BACKGROUND: Prematurity occurs when a pregnancy lasts less than 37 weeks; full-term infants are born 37 to 42 weeks after the mother’s last menstrual period. Most of the time the cause of preterm delivery is unknown and it is not something the mother can control. However, sometimes it can be caused by a mother’s health condition or lifestyle choices during pregnancy, like having diabetes mellitus, heart or kidney problems, hypertension, poor nutrition, an infection (specifically infections involving the amniotic membrane and genitals), or bleeding due to abnormal positioning of the placenta. Preterm deliveries can also happen due to structural abnormality or overstretching of the uterus by carrying more than one fetus or using tobacco, alcohol, or illicit drugs during pregnancy. Preterm deliveries occur more often in women younger than 19 or older than 40. However, it could happen to any woman even without risk factors. (Source: http://kidshealth.org/parent/growth/growing/preemies.html)
A PREEMIES BASIC NEEDS: More than 90 percent of preemies who weigh 800 grams or more (a little less than two pounds) survive. Those who weigh more than 500 grams (a little more than one pounds) have more than a 60 percent chance of survival. Preemies have special nutritional needs because they grow at a faster rate than full-term babies and their digestive systems are immature. Most preemies have to be fed slowly because of the risk of developing necrotizing enter colitis (NEC), an intestinal infection. Breast milk can be pumped by the mother and fed to the baby through a tube that goes from the baby’s nose or mouth into the stomach. Breast milk is better than formula for preemies because it contains proteins that help fight infection and promote growth. Special fortifiers can be added to breast milk or to formula because preemies have higher mineral and vitamin needs than full-term infants. Almost all preemies have additional calcium and phosphorus by either adding fortifier to breast milk or directly through special formulas for preemies. The baby’s blood chemicals and minerals, like salt, potassium, blood glucose, calcium, phosphate, and magnesium, are monitored and the baby’s diet is adjusted to keep the substances in a regular range. (Source: http://kidshealth.org/parent/growth/growing/preemies.html)
NEW TECHNOLOGY: Florida State University discovered the Pacifier Activated Lullaby (PAL) device to help address the preemies’ inability to suck. The PAL device helps infants learn the muscle movements they need to suck and feed. Jayne Standley, Florida State’s Robert O. Lawton Distinguished Professor of Music Therapy and inventor of the PAL, says that preemies lack the neurological ability to coordinate the “suck/swallow/breathe” response needed for oral feeding. PAL uses a wired pacifier and speaker to provide musical reinforcement every time the baby sucks on it correctly. Clinical studies at Tallahassee Memorial Hospital, University of Georgia Hospital in Athens, University of North Carolina Medical Center in Chapel Hill, and the Women’s and Children’s Hospital in Baton Rouge, LA proved that infants will increase their sucking rates up to 2.5 times more than infants not exposed to the musical reinforcement. In addition, PAL allows the parents a chance to connect with their babies during the development process. The device is now patented and has been approved by the FDA. Powers Device Technologies obtained the distribution and marketing rights. (Source: http://news.fsu.edu/More-FSU-News/Musical-pacifier-invention-to-help-premature-babies-one-lullaby-at-a-time) The randomized clinical trial at Vanderbilt University paired the PAL device with the sound of the mother’s voice. The study involved 94 NICU infants in the Vanderbilt NICU. The 47 intervention-group received a lullaby book and recorded the mother’s voice to the PAL. The music therapist administered it for 15 minute sessions for 5 consecutive days. The control group received the same lullaby book but did not record their voices. The researchers found that infants in the intervention group doubled the suck rate of oral feeds within five days. (Source: http://clinicaltrials.gov/ct2/show/NCT01600586)
Nathalie Maitre, MD, PhD, Assistant Professor of Pediatrics, Division of Neonatology at The Monroe Carell Jr. Children's Hospital at Vanderbilt, talks about a study teaching babies how to use a pacifier.
Can you explain what the pacifier study is about?
Dr. Maitre: The whole concept of a pacifier is actually very old. Most NICUs have adopted pacifiers to promote non-nutritive sucking. That means sucking where you are not actually getting food, just to learn how to suck. Most of our babies are born preterm and they do not know how to suck. We take it for granted, but it is actually a really hard thing to learn how to do. You have to learn how to not just move the muscles of your mouth, but your brain has to figure out how to coordinate that suck with a swallow and then breathe. We do this all the time, but babies cannot do it. It actually takes a lot of time for the brain to mature, for it to get wired to be able to do that, and so what has been found is that just sucking on a pacifier can teach a baby how to coordinate those muscles and how to swallow basically their own spit. Then, there is a whole other component. Once you learn how to suck on a pacifier, you have to learn how to suck with the right rhythm to swallow that food and to breathe while you are swallowing it, and that is actually really complicated. Our babies’ little brains are not wired to do that yet and the NICU is not exactly a friendly environment to learn how to do that. Some of these babies are in their incubators or in their beds in the Neonatal Intensive Care Unit, so they do not get to learn that. What we are trying to do is teach them how to do it. That is what the study is about.
This is kind of a unique way to try to teach them as well. How did you come up with the concept?
