sensor collects data and what it's automatically transmitted to the cloud where it can be shared with people who have password access or something like that.
00:26:06:11 - 00:26:07:13
Abigail Acton
How does that work?
00:26:07:15 - 00:26:32:22
Julien Penders
Yeah, that's right. So imagine a device connected by the sensor. It's pre processed on the sensor and then it's sent indeed, in the cloud. In the cloud we have the AI that runs that will extract this physiological marker from the physiological data. And then it will compute a likelihood of a mum going into labor, that information is then shared with the doctor and the mum and dad basically hubs drive possible clinical action.
00:26:33:00 - 00:26:41:19
Abigail Acton
Right. And I believe actually it can perhaps also measure fetal heart rate, which is obviously I think something that will give a woman a lot of reassurance. And also the doctor concerned, are you finding that?
00:26:41:22 - 00:27:01:07
Julien Penders
Yeah, that's some of the work that we've done after the WISH Project, which is really focused on can we identify, you know, early signs of labor onset because of those applications to predict birth after that, we continue the development and once she has the sensor on the lower abdomen, there are many other parameters that we can measure. And one of them is indeed the fetal heartbeat.
00:27:01:07 - 00:27:14:05
Julien Penders
It's kind of the it's the other side of the equation, right? So you want to know when the mum is going to get into labor. You also want to know if the baby's okay. And in fact, our hardware tells you that information. And so the idea is that the technology that we have developed allow us to do both.
00:27:14:07 - 00:27:20:15
Julien Penders
There are ways to have an idea of when the mum is going to get into labor, but also to see if the baby's okay.
00:27:20:17 - 00:27:32:18
Abigail Acton
Okay, That sounds fantastic. And where are you up to with this? I mean this you have prototypes for you in clinical trials. What's the situation? There might be people listening to this right now thinking, Gosh, I want to lay my hands on one of those. But what can you tell them?
00:27:32:21 - 00:27:56:00
Julien Penders
Well, we know we're working as hard and as quickly as we can to get this to market. The WISH project was very important for us because it was really covering the development of that digital biomarker, but also it's validation and prospective clinical trial. So that trial allows us to show that we were able to detect the labor with an equivalent accuracy.
00:27:56:02 - 00:28:17:07
Julien Penders
To a diagnostic of labor, although the mum is home, she doesn't need to go to the hospital. So that was very important for us. Now the next step is really for us to continue the validation of the device and the biomarker get regulatory approval in Europe, CE marking and then eventually be able to to have this technology in the hands of mums and the care team.
00:28:17:08 - 00:28:27:01
Abigail Acton
Fantastic. That sounds wonderful. Really, really good. And I think you already have FDA, that's the American Association's clearance and you're going for a CE mark at the moment and for Europe. Yes?
00:28:27:03 - 00:28:41:17
Julien Penders
Yeah, that's correct. The first FDA clearance was actually for fetal heartrate, this was the first clearance we got. So we still need to work on our clearance for detection, that's in the pipeline. And we are indeed pursuing to get a CE mark.
00:28:41:21 - 00:28:49:15
Abigail Acton
Fantastic. Excellent, Excellent. Thank you. This sounds really innovative. Julian. Super.
00:28:49:17 - 00:29:16:08
Isabel Hoffmann
Yes. When I was listening to you, I was thinking about the fact that some small for gestational age babies, they often show signs that they would have been better off outside of the womb, for instance, because of maternal placental deficiency or things like that. So could you actually use your device to get out babies that are not thriving?
00:29:16:10 - 00:29:37:17
Julien Penders
And it's a it's a great question. We think. Yes. But of course, we still need to do the work to prove that the fundamentally with a device that as it's measure the heart rate of the baby, the heart rate of the mom and uterus contractility. And these are the three parameters that help you get a full diagnostic of what's happening during pregnancy about mom and baby.
00:29:37:22 - 00:30:04:23
Julien Penders
And so with the example of support for gestational age, a fetus is at the stage where indeed some placental disorders or complications will start impacting the baby. You will see that by a decreased level of fetal movement. You can see that by a decrease of activity of the fetus heart rate. These are things that we can indeed measure with the device and using that, absolutely start giving early signs or early indications that something may be wrong.
00:30:05:04 - 00:30:23:13
Julien Penders
So that is absolutely where we want to take this. This is our vision longterm like 5 to 7 years, could we detect early signs of stillbirth? That's really pushing this to the extreme and so the science has to be down there. There is a huge technology gap and data gap in this space.
00:30:23:18 - 00:30:41:18
Julien Penders
And, you know, our first step is to bring the technology that allows us to collect the data. And once we have that data, we can start asking those questions and see, okay, can we see physiological signs for different type of complications and then try to anticipate that? So it's absolutely part of the roadmap. It's you know, it's just so much to do, but we have to start somewhere.
00:30:41:18 - 00:30:45:09
Julien Penders
But yeah, it's a it's a great question. And is something we'd like to do in the future.
00:30:45:12 - 00:31:03:07
Abigail Acton
Exciting times. Julian, exciting times. So basically anything you're doing is going to be moving the whole situation forward rather than taking women regularly into health checks and putting them on to great big monitors where they're. Yeah, spot checks, as you say, is passé now, isn't it? Great.
