#433 - 🚀 Can a Wearable Incubator Safely Extend Skin to Skin Duration?

Hello friends 👋

In this Tech Tuesday episode, Ben sits down with Dr. Itamar Nitzan and Alon Meritrikin-Gold, the co-founders of SkinCubator, a revolutionary wearable incubator designed to transform neonatal skin-to-skin care. They discuss how reframing kangaroo care from a rare procedure to a continuous necessity inspired this paradigm-shifting device. The hosts dive into the clinical logistics, from safely transferring intubated extremely preterm infants to alleviating parental anxiety and nursing resistance. Tune in to hear how this innovative "pocket incubator" maintains thermoregulation, secures critical lines, and promises to safely extend skin-to-skin duration for our most vulnerable NICU patients!

Learn more about the skincubator: https://www.skincubator-neocare.com/

Link to episode on youtube: https://youtu.be/T73PaYeXxDw

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The transcript of today's episode can be found below 👇

Ben Courchia MD (00:00.92) Hello, everybody. Welcome back to the Incubator podcast. We're back today for another episode of Tech Tuesday. We're joined today by the team from SkinCubator. We are joined in the studio by Dr. Itamar Nitzan and Alon Meritrikin-Gold, who are the co-founders of SkinCubator. Alon, Itamar, welcome to the podcast.

Alon (00:23.067) Thank you.

Itamar Nitzan (00:23.175) Thank you so much.

Ben Courchia MD (00:25.23) You are both the co-founders. Itamar, you are a neonatologist and you've co-founded this new technology called the SkinCubator, which I find refreshing because if you read the name, you should understand what this is all about. For the people who are not familiar with the SkinCubator...

Alon (00:46.139) You...

Ben Courchia MD (00:50.594) Maybe Alon, do you want to tell us a little bit what this incubator is and what you are trying to achieve with this new technology?

Alon (00:59.565) Firstly, thank you for having us on. This is super exciting. I think it would be helpful. We're going to tell you about the solution. We want to give you a little bit of the clinical context, and to frame the story, it would be helpful to understand how we even arrived at it. Itamar invented the technology. So I'm going to hand it over to Itamar to give the origin of it.

Ben Courchia MD (01:26.08) No problem. Go ahead, Itamar.

Itamar Nitzan (01:26.309) Okay. I did my fellowship at Monash in Australia and my earlier focus back then was functional echocardiography and hemodynamics. I happened to do a study in which we measured the heart function of preterm babies while they were on the mother's chest in skin-to-skin contact and in the incubator. We showed that heart function is better when the baby is on the mom. I was drafting this article when I told myself, Itamar, you did a very nice study, but you didn't understand anything because you can't say that heart function is better when the baby is on the mom. That's the normal place for the baby or for any mammalian offspring to be. So you must say heart function deteriorated when you separate the baby from the mom and put the baby in the incubator. Then I started thinking, unlike all other fellows, I wouldn't say that's great that this baby received two or three hours of skin-to-skin contact today. I would say it's horrible that this baby received 21 or 22 hours of separation in the incubator that reduced his heart function and increased his chances to die or to have adverse neurological outcomes. So I started to think how I can change the situation completely. How can I do a paradigm shift in which we will enable continuous skin-to-skin contact even for extreme preterm babies? Later on, we came to the idea. Now we have the SkinCubator, which is a wearable incubator, but also much more than that. It has an inherent transfer system in which you can transfer the baby within his nest in a midline head position with all tubes, including an ETT or umbilical lines, connected to him. You can transfer the baby within a warm, humidified environment to the mother, open a retractable pad in between them, and have complete skin-to-skin contact even for the tiniest babies. Because it secures...

Itamar Nitzan (03:48.262) ...the baby on the mother, the mother can have her hands outside, she can sleep, and you can do medical procedures. We are basically trying to enable continuous skin-to-skin contact for every extremely premature baby.