Dr. Maitre: The concept of using a pacifier activated music player is not new. The device actually was made by a company. What is really new is that we decided the best stimulus for a baby’s brain bar none is mom; mom’s voice, mom’s touch, mom’s smell, mom is what helps a baby develop. Being inside mom is what helps them develop. So, we thought instead of just playing music, what if we used that most powerful stimulus which is a mom’s voice and we combine it with this device. If you think about it, a baby is like a tiny, beautiful little animal and just like any animal they can be taught how to do things. In this case, what we are doing is wiring a baby’s brain to understand how to feed using mom’s voice, the most powerful stimulus, combined with music therapy. Moms actually sing lullabies and this will teach their baby how to learn how to suck and the right way to feed. It is pretty incredible because you can see a baby’s response almost after one 15 minute session. If the baby is sucking at the right rhythm and strength, the pacifier plays mom’s voice singing. If it is not at the right rate to get effective suck, it stops and the baby experiences the absence of mom’s voice. What is great is that even when moms are not there, we are able to do it. Most moms obviously want to be involved and the best thing about this to me is that we are all about family-centered care, and this is family-centered care pushed to the extreme. It is like saying “mom, you are going to teach your baby how to eat even though his little brain is too immature to understand it yet”. When you are a parent in the NICU, there are so few things that you can actually do to help your child. There is Kangaroo Care or “skin to skin” care, and now there is this music therapy intervention. Mother’s voice used to do this, makes us all feel really good about this study.
What were the results that you saw in the study? How many kids were in it?
Dr. Maitre: There are going to be a total of 94 babies and they were randomized, which means we allocated them randomly to two groups; one group in which moms did this intervention. We recorded the moms singing lullabies and then used a USB drive with their voice in the device. The babies get 5 days of 15 minutes a day of this training with our music therapist. After that time there is no longer any intervention and they are allowed to eat like any other baby. Then, in the other group we still want to encourage moms to sing and be with their babies so we gave them the same set of lullaby books that we give to the moms in the other group, because a mother’s voice is important, not just through this device. In terms of the design it is based on the same principles in Pavlov’s dog experiment basically. Simply put, in Pavlov’s dog experiment, if you rang a bell at the same time you fed him, over time you could just ring the bell and the dog would know there was food. It is called operant conditioning with positive reinforcement. Positive reinforcement in this case is mom’s voice and the conditioning is the device. Positive reinforcement is always better than negative reinforcement. If you have children, you know this. You could punish them and it will never be as effective as praising them, and so that is the basis of this intervention. We have these two groups and what we found, which is incredible, is that this kind of training using mother’s voice singing and this pacifier activated device has resulted in shorter hospital stays and it varies anywhere from one day to sometimes two weeks. We know this because the babies are actually going home smaller, meaning they can feed faster. They are more mature that way and they can go home even though they are a little bit smaller than the babies in our control group. We can also measure how fast they suck, called their suck rate, and we can show that even after a week of this training they are sucking much, much faster. They take about two to three times less time to eat the same amount of food. That does not seem like it is important, but it is, because when you are a baby, eating is like running a marathon; it is incredibly hard and it takes up a lot of energy. If you can shorten the time that you have to run your marathon, you are going to expend less energy eating and more energy growing, developing your brain, and maturing your body; that is one of the things that normally keeps babies in the NICU. These babies are able to feed faster and better.
So, they feed faster but still weigh less when they go home because they are going home earlier?
Dr. Maitre: Right. In order to leave the NICU, a baby has to meet three conditions apart from the main one, which is that they have to be stable and breathe on their own. The other conditions are they have to be able to grow and put on weight every day, they have to be able to feed on their own without a tube and too much assistance, and they have to maintain their temperature while doing so. All three of those things mean a baby has to be able to use the energy it is getting to maintain all its normal functions and still grow; that is what it amounts to. What these babies are doing is they are still growing and still maintaining their temperature, but now they can feed on their own faster. So, they are going home at a little bit smaller weights.
Are they stronger or is that the suck rate is better?
Dr. Maitre: There are ways of testing how strong they are, but that device does not let us really know. It lets us know the threshold, so it does tell us how strong they are in terms of the pressure they can exert to get the device going. The device actually records all that and it also can tell us how fast they are going. It is not how strong their entire body is just how their suck is doing.
What are the effects of being able to go home earlier?
Dr. Maitre: If you have been in the NICU for three months, believe me, the stress and anxiety of being in the NICU with a baby is just horrendous. Also the loss of control; if you are a parent in the NICU, there is very little control you have and you just feel like everything is happening to you instead of you helping out. First of all, it is a way to empower moms to be able to help their babies and regain a little bit of that control. It lessens the anxiety, but then if they can go home earlier they get what their life is really going to be like in their home environment with their family support and it is better psychologically. It has also been shown that once babies are home they can eat better than they do here, but mainly they grow better and then are at much less risk of infection. Hospital-acquired infections are obviously one of our main concerns and every day that a baby is not in a hospital is one less day that they risk getting an infection. Even in the NICU, which is obviously one of the most sterile environments and where people are very cautious, we are still always worried about these little babies. They are so vulnerable.
What is the plan for this now?
Dr. Maitre: We are three-quarters through the study which is why I can talk about the results. We only have ten more patients to enroll right now out of the 94. We are very confident about our results and we are very happy. The whole point would be to incorporate this for every baby who meets the criteria, which right now is pretty much any baby whom the medical team feels is ready to eat.
Could you see this expanding to other hospitals as well?
Dr. Maitre: I think we need to publish those results first. It is every hospital’s decision. Vanderbilt thinks that music therapy is incredibly important. I mean we are in Nashville, which is Music City! Music therapy here is considered a medical intervention that is based on neuroscience. Not every institution has a music therapist that is medically trained like we have and not every institution uses music therapy for that purpose. A lot of institutions use it more as a comfort tool, a play therapy. We are very passionate here about the fact that music can help rewire the brain, and so that is a little bit different slant on things. Certainly we cannot say that every institution would feel that way.
So is the technology out there right? I mean if they want it, they can get it?
Dr. Maitre: Yes. You just need to adapt it, and in this case the moms have been incredibly responsive. There is always that part where they say “oh, I can’t sing”. The answer is:” your child will love your voice; you can sing for your child.”