00:31:04:02 - 00:31:06:13
Abigail Acton
Okay. Well, guys, thank you very, very much for your time. I think the work is just is just wonderful and on all sorts of different levels and how it all comes together, clearly it's an open door into better horizons.
00:31:06:13 - 00:31:15:07
Abigail Acton
This is just really good stuff. Thank you for your time.
00:31:16:12 - 00:31:17:54
Isabel Hoffmann
Thank you.
00:31:18:10 - 00:31:18:50
Audrey van der Meer
Thank you too.
00:31:19:12 - 00:31:20:17
Julien Penders
Thanks again. It was great to be part of this.
00:31:23:08 - 00:31:45:19
Abigail Acton
You're very welcome. If you like this podcast, follow us to make sure that the hottest research and EU funded science isn't passing you by. And if you've enjoyed listening, then why not spread the word? We've talked about insights into how to deal with another pandemic, how augmented reality could save lives in the event of a fire on board ship, and the role of soil bacteria in helping plants thrive.
00:31:46:23 - 00:32:04:01
Abigail Acton
In our last 34 episodes, there'll be something there to tweak your curiosity. Perhaps you want to know what other EU funded projects are doing to mitigate the impact of premature birth and establish new methods of prevention. The CORDIS website will give you an insight into the results of projects funded by the Horizon 2020 Program and Horizon Europe that are working in this area.
00:32:05:03 - 00:32:25:21
Abigail Acton
The website has articles and interviews that explore the results of research being conducted in a very broad range of domains in subjects from Plutarch to plutonium. There is something there for you. Maybe you're involved in a project or would like to apply for funding. Take a look at what others are doing in your domain. So come and check out the research that's revealing what makes our world tick.
00:32:26:23 - 00:32:33:23
Abigail Acton
We're always happy to hear from you. Drop us a line editorial at CORDIS dot Europa dot EU. Until next time.
This is an AI transcription.
00:00:03:24 - 00:00:10:03
CORDIScovery
00:00:10:05 - 00:00:16:04
Abigail Acton
This is CORDIScovery.
00:00:16:06 - 00:00:46:06
Abigail Acton
Hello and welcome to this episode of CORDIScovery, with me, Abigail Acton. About 500,000 babies are born early in Europe every year. One in ten births globally is premature. Being born before the 37th week can impact lungs, cause blindness, and interrupt the brain's development. For some, the condition is fatal. The World Health Organization recently reported there are approximately 6400 newborn deaths every day, amounting to nearly 47% of all child deaths under five.
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Abigail Acton
The EU has been funding research to find ways of mitigating the impact of premature birth and, where possible, averting it. Today, we'll be hearing from three researchers who have developed new approaches to helping preterm infants and their parents.
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Unknown
CORDIScovery.
00:01:01:14 - 00:01:18:11
Abigail Acton
Audrey van der Meer is co-director of the Developmental Neuroscience Laboratory and professor of neuropsychology at the Norwegian University of Science and Technology in Trondheim. She is particularly interested in the infant brain with its enormous plasticity and capacity to learn from day one. Hello, Audrey.
00:01:18:13 - 00:01:20:11
Audrey van der Meer
Hi there, Abigail.
00:01:20:13 - 00:01:39:10
Abigail Acton
Isabel Hoffmann is a deep tech entrepreneur. By harnessing technology and connectivity, she is working to help create a world in which food contributes to health, not to societal diseases. Her company, Tellspec, is developing innovative ways of personalizing nutrition to help premature babies thrive. Hi, Isabelle.
00:01:39:12 - 00:01:41:11
Isabel Hoffmann
Hi Abigail. Thank you.
00:01:41:13 - 00:02:00:17
Abigail Acton
Julian Penders is co-founder of BloomLife, a company designing wearable technologies and predictive analytics to promote prenatal health. BloomLife's device is paired with data analytics to increase access to care, provide personalized feedback to mothers, and help doctors predict and manage pregnancy complications. Hi, Julian.
00:02:00:19 - 00:02:02:22
Julien Penders
Hi Abigail. Pleased to be here.
00:02:02:24 - 00:02:03:13
Abigail Acton
Pleasure to have you.
00:02:04:06 - 00:02:21:24
Abigail Acton
Audrey, I'm going to turn to you first. The AIM_COACH project developed elegant experiments to analyze the brain signals of newborns and young children in order to better understand normal and abnormal brain development in full term and premature infants. What can happen to a child's brain if it is born prematurely? Audrey.
00:02:22:01 - 00:02:59:02
Audrey van der Meer
Well, premature birth that will say before week 37 negatively affect the brain's full ding and myelinisation process. So there's a lot of folding happening in the brain during the third trimester of pregnancy, which is exactly the time when preterm babies are being born. And this process seems to be affected by the premature birth. So the folding is not as widespread as it is in babies that are allowed to go to term.
00:02:59:04 - 00:03:00:20
Abigail Acton
And Audrey, what is myelinisation ?
00:03:01:00 - 00:03:20:13
Audrey van der Meer
Myelinisation is about the formation of the fatty and myelin sheath around the brain cells. And poor myelinisation slows down the information processing in the brain and fewer brain folds. They give a reduced cortical area and volume.