Ben Courchia MD (04:02.456) I think that's very interesting. First of all, you've said a lot of things. Skin-to-skin is obviously something that we're all trying to maximize and do safely. There are still a lot of concerns when it comes to performing skin-to-skin. We're not talking about a 36-weeker on room air that's doing well; that remains relatively easy to do. But for these small preemies that have lines and tubes and don't have much reserve, skin-to-skin is a true procedure. It feels dangerous if it's not done well. You've nailed it on the head when it comes to understanding the precarity of the process. I like the reframing you've talked about: not looking at skin-to-skin as just great when you do it as much as possible, but looking at the other side of the coin and looking at separation. How do we frame the lack of skin-to-skin in the form of separation? You've talked a lot about the device itself already. I want to take a few steps back because it's paradigm-shifting, as you said, and it's something that we've never seen before. It's not an iteration of a product that you have in the NICU. It feels like something truly new. The best way that I can describe this—we'll have a lot of pictures and videos on the website for people who want to see how it works and see it in action—is that it is a form of a pocket incubator where the baby can remain in a thermoneutral environment throughout the process, all the while having safe and secure ways to keep all the foreign devices, lines, and tubes safely not moving or being tugged on. Is that an okay description or do you want to moderate that a little bit?

Itamar Nitzan (06:04.987) That was a good description.

Ben Courchia MD (06:06.414) How did you then connect with Alon? How did you guys start working on this? I'm assuming this is an iterative process. You probably worked through a lot of different issues to get to the final product, or at least the product in its current iteration, where it is this form of wearable incubator. How did that happen?

Alon (06:33.765) Itamar and I were connected through a mutual friend more than three years ago. We got on a Zoom and he basically told me the story that you just heard. At that moment I said, you know what? This is a once-in-a-century idea. I dropped everything and joined him. My background is in health projects and medical devices, primarily women's health.

Ben Courchia MD (06:40.301) Mm-hmm.

Ben Courchia MD (06:52.078) Okay.

Alon (06:57.787) I developed a device for sexual assault documentation and did a lot of work in cervical cancer. Basically, if it was depressing, I did it for about a decade. When Itamar came with this idea, I said, this is really something to get behind. We started at a place where we were very curious about heat and humidity management.

Ben Courchia MD (07:05.42) Ha ha ha.

Alon (07:26.939) The initial study was basically around whether we could maintain heat and humidity in a stable way, and we showed that we could. That was the first safety study. When we started presenting it to nurses in the US, Europe, and Australia, we started hearing radically different narratives. A lot of nurses would tell us, what are you talking to us about heat and humidity for? This is not the first thing that's on our minds. On our minds is safety, the dislocation of the tubes, the respiratory equipment—my God, they're taping it to the shirt! The transfer suddenly became a problem. So we needed to take a step back and ask ourselves, what are actually all of the barriers that we're encountering? We mapped them out. We have a very big Excel sheet of the different challenges we were hearing. The purpose of the device, as you said very nicely, was an iterative process. I really want to stress that it was an iterative process in the field. We kept making improvements and going back every time to our NICU partners—respiratory therapists, nurses, neonatologists, and of course, many parents—and just getting their feedback. It's quite challenging with a wearable device. It's not like an app where you change a few lines of code and you can A/B test it. So it was a long process, three years in the works. But now we're seeing that it's landing very well. The nurses, the parents, the doctors, everyone seems to be excited about it and the different functionality. We're quite happy with the results so far. It's definitely a work in progress.

Ben Courchia MD (08:59.534) Absolutely. I want to get to that data a little bit because you do have some on-the-ground feedback. This close feedback loop with the frontline primary users ensured their needs and logistical aspects were addressed. When you think about the SkinCubator, transferring the baby from the bed to the chair is still something that feels unresolved. For many institutions, it's multiple people—five individuals sometimes, maybe two nurses, a couple of respiratory therapists. It's a whole procedure with a lot of risk. Itamar, you alluded earlier that you guys have found a way to make that process a little less stressful. When I was looking at the videos of how this happens, it is very clever regarding how the baby is actually positioned in the SkinCubator. The baby is made ready for transfer, the transfer happens, and then there's a step where the skin-to-skin is effectuated. It's very cool. I wanted to give you the opportunity to describe what that process looks like for the audience.

Itamar Nitzan (10:39.911) The baby can be positioned within his traditional incubator, within the nest of this incubator. The plan—and this is what we did with our last baby—is that this would be the baby's nest. The baby can stay in this nest even when he's in the incubator for the night and the parents are not there. When you want to transfer the baby, you...

...secure all lines and tubes to the nest, which has designated securements for the ETT and for all lines, and you close the retractable pad underneath the baby. The magic is that the retractable pad does not slide underneath the baby, but rather rolls, so each part already touching the baby's skin doesn't move at all. It's done with minimal interference with the baby. It's quite complicated to understand, but when you put your hand on it, it's very easy.