00:03:20:15 - 00:03:28:06
Abigail Acton
Right. And I believe there's something about the role of the dorsal stream. Can you explain what the dorsal stream is and how that's impacted?
00:03:28:08 - 00:03:57:09
Audrey van der Meer
Yes, there are in the human brain, there are two visual processing streams called the dorsal stream and the ventral stream. The ventral stream goes from the back of the head to the temporal areas around the ears. And that is mostly involved in objects recognition and color perception. But the important thing about the ventral stream is that it's develops mainly after birth.
00:03:57:14 - 00:04:26:24
Audrey van der Meer
So preterm birth doesn't affect the development of the ventral stream, whereas the dorsal stream that starts in the visual cortex at the back of the head and goes all the way up to the motor cortex at top of the head that the dorsal stream develops again. And mostly during the last trimester of pregnancy. And the dorsal stream is affected in a negative way by the preterm birth.
00:04:27:04 - 00:04:38:06
Audrey van der Meer
Again, it seems as if the development of the dorsal stream is disrupted in some way or another. We don't know exactly what is happening, but it's caused by the baby being born too early.
00:04:38:10 - 00:04:44:07
Abigail Acton
Okay. And what does this actually mean in terms of the child's development? I mean, how does it manifest itself after birth?
00:04:44:09 - 00:05:21:09
Audrey van der Meer
Well, there are some typical dorsal stream function tests, and those include sensory motor integration, the planning of action, timing, prospective control, the ability to know what is going to happen in the near future, and the perception of distance, speed, direction and time to collision. So babies who are born prematurely, they often not all of them, but some babies, they develop a dorsal stream vulnerability, which means that they have difficulty when interacting with moving objects in the world around them.
00:05:21:12 - 00:05:30:14
Abigail Acton
Okay. And so how did your project assess what was actually going on in the infants brains and what did you find? What did you set out to do and how did you do it? It must have been a challenge.
00:05:30:16 - 00:06:00:19
Audrey van der Meer
Well, yes. Over the years, we have tested almost 500 babies in the first year of life, and we use our EEG, hair nets. Those are 128 electrodes sewn together in in the form of a hairnet that you place on the baby's head. And since the infant skull is much thinner than the adult skull, and also babies typically don't have much hair.
00:06:00:24 - 00:06:17:13
Audrey van der Meer
So we record from the scalp electrical brain activity. So EEG is not sending anything into the baby's brain. It's just picking up electrical brain activity that is there. Always when you're alive, basically.
00:06:17:15 - 00:06:29:16
Abigail Acton
And how successful were the computers that are picking up this brain activity? Did you manage to get information from every child upon which you put the upon whom you put the hairnet with the sensors, or was it very difficult to achieve?
00:06:29:18 - 00:06:58:08
Audrey van der Meer
Well, what we do is we put the babies wearing the hairnets in a baby seat in front of a large screen, and we project balls looming balls that so balls that start small and that approach on a collision course and explode, so to speak, in the baby's face. And then the baby has to respond because these looming balls, they come under different speeds.
00:06:58:13 - 00:07:29:13
Audrey van der Meer
So the baby has to predict when the ball is going to hit its face. And it does that by blinking or putting up its hands or ducking. But in addition, we also record a looming related brain response which occurs in the back of the brain in the visual cortex that can be analyzed. So then we used A.I. and machine learning to teach the computer to pick out these particular looming related brain responses.
00:07:29:13 - 00:07:52:16
Audrey van der Meer
And we tested 50 young babies before they started crawling and 50 older babies after they had started crawling, different babies. And we taught the computer to pick out these brain waves automatically. And we had a 77% success rate, which is amazing given that this is baby brain data.
00:07:52:17 - 00:07:59:19
Abigail Acton
Yeah, Fantastic. So you mean 77% of the time the computer was correctly able to interpret what was going on within the child's brain?
00:07:59:23 - 00:08:01:07
Audrey van der Meer
Exactly. Yes.
00:08:01:07 - 00:08:09:24
Abigail Acton
Fantastic. And these babies that you were looking at, were they all premature? I think you had some controls, you know, children that weren't born prematurely and children that were born.
00:08:10:04 - 00:08:19:03
Audrey van der Meer
Yeah. Initially we used only full term babies. And we are going to apply the algorithms to pre-term babies.
00:08:19:05 - 00:08:29:18
Abigail Acton
Excellent. So that you're hoping to see, then I guess, what the impact actually of the premature birth was on the way that the brain then functions with regards these stimulate sort of big bouncing balls coming towards them on a computer screen.
00:08:29:19 - 00:08:31:08
Audrey van der Meer
Yeah, exactly. Yes.
00:08:31:14 - 00:08:41:09
Abigail Acton
Okay. This is something I've just actually thought of all the balls, the same color. I mean, have you weeded out the possibility that bright red ball and bright green balls might elicit a different response from the babies?
00:08:41:11 - 00:08:46:00
Audrey van der Meer
No, we have a ball consisted of different colors.
00:08:46:04 - 00:08:46:24
Abigail Acton
like a beach ball?
00:08:47:00 - 00:08:50:10
Audrey van der Meer
Yes, exactly. And it's rotating towards them.
00:08:50:12 - 00:08:59:09
Abigail Acton
Okay. I see. Okay. Super. What's the point of this, Audrey? Tell me, how can your findings actually be used to help children that are showing a different rate of development?
00:08:59:13 - 00:09:43:22
Audrey van der Meer
Well, the idea is that if a particular baby's brain responses are flawed, that we then introduce online while the baby is sitting in the chair and watching these balls, we introduce a tailor made feedback loop, which means that we can, for instance, if a particular baby has difficulty with interpreting the fast speed looms approaching, then we can slow down the loom or we can add a sound which looms in a similar way as the visual ball looming towards the child to make the information more rich so that we can basically or ultimately facilitate perceptual learning in at-risk babies.
00:09:43:24 - 00:09:57:13
Abigail Acton
So basically you're going to be enabling the child to recognize something which it can't recognize because of the impact of being born prematurely in other ways in order to what stimulate the part of the brain that needs to be developed because it's been impacted.
00:09:57:15 - 00:10:04:22
Audrey van der Meer
Yeah, so that they can process the looms more precisely, and that will help them in their daily lives as well.
00:10:05:01 - 00:10:08:07
Abigail Acton
Because it will build the brain up and increase the communication in the brain in that part.
00:10:08:07 - 00:10:33:17
Audrey van der Meer
Yes, exactly. Visual motion perception is a very important way of using our brains because, you know, you need to be able to to tell speed distances when things are going to collide with you and when you are going to collide with other things, moving things. So it's very important. And that seems to be this dorsal stream.
00:10:33:19 - 00:10:38:17
Audrey van der Meer
Vulnerability seems to happen a lot with babies who are born very preterm.
00:10:38:20 - 00:10:45:15
Abigail Acton
Okay. And how are you hoping that this will be used? Are you hoping that medical professionals will be able to use this for children that are neurologically at risk?
00:10:45:18 - 00:11:07:21
Audrey van der Meer
Yes, We hope that it allows medical professionals to provide babies at risk babies with an earlier diagnosis. And then, of course, if you are able to make an earlier diagnosis in the first year, let's say, then you also need to start working on intervention programs to help the baby to develop these dorsal stream functions better.
00:11:07:23 - 00:11:15:18
Abigail Acton
That's fantastic. Very, very interesting research. Thank you so much, Audrey, for telling us about that. Does anyone have any questions or observations? Yes. Isabel, please.
00:11:15:20 - 00:11:19:22
Isabel Hoffmann
Yes. I'm curious about how all this infants are.
00:11:19:24 - 00:11:45:06
Audrey van der Meer
Well, we tested them in two groups, young babies, before they started crawling and older babies around 10 to 12 months after they started crawling around because we know that's the onset of self-produced locomotion gives a boost to both the perceptual systems and also to the brain.
00:11:45:24 - 00:12:06:15
Abigail Acton
I guess they're having to work out their place in the world themselves. And so it's already starting to exercise that part of the brain. Excellent. Okay. Well, thank you very much. Good question. Isabel, I'm going to turn to you. Actually, now it's your turn in the hot spot. The Preemie Project addressed a key problem in caring for premature infants, which is meeting their individual nutritional needs precisely and quickly to give them the very, very best start.
00:12:06:17 - 00:12:12:11
Abigail Acton
Can you tell us a little bit about what the milk given to premature infants needs to contain, please?
00:12:12:13 - 00:12:37:00
Isabel Hoffmann
So what we heard from Audrey is the fact that the babies these infants being premature, have missed the what's called the placental transfer, which is the last occurs during the last trimester of the pregnancy where the baby grabs from the mother, the placenta, tons of fat and protein to develop their lungs and their neurological system. So they miss that.
00:12:37:02 - 00:13:05:11
Isabel Hoffmann
They have deficiencies and disabilities as discussed. Unfortunately, breastmilk is designed for short term, not for preterm. So this poor little pre-term babies are born. And of course, breast milk is the best thing that we can give a preterm infant or any infant. In fact, breast milk is unique in the world because it contains oligosaccharides. There's over 200 oligosaccharides discovered.
00:13:05:13 - 00:13:29:17
Isabel Hoffmann
These are sugars that seed the infant, its gastrointestinal system with good bacteria. They act as seeds for good bacteria. So they are really boosting their immune system and very important. And they are unique because we have not been able to synthesize these oligosaccharides. So, in fact, we have only synthesized one out of the 200 so far.
00:13:29:23 - 00:13:56:16
Isabel Hoffmann
So we need to use human milk or breast milk to feed these little babies. But the breast milk is short in terms of fat and protein and specifically for brain development in terms of fatty acids, certain fatty acids. So the brain is not developing if it does not have the fatty acids, as we just heard a few seconds ago.
00:13:56:18 - 00:14:00:05
Isabel Hoffmann
So we need to sort of say fortify the human milk, the breast milk.
00:14:00:07 - 00:14:04:17
Abigail Acton
So how is breast milk fortified to add these vital components at the moment then Isabel?
00:14:04:17 - 00:14:35:01
Isabel Hoffmann
So we have currents, some guidelines that we follow in the neonatal intensive care units. These guidelines and the recommendations given by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition. So these guidelines are great, but they are very difficult to follow because breast milk, human breast milk varies day to day and week to week. And even the diet from the mother.