Ben Courchia MD (11:48.854) That's a very important point. People might look at videos and say, well, the pad that comes under the baby looks like it might be sliding. Is that going to cause a burn or rub the skin? But it doesn't slide. It rolls like a roll of tape, basically. Once it makes contact with one square centimeter of the skin, it doesn't move again and just keeps rolling down.

Itamar Nitzan (12:20.423) Yes, there is some sliding motion on the mother, but not on the breast because there is protection. So there is sliding motion of the lower part on the mother, but not of the upper part as it touches the baby's skin. You have very minimal movement of the baby. After you do that, you close the hood upon the baby. You wait a bit until heat and humidity build inside, if it's a tiny baby, and you transfer the baby within this transportable incubator, apply it on the mother's chest, and connect it to a harness that the mother is already wearing. All you need to do is open the retractable pad. It will open in the same manner, where each part touching the baby's skin just rolls down, again with no friction and minimal movement, and the baby is on the mother's skin. The great advantage is that you can easily transfer from one partner to another. We had a mother sitting with a baby with a UVC and UAC for three hours, and then we closed the retractable pad, lifted the SkinCubator, the mother came out, the father came in, and we continued the session. You can do a six-hour session...

...or even more, with a baby with a UAC. The mother can also easily take a break because you can transfer this and put it back in the incubator without opening it. The mother can go to the bathroom or pump breast milk and continue the session. Also, you don't have a minimum duration. Right now we say don't take out a tiny baby if it's for less than an hour or two because you don't transfer the baby through the cold air. With this, you can do shorter sessions if that's all the parents can manage.

Ben Courchia MD (14:07.416) Yeah.

Itamar Nitzan (14:17.319) You don't transfer the baby through the cold air. So you can do even shorter sessions if this is the only thing that the parents can do.

Ben Courchia MD (14:26.178) It's quite incredible. The retractable pad under the baby is removed once the SkinCubator is placed on the parent, and then skin-to-skin happens. The rest of the device looks like an incubator. You have different securing outlets for the ET tube, NG, or OG tube. Then you have these portholes for the parent to get their hands in so they can have physical contact with the baby. It looks like a clear bubble, so the parents can visualize the infant, which we know is so important. What is your record at this time for how long you've been able to do skin-to-skin using the SkinCubator?

Itamar Nitzan (15:25.703) Just last week we had a baby with a UAC. We could recruit the baby based on the local protocol from the beginning of the fourth day of life. On the fourth day of life, this baby had more than six hours of skin-to-skin contact. At day eight of life, the baby had nine hours of skin-to-skin contact. More than seven of those hours were in a row, just with a transfer from the mother to the father.

Ben Courchia MD (15:41.667) Wow.

Itamar Nitzan (15:55.016) If you look at all the weeks in which the baby was treated in the SkinCubator, the baby had an average of five hours per day. For such a tiny 25-weeker, in our unit, it's extremely unique. That never happened before. I also want to add that the parents can have their hands inside through the ports, and there is a window...

Ben Courchia MD (16:16.513) Yeah.

Itamar Nitzan (16:24.794) ...in between the parent and the baby that you can open so they can speak with the baby or even kiss the baby's head. If the baby's too tiny and you need to maintain very high humidity, you can close this window.

Ben Courchia MD (16:37.902) I read a lot about the SkinCubator before seeing pictures, and every question you have when you see the device, you realize, yep, they took care of that. It didn't feel like there was one aspect or concern left unaddressed. You guys took a lot of data we are all familiar with regarding the challenges of performing skin-to-skin effectively in the NICU, like hypothermia or dehydration, and you designed a device that meets all these objectives and allows for safe skin-to-skin. Have you been able to do any trials or studies looking at the effectiveness of this incubator, and what have been the results so far?

Itamar Nitzan (17:33.139) We don't have RCTs yet. We have IRBs ongoing in the United States for such RCTs. What we have currently is anecdotal data that we can compare to historical data. We can see that providing the SkinCubator to the parents at least doubles the amount of skin-to-skin they can perform, doubles the length of the session, and doubles the total duration of skin-to-skin contact. And saying "double" is very conservative.

Ben Courchia MD (18:14.434) Based on the baseline of a particular unit you're testing.