00:14:35:01 - 00:15:13:22
Isabel Hoffmann
So to add certain fortifiers so they exist to the milk, we need to measure the actual human milk. And this is where the difficulty comes in, is a first instrument that can measure the human milk and then adds and calculates the necessary fortifications. Now, in the very busy neonatal intensive care unit, typically nurses don't have the time to make those calculations, and those calculations should be done not just based on weight, but also based on risk factors that the baby may have as, for instance, some of these preterm babies.
00:15:13:22 - 00:15:32:08
Isabel Hoffmann
They may have bronchotone displeasure, which is very common and essentially similar to asthma, and they need more energy to actually do the breathing. So there are extra guidelines for specific situations.
00:15:32:10 - 00:15:47:00
Abigail Acton
So it sounds as if the current system is both quite complicated and yet at the same time not particularly sophisticated in that it's not targeting individual needs, individual breast milk composition, individual infant needs. Is that correct?
00:15:47:06 - 00:15:47:23
Isabel Hoffmann
That's correct.
00:15:48:04 - 00:15:50:19
Abigail Acton
So what is preemie doing that's different then?
00:15:51:00 - 00:16:18:09
Isabel Hoffmann
Yeah, exactly. The preemie system is really designed to be a personalized feeding system for preterm infants. So we've measured the human milk in a few seconds and we calculate using machine learning and the guidelines, the necessary fortification, and we deliver immediate results such as for this amount of milk, you add this a lot of fortifier and so it makes it very transparent for the nurse to do fantastic.
00:16:18:09 - 00:16:25:22
Abigail Acton
So they take a sample, they drop it into water, kind of like a is it like a little slide that they put into a machine or how does that actually work? How does it manifest itself?
00:16:26:02 - 00:16:33:03
Isabel Hoffmann
No they actually have to measure the fortifier and then add it to the milk.
00:16:33:08 - 00:16:36:11
Abigail Acton
sure, sure. But how do they detect what's in the in the breast milk?
00:16:37:00 - 00:17:05:23
Isabel Hoffmann
yes. So the Preemie system has what it's called the preemie sensor, which is actually a spectrometer. So they dropped literally two drops of milk. 0.35 milliliters. So almost no human milk at all inserted into the sensor. Press the button and 2 seconds. 2 to 5 seconds later, they have the results of the composition of the milk in terms of protein, fat and fatty acids, energy and carbs.
00:17:05:23 - 00:17:08:24
Abigail Acton
And the guidelines necessary for them to know what fortification to use.
00:17:09:01 - 00:17:15:20
Isabel Hoffmann
Once they decide to use that milk. Yeah, because they may not they can ask for the calculations. That's correct.
00:17:15:24 - 00:17:25:10
Abigail Acton
Okay. That's fantastic. That sounds absolutely brilliant. Fantastic. And where are you with this machine? Is it is it something that you're noticing is being used? Is the uptake there?
00:17:25:12 - 00:17:48:09
Isabel Hoffmann
Yes. The machine is actually a simple medical device, but the software is not as simple. This software that does the calculations goes back in line. So actually, you can give the neonatologist an idea of what fortification was done and what total feeding the baby received at a certain date. And map that in terms of the growth of the baby in growth charts.
00:17:48:10 - 00:18:13:09
Isabel Hoffmann
So really we have a tool that allows and, you know, neonatologists to actually understand if there is a growth faltering, if the baby's striving, if it needs to be changed. So we currently we have done initial clinical trials in Turin, in Italy in and now we are doing a full fledged clinical trial in Southampton and we are just starting May 1st.
00:18:13:09 - 00:18:27:17
Isabel Hoffmann
It's probably going to take another year at least if not 18 months, and involves new certification guidelines that we have to respect. Now since 2022 and involves not just a medical device certification, but also the software certification.
00:18:27:18 - 00:18:41:10
Abigail Acton
Right. So basically, you're just in the process of going through the certification. And I mean, I guess you're hoping that this will clear and that maybe it will be usable. Any idea when it might be something that we could see?
00:18:41:10 - 00:18:44:07
Isabel Hoffmann
We aiming at mid 2025?
00:18:44:12 - 00:18:59:06
Abigail Acton
Fantastic. Not so far away at all. Very good. That's very exciting. It's a lot of work. I know that you travel a lot and it's very demanding and you know, you have the company that you yourself have created. And then plus also this project. What motivated you to get involved in all of this?
00:18:59:08 - 00:19:25:14
Isabel Hoffmann
Well, the company itself started by looking at nutrition and looking at what we eat every day. And how untransparent food system is and all we need as consumers to have some transparency and demand some accountability from the food system. So it's that's how it started. But the goal was to have a small device to scan the food for the consumer.
00:19:25:16 - 00:19:47:21
Isabel Hoffmann
This is a Google world, right? I mean, it will be requiring a Google massive amount of investment, which we didn't get. So we had to focus. And we had an employee that had a sister that had a premature baby and she was devastated. She was coming in everyday to work crying.
00:19:47:23 - 00:20:09:01
Isabel Hoffmann
So I start looking at it and I understood that, you know, the hospital was not even doing any fortification because sometimes hospitals do standard fortification. Not even the standard fortification was being done. And so I thought, my God, you know, the problem is that they don't know where to start. Even they cannot measure the human milk.
00:20:09:06 - 00:20:19:19
Isabel Hoffmann
So how can they even start by following some guidelines? And I thought, okay, this is a perfect application for a good sensor. And so we develop our second sensor for creamy applications.
00:20:19:20 - 00:20:28:03
Abigail Acton
Fantastic. Excellent, excellent work as well. Thank you. That's wonderful. Does anyone have any observations or comments to make to Isabelle? Julien Yes, please.
00:20:28:05 - 00:20:48:19
Julien Penders
Great work Isabel. Have a question for you is I would assume that the medical position evolves over time and if that's the case, any thoughts of applying the same technology to kind of continue to help the mom when she goes back home, you know, after the premature kneecap to continue to adapt to fortification based on the changing needs?
00:20:48:21 - 00:21:08:07
Isabel Hoffmann
Yeah, I would hope that that's the case as well, that, you know, eventually the device, because it's very easy to use, becomes in stays in the hands of the mother, even if the mother just brings it from the hospital. But we have to do baby steps to get there because I think, you know, first of all, device has to be certified.
00:21:08:07 - 00:21:32:11
Isabel Hoffmann
Second has to be proven that, in fact, it helps, you know, based on the literature, we can reduce, you know, 4% of occurrence of necrotizing enterocolitis and 4% of bronchopulmonary displeasure, as well as 10% of sepsis. And those are three diseases that these babies really have. But we need much more data in order to have that acknowledge certified by the doctors, accepted by the doctors.
00:21:32:16 - 00:21:50:22
Isabel Hoffmann
And then maybe in a few years from now, I see in all the hospitals having those sensors and the mother either comes in or the mother takes as a rental similar to the breast pumps. You know, I remember when I had my first child, you know, breast pumps not commercially available. And we would go to the hospital to do that.
00:21:50:22 - 00:21:55:06
Isabel Hoffmann
I mean, that's what I envision I envision this to happen in a few years from now.
00:21:55:11 - 00:21:57:01
Abigail Acton
Fantastic. Great, isn't it?
00:21:57:03 - 00:21:57:11
Julien Penders
Thank you.
00:21:57:12 - 00:22:17:17
Abigail Acton
It's fantastic. And it's wonderful. It's lovely to see all these sort of cutting edge technologies being put to such practical applications. Talking of which, Julian, cutting edge technologies, I think we're coming over to you now. The WISH Project enabled BloomLife, the company behind it, to complete the development of a wearable that can help to predict and detect the onset of preterm labor, which sounds just fantastic.
00:22:17:17 - 00:22:33:15
Abigail Acton
So we've been looking a little bit at the impact of preterm birth, and we've been looking at how we can mitigate that with the right nutrition. But how about trying to avoid it altogether? Why premature birth? Julian There are a lot of areas in which telemedicine and wearables are expanding, but you chose to look at the solution. Why?
00:22:33:16 - 00:22:59:10
Julien Penders
Yeah, great question. I think looking at the prenatal period started from my own personal experience. It was actually my wife's first pregnancy was for me an eyeopener on the technology and data gaps that exist today in maternal and prenatal care. So my first case, we were lucky that she ended up having a safe and healthy pregnancy, but I wasn't without much anxiety and uncertainty about how the baby is doing and to do's and don'ts around pregnancy movement, use VR.
00:22:59:11 - 00:23:21:13
Julien Penders
And something said, you know, something could be wrong. And then shortly after our pregnancy, my sister got pregnant and she ended up delivering twins preterm at 33 weeks. And then my two nephews had to spend several weeks in the NICU. It was very emotionally hard for my sister and for me as well. From a distance. And that's really where I started to get interested into preterm birth.
00:23:21:15 - 00:23:40:24
Julien Penders
It was something that technology could do to help detect that earlier or to risk. They take the risk earlier and be able to intervene. If you look at it from a global perspective, you know, my and my sister's case wasn't unique. There are 50 million babies born preterm every year in the world, 1 million of them will not make it to the age of five due to consequences of preterm birth.
00:23:41:01 - 00:24:00:01
Julien Penders
Preterm birth is the number one killer of children under five years old. And that's why I think the innovation that we heard before are great, you know, helping to diminish these numbers. But it's still very important to be able to deal with the consequences afterwards. Okay. From our perspective, replicated in terms of technology, we think that better technology would lead to better data.
00:24:00:01 - 00:24:06:15
Julien Penders
That better data will, in turn, to help us reduce the impact of burden of preterm birth. And that's really where the WISH Project comes in.
00:24:06:17 - 00:24:12:17
Abigail Acton
Okay. So tell me a little bit about the current ways of monitoring mother and baby health and how can they be improved on?
00:24:12:19 - 00:24:33:18
Julien Penders
Yeah, well, I've got to say that maternal health and wellness has in general has long been the land that science forgot. If you look at what doctors use today to evolve technology, it was first introduced in the seventies. It's called the Cogito Program. It's a machine with balance and a big machine next to mom. And again, it's been there for close to 55 years now.
00:24:33:20 - 00:24:49:02
Julien Penders
That means that doctors make very important decisions. So the case of a pregnant mum and her baby, based on very limited data collected during spot checks, visit at the clinics, and that is very much the technology and data gap has that we try to address with the WISH project?