Itamar Nitzan (18:22.992) Yes. And also when comparing it to the parents afterwards when they didn't use the SkinCubator because the baby was larger. Another set of data we have already published shows that it reduces the occurrence of moderate hypothermia that happens when you transfer the baby for skin-to-skin contact. Also, from a mannequin study we did in Australia, nurses feel that the SkinCubator increases the safety of skin-to-skin contact, reduces handling of the baby, and increases the convenience for the nurse. Those are published studies. Some unpublished data that I presented at the jENS conference in Belgrade a month ago shows that when we ask parents to compare their convenience, safety perception, and ability to sleep with the SkinCubator versus traditional skin-to-skin contact, there is statistical significance showing parents feel it is safer and more convenient. They say they would be able to do more skin-to-skin contact.

Ben Courchia MD (19:21.012) It's in Belgrade, that's right. It was in Belgrade a few months ago, that's right.

Ben Courchia MD (19:49.966) I want to make a comment about the parents specifically, but before we get to the parents, I want to talk about the staff. As doctors and nurses, when a parent wants to do skin-to-skin, it's not always met with pure excitement. It's moderated by a little bit of fear: "Let's make sure we do this well, make sure all the staff is available," because a baby that has been doing well could be really stressed from this procedure. But the feedback you're getting from nurses, which you've published on, seems to be very positive. Whenever we introduce a new device or tool in the NICU, the first reaction is usually resistance. So I was very surprised to see this embraced by the frontline workers. Can you tell us more about how the medical and nursing teams responded? Alon, go ahead.

Alon (20:51.459) They didn't embrace it at first. This was a long process. If we had shied away from the criticism or discounted it as conservative nurses, we wouldn't have landed at a place where all the stakeholders are actually excited about using this.

Ben Courchia MD (20:55.928) Hahaha.

Itamar Nitzan (20:56.776) It's how I do it.

Alon (21:21.131) We really have five different users we need to navigate: the baby, the parents, the nurses, the therapists, and the doctors. That's just the immediate surrounding. We invested a lot of thought into how to satisfy all these different needs. I'm sure we're still going to get criticism, and we welcome it. We're going to come out with SkinCubator 4, 5, 6. We're going to keep iterating. It really comes from a place of actively listening because the criticism isn't against the technology. It's the fact that everyone feels a little bit set up. Skin-to-skin care is super important, but we're not giving our nurses, doctors, and parents a lot of tools to do it effectively. We provide a $30,000 incubator, and then here's a blanket and good luck. The resistance was understood. Part of what we're trying to do is hold space for this intervention and give it the infrastructure it deserves. Itamar, you have something to add to that?

Ben Courchia MD (22:23.5) Yeah.

Itamar Nitzan (22:41.691) The fear is correct. The nurses are there to protect the babies, and they are afraid of a new device. But once they do it enough times on mannequins and the process is easy and safe, they feel that it helps them. We refined it many times. The first time we presented it to the nurses in the hospital where we are currently doing the study, they said it could be a good idea, but we needed to improve several things. We came back with a better model and they said, okay, now it's working. We are also collaborating with occupational therapists on exactly how to apply it around the baby, trying to work as much as possible by the NIDCAP approach. You can have one team member accommodate and support the baby while another applies the SkinCubator around it.

Ben Courchia MD (23:35.02) Ha ha.

Itamar Nitzan (24:02.811) Once we refined this process enough, the resistance went down and they saw the advantage. If you see a baby with a UAC receiving six hours a day of skin-to-skin contact, and you know this never happened in your unit for more than one or two hours, then you recognize the great advantage and say you couldn't do it without it.

Ben Courchia MD (24:26.754) I was not surprised to see that once the nurses got familiar with the device in your paper published in the Journal of Neonatal Nursing, their rating of the process was a five out of five on the Likert scale. It makes sense because you were addressing a procedure that is definitely a source of stress for the medical team. The enthusiasm for this device is displayed by the large number of institutions around the world that have joined your research coalition, including centers in Australia, Africa, Europe, and the US. There is momentum from the medical community to experiment with this new technology. But I wanted to go back to the parents. One of the things not always mentioned is that if skin-to-skin doesn't go well, it traumatizes parents. I've been in situations where a baby accidentally extubates during skin-to-skin, and for the next three months, the parents refuse to do it anymore. It takes a lot of work to get them back to a safe place to do it. If we can minimize these potentially traumatic experiences, it alleviates this refractory period. What has been the response from the parents regarding how they felt using this device?