00:24:49:05 - 00:24:52:14
Abigail Acton
Right. Okay. So what did you guys actually develop them?
00:24:52:16 - 00:25:18:11
Julien Penders
So the project was really about developing a wearable sensor that could be used longitudinally during the prenatal period. So it's a patch that is placed on the lower abdomen of a pregnant mum. It measures a bunch of physiological parameters for mum and baby and yeah, it is to use a physiological digital biomarker that we developed during the project to detect the onset of labor or pre-term labor.
00:25:18:11 - 00:25:45:24
Julien Penders
And so the idea is that it was dispatched, a woman can wear it a couple of hours per day. Well, analyze the data based on this biomarker and then we will identify the risk of getting into labor. And that risk then can be shared with the moment, especially her doctor and if the risk goes to high. Then the doctor can be informed about that and you can take into prevention is to actually either, you know, get a mom in if she's already in contractions so that she is okay.
00:25:45:24 - 00:26:06:11
Abigail Acton
So basically that means that the monitoring is done in the comfort of the woman's own home. There is much less stress with regards to not having to go to and from hospital or medical health checkups, etc., etc.. And it's real time. So this sensor collects data and what it's automatically transmitted to the cloud where it can be shared with people who have password access or something like that.
00:26:06:11 - 00:26:07:13
Abigail Acton
How does that work?
00:26:07:15 - 00:26:32:22
Julien Penders
Yeah, that's right. So imagine a device connected by the sensor. It's pre processed on the sensor and then it's sent indeed, in the cloud. In the cloud we have the AI that runs that will extract this physiological marker from the physiological data. And then it will compute a likelihood of a mum going into labor, that information is then shared with the doctor and the mum and dad basically hubs drive possible clinical action.
00:26:33:00 - 00:26:41:19
Abigail Acton
Right. And I believe actually it can perhaps also measure fetal heart rate, which is obviously I think something that will give a woman a lot of reassurance. And also the doctor concerned, are you finding that?
00:26:41:22 - 00:27:01:07
Julien Penders
Yeah, that's some of the work that we've done after the WISH Project, which is really focused on can we identify, you know, early signs of labor onset because of those applications to predict birth after that, we continue the development and once she has the sensor on the lower abdomen, there are many other parameters that we can measure. And one of them is indeed the fetal heartbeat.
00:27:01:07 - 00:27:14:05
Julien Penders
It's kind of the it's the other side of the equation, right? So you want to know when the mum is going to get into labor. You also want to know if the baby's okay. And in fact, our hardware tells you that information. And so the idea is that the technology that we have developed allow us to do both.
00:27:14:07 - 00:27:20:15
Julien Penders
There are ways to have an idea of when the mum is going to get into labor, but also to see if the baby's okay.
00:27:20:17 - 00:27:32:18
Abigail Acton
Okay, That sounds fantastic. And where are you up to with this? I mean this you have prototypes for you in clinical trials. What's the situation? There might be people listening to this right now thinking, Gosh, I want to lay my hands on one of those. But what can you tell them?
00:27:32:21 - 00:27:56:00
Julien Penders
Well, we know we're working as hard and as quickly as we can to get this to market. The WISH project was very important for us because it was really covering the development of that digital biomarker, but also it's validation and prospective clinical trial. So that trial allows us to show that we were able to detect the labor with an equivalent accuracy.
00:27:56:02 - 00:28:17:07
Julien Penders
To a diagnostic of labor, although the mum is home, she doesn't need to go to the hospital. So that was very important for us. Now the next step is really for us to continue the validation of the device and the biomarker get regulatory approval in Europe, CE marking and then eventually be able to to have this technology in the hands of mums and the care team.
00:28:17:08 - 00:28:27:01
Abigail Acton
Fantastic. That sounds wonderful. Really, really good. And I think you already have FDA, that's the American Association's clearance and you're going for a CE mark at the moment and for Europe. Yes?
00:28:27:03 - 00:28:41:17
Julien Penders
Yeah, that's correct. The first FDA clearance was actually for fetal heartrate, this was the first clearance we got. So we still need to work on our clearance for detection, that's in the pipeline. And we are indeed pursuing to get a CE mark.
00:28:41:21 - 00:28:49:15
Abigail Acton
Fantastic. Excellent, Excellent. Thank you. This sounds really innovative. Julian. Super.
00:28:49:17 - 00:29:16:08
Isabel Hoffmann
Yes. When I was listening to you, I was thinking about the fact that some small for gestational age babies, they often show signs that they would have been better off outside of the womb, for instance, because of maternal placental deficiency or things like that. So could you actually use your device to get out babies that are not thriving?
00:29:16:10 - 00:29:37:17
Julien Penders
And it's a it's a great question. We think. Yes. But of course, we still need to do the work to prove that the fundamentally with a device that as it's measure the heart rate of the baby, the heart rate of the mom and uterus contractility. And these are the three parameters that help you get a full diagnostic of what's happening during pregnancy about mom and baby.
00:29:37:22 - 00:30:04:23
Julien Penders
And so with the example of support for gestational age, a fetus is at the stage where indeed some placental disorders or complications will start impacting the baby. You will see that by a decreased level of fetal movement. You can see that by a decrease of activity of the fetus heart rate. These are things that we can indeed measure with the device and using that, absolutely start giving early signs or early indications that something may be wrong.