Itamar Nitzan (26:32.489) Thank God we haven't had any accidents, so I can't comment on that. What we really see as an advantage is that it takes the responsibility off the parents. If you put an intubated 25-weeker weighing 500 grams on the mother, attach the tubing to her shoulder, and tell her not to move her hands because moving the baby's head more than one centimeter could cause an extubation, the mother sits there terrified. With the SkinCubator, we take all the responsibility from her. Her hands can be outside, and the SkinCubator secures the baby and the tube. I think we will reduce the amount of extubations, though we need a large RCT to prove this. Even if an extubation happens in the SkinCubator, the mother will feel less guilt because she won't feel it was due to her hands being in the wrong position. Parents are less terrified. When we gave the mannequin to a mother who previously held an intubated baby, she said that with this, she would be calm and unafraid.

Ben Courchia MD (28:31.394) Yeah.

Alon (28:33.303) It really is an experience to walk into the room with a mom who has her intubated baby on her in the SkinCubator. The first thing that struck me was how calm she looked. She just looked like a mom hanging out with her kid, which is not the experience you usually get in the NICU, especially after five or six hours of skin-to-skin with a 25-weeker. It really is striking. If it's okay, I want to make two more quick points about the parents. First, we tested the device on many different body structures—moms, dads, moms with cesareans, engorged breasts—and it was rated as very comfortable by pretty much everyone. Second, we've noticed that dads really take to the device. A nurse jokingly said it's "boys and their toys," but I think it's deeper than that. Dads in the NICU are often at a loss and confused about their role. Having a tool that creates a designated space to "work in" is very comforting on a fundamental level. It clarifies what they need to do.

Itamar Nitzan (30:21.385) We had a dad who told me he was afraid to hold his previous children until they were three months old. He had a 1,200-gram baby, and I transferred the baby to him in the SkinCubator. I told him he could have his hands outside, and there was no responsibility on him—it was just me and the device. We applied the baby on him in the SkinCubator.

Ben Courchia MD (30:32.866) Wow.

Itamar Nitzan (30:48.007) He felt so good about it that afterwards, even when the baby was a bit larger, he confidently did traditional skin-to-skin care. For dads afraid of holding a tiny baby, that's a real advantage.

Ben Courchia MD (31:04.396) We're running short on time. I want to point out that there will be a lot of information on the site. Obviously, as you extend skin-to-skin, the question is what if a baby needs an intervention? You have done a lot of work showing that procedures like blood tests can be done while the baby is in the SkinCubator on the parent's chest. What is the current study you're running, and what are you trying to assess? The data you'll get will be phenomenal. With calmer parents doing skin-to-skin, we might find their vital signs are even more impressive than with traditional skin-to-skin.

Itamar Nitzan (31:55.814) Currently, we're doing feasibility studies in several places to see how nurses work with it in different units. The first RCT we're planning to start soon in the United States is a small study powered to show the increase in skin-to-skin contact time. For later stages, we have applied for grants in Europe and the US for a large study powered to show improvement in neurodevelopmental outcomes. We will randomize babies to receive the SkinCubator or traditional skin-to-skin contact and look at short- and long-term outcomes for those babies and parents.

Ben Courchia MD (32:46.37) The last question I have for you guys today is, what is your current step on your journey to make this accessible to as many NICUs as possible? When can we get our hands on a commercial SkinCubator?

Alon (33:04.059) Firstly, if you want to test the SkinCubator in your unit, you can right now. We have units in Europe and the US that have submitted IRBs to start in a research capacity. We will come to any unit that wants to study it because we want to uncover as much as we can. We're going to have the CE mark to work in Europe by the second quarter of next year. That means in Europe and other locations that accept the CE mark, we're going to be able to start working quite soon. Please reach out; we want to hear from everyone who's interested.

Itamar Nitzan (33:54.499) And we're working on the FDA clearance, definitely, but that will take some more time.

Ben Courchia MD (33:59.053) Basically, if anybody is interested in becoming a pilot partner and testing the device in their unit, there are a lot of opportunities, and we'll have contact information for your team on the episode page. Alon, Itamar, it was a pleasure to talk to you. Congratulations on this impressive work, and we wish you a lot of success.

Alon (34:20.591) Thank you so much.

Itamar Nitzan (34:21.097) Thank you so much.