00:30:05:04 - 00:30:23:13
Julien Penders
So that is absolutely where we want to take this. This is our vision longterm like 5 to 7 years, could we detect early signs of stillbirth? That's really pushing this to the extreme and so the science has to be down there. There is a huge technology gap and data gap in this space.
00:30:23:18 - 00:30:41:18
Julien Penders
And, you know, our first step is to bring the technology that allows us to collect the data. And once we have that data, we can start asking those questions and see, okay, can we see physiological signs for different type of complications and then try to anticipate that? So it's absolutely part of the roadmap. It's you know, it's just so much to do, but we have to start somewhere.
00:30:41:18 - 00:30:45:09
Julien Penders
But yeah, it's a it's a great question. And is something we'd like to do in the future.
00:30:45:12 - 00:31:03:07
Abigail Acton
Exciting times. Julian, exciting times. So basically anything you're doing is going to be moving the whole situation forward rather than taking women regularly into health checks and putting them on to great big monitors where they're. Yeah, spot checks, as you say, is passé now, isn't it? Great.
00:31:04:02 - 00:31:06:13
Abigail Acton
Okay. Well, guys, thank you very, very much for your time. I think the work is just is just wonderful and on all sorts of different levels and how it all comes together, clearly it's an open door into better horizons.
00:31:06:13 - 00:31:15:07
Abigail Acton
This is just really good stuff. Thank you for your time.
00:31:16:12 - 00:31:17:54
Isabel Hoffmann
Thank you.
00:31:18:10 - 00:31:18:50
Audrey van der Meer
Thank you too.
00:31:19:12 - 00:31:20:17
Julien Penders
Thanks again. It was great to be part of this.
00:31:23:08 - 00:31:45:19
Abigail Acton
You're very welcome. If you like this podcast, follow us to make sure that the hottest research and EU funded science isn't passing you by. And if you've enjoyed listening, then why not spread the word? We've talked about insights into how to deal with another pandemic, how augmented reality could save lives in the event of a fire on board ship, and the role of soil bacteria in helping plants thrive.
00:31:46:23 - 00:32:04:01
Abigail Acton
In our last 34 episodes, there'll be something there to tweak your curiosity. Perhaps you want to know what other EU funded projects are doing to mitigate the impact of premature birth and establish new methods of prevention. The CORDIS website will give you an insight into the results of projects funded by the Horizon 2020 Program and Horizon Europe that are working in this area.
00:32:05:03 - 00:32:25:21
Abigail Acton
The website has articles and interviews that explore the results of research being conducted in a very broad range of domains in subjects from Plutarch to plutonium. There is something there for you. Maybe you're involved in a project or would like to apply for funding. Take a look at what others are doing in your domain. So come and check out the research that's revealing what makes our world tick.
00:32:26:23 - 00:32:33:23
Abigail Acton
We're always happy to hear from you. Drop us a line editorial at CORDIS dot Europa dot EU. Until next time.
Insights and ideas
One in 10 children is born before the 37th week of pregnancy – potentially impacting lungs, causing blindness and interrupting the brain’s development. The World Health Organization recently reported there are approximately 6 400 newborn deaths every day, amounting to nearly 47 % of all child deaths under five. Preterm infants have a lower level of nutrient body stores and immature body systems, resulting in a higher risk of malnutrition. Imbalanced complementary feeding could lead to further risk of nutritional deficits and excesses. A mother’s milk is perfectly balanced to feed full-term babies, but when it comes to feeding their premature infants, the milk needs fortification. Given that the contents of the milk can change from day-to-day, and the need of the infant is constantly altering, we hear how sensitive sensors can tell healthcare professionals what nutrients a mother’s breast milk is missing, accurately and instantly. The optimisation of nutrition can help the child to thrive physically, but being born prematurely can have profound impacts on how the child’s brain has developed prior to birth. One of our guests heads a laboratory that is developing ways to identify babies at risk and tailor approaches to stimulate development in the areas that are challenged, on an individual basis. But wouldn’t it be ideal to step in before a woman goes into labour prematurely? A guest tells us how his project is feeding into the development of a wearable monitor that can share data indicating risk with healthcare providers in real time, all while the mother is in the comfort of her own home. Audrey van der Meer is co-director of the Developmental Neuroscience Laboratory and professor of Neuropsychology at the Norwegian University of Science and Technology in Trondheim. She is particularly interested in the infant brain, with its enormous plasticity and capacity to learn from day one, which she explored during the AIM_COACH project. Isabel Hoffmann is a deep-tech entrepreneur. By harnessing technology and connectivity, she is working to help create a world in which food contributes to health, not to societal diseases. Her company Tellspec was behind the Preemie project which is developing innovative ways of personalising nutrition to help premature babies thrive. Julien Penders is co-founder of Bloomlife, a company designing wearable technologies and predictive analytics to promote prenatal health. Bloomlife developed WISH, a device paired with data analytics to increase access to care, provide personalised feedback to mothers, and help doctors predict and manage pregnancy complications.
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Keywords
CORDIScovery, CORDIS, AIM_COACH, Preemie, WISH, premature birth, wearable, neuropsychology, nutrition, monitor