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Episode 6 - How to Use Prolact CR® and Maximize Nutrient Delivery

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In this Episode:

  • Stacia Pegram, MD, RDN, LD, discusses evidence regarding the use of a human milk caloric fortifier for preterm infants
  • Role of Prolacta’s human milk caloric fortifier as a part of an Exclusive Human Milk Diet (EHMD)
  • Strategies for maximizing nutrient delivery in an EHMD

Bio:

Stacia Pegram, MA, RDN, LD, has been a registered dietitian at Prisma Health Richland Neonatal Intensive Care Unit (NICU) special care unit in Columbia, South Carolina, for 18 years. She has led several NICU nutrition initiatives including developing and managing feeding guidelines, improving quality programs, and educating NICU staff. She is also helping the South Carolina Neonatal Nutrition Consortium develop statewide NICU nutrition initiatives.

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Show notes: Learn more about Prolact CR® Prolact CR® Preparation Guidelines Rogers SP, Hicks PD, Hamzo M, Veit LE, Abrams SA. Continuous feedings of fortified human milk lead to nutrient losses of fat, calcium, and phosphorous. Nutrients. 2010;2(3):230-240. doi:10.3390/nu2030240 Hair AB, Blanco CL, Moreira AG, et al. Randomized trial of human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in infants 750-1250 g birth weight. J Pediatr. 2014;165(5):915-920. doi:10.1016/j.jpeds.2014.07.005 Hair AB, Bergner EM, Lee ML, et al. Premature infants 750-1250 g birth weight supplemented with a novel human milk-derived cream are discharged sooner. Breastfeed Med. 2016;11:133-137. doi:10.1089/bfm.2015.0166 Tabata M, Abdelrahman K, Hair AB, Hawthorne KM, Chen Z, Abrams SA. Fortifier and cream improve fat delivery in continuous enteral infant feeding of breast milk. Nutrients. 2015;7(2):1174-1183. doi:10.3390/nu7021174 Knake LA, King BC, Gollins LA, et al. Optimizing the use of human milk cream supplement in very preterm infants: growth and cost outcomes. Nutr Clin Pract.  doi:10.1002/ncp.10423


Transcript: Keli Hawthorne (KH): Hey y’all, welcome to Speaking of Human Milk, where we give you bite-size episodes on the latest science and innovation surrounding human milk. This podcast is brought to you by Prolacta Bioscience, a company dedicated to Advancing the Science of Human Milk. I’m your host Registered Dietitian Keli Hawthorne. Today, we will be speaking with Stacia Pegram, also a registered dietitian, about what the evidence reveals to us on the use of Prolact CR®, a human milk caloric fortifier in preterm infants, also known as cream. She will also discuss best practices for using Prolact CR and strategies on maximizing nutrient delivery. Stacia currently works at the Prisma Health Richland NICU and has over 18 years of experience as a registered dietitian in the NICU. She is also a member of Prolacta’s Nutrition Advisory Committee, which is made up of NICU dietitians and provides free consultations to NICU clinicians on feeding protocols, their experience with using Prolacta neonatal nutrition products, and growth strategies. Stacia is a great friend of mine as well, and I’m excited to have her with us. Thanks for joining us today Stacia!

Stacia Pegram (SP): Hey Keli, I’m happy to talk to you today on the podcast!

KH: It’s so good to hear your voice. We’ve known each other many years, and it’s always great to catch up with you. SP: Oh same here. It’s been great to get to know you over the years, and talk about different NICU nutrition practices, and how we can always be improving and learning from each other.

KH: I agree! So let’s learn some more today, especially about the cream product from Prolacta. I know you’ve been using it for a long time, and in fact, I’ve nicknamed you the “Cream Queen” (ha, did you know that Stacia?). Can you tell our listeners what the cream product is and how it’s different from other fortifiers?

SP: As you mentioned Prolact CR is a human milk caloric fortifier made from pasteurized human donor milk. What makes this product different from Prolacta’s other human milk-based human fortifiers is that it only contains fat calories and does not include extra protein and minerals. It’s formulated to deliver at least 2.5 Cal/mL.

KH: Let’s talk about preterm infants first. Why should cream be added to the diet of premature infants?

SP: In the premature infant it is extremely important to know that we are delivering adequate energy intake to grow. And what we know about babies born extremely early is that they have missed out on the last months of development that would normally occur in a term pregnancy. Many of their vital organs which includes their lungs and brain now have to continue to develop outside of the womb which requires an increase in energy expenditure. So growth is always important for us to be monitoring. Next, let’s consider human milk. The fat content in human milk is quite variable, not only from mother to mother, but also from one pumping session to the next in the same mother. Because fat makes up the largest portion of calories in human milk, it can really alter the nutritional composition. In addition to the variability in the human milk itself, other factors can reduce the amount of fat that is actually delivered to the premature infant. Many preterm infants are tube fed due to the inability to coordinate the suck, swallow, breathe pattern needed for bottle feeding. Since human milk is not homogenized, the fat from the human milk tends to rise to the top of the feeding container or syringe and adhere there. So when it sits in a syringe as feeds are pumped over time, much of the fat does not make it into the tubing to get to the infant. In fact, I think Keli, you were involved in one of those early studies that looked at this.

KH: Yes, that was a study we did in 2010. Can’t believe that’s already been 10 years ago now. That was a study I did with one of our NICU Fellows at the time, Dr. Stefanie Rogers, along with Dr. Steve Abrams. We compared the nutrient loss of human milk fortified with either bovine-based human milk fortifier or donor milk-based fortifier using 3 different feeding methods: first gravity bolus feeds with the syringes oriented vertically, next we looked at pumped bolus feeds given over 30 min using a MedFusion syringe pump with horizontal orientation, and finally we looked at continuous drip feeds over 3 hours using both a Kangaroo 324 and ePump.

We found that more calcium, phosphorus, and fat adhered to the tubing and wouldn’t reach the infant with the bovine-based fortifier more so than with the donor HM-based fortifier. That was also true regardless of the feeding method – whether that was gravity or infused feeds. When we compared all the feeding methods, we found that the fat loss was greatest with the bovine milk-based fortifier and the Kangaroo pump continuous feeding. Up to 40% of the fat from human milk was lost via continuous feeds due to tubing adherence. We knew that this was a significant reason why our infants on continuous feeds of human milk may weren’t growing adequately.

SP: I’m really glad you did that study and could share the results. Based on this study, I think it is extremely important to consider how much nutrition may be lost from feeds based on the type of fortifier used and the route of feeding delivery. It’s something we talk about regularly in our NICU. Keli, I know that you were involved in all of the major published studies about cream to date. I’m happy to talk about how we put those results to use practically, but if you’d first like to describe the studies that would be great.

KH: Oh sure, that’s perfect. I’m definitely interested in hearing how you interpreted our studies into real-life applications in your NICU. The first study we did was a joint effort in 2014 with Texas Children’s Hospital and University Hospital in San Antonio. We enrolled almost 80 preterm infants, and randomized them to either a control group or the cream intervention group. We analyzed the human milk every baby got on a daily basis in a 24 hour batch.

For babies in the cream group, if their milk was below 20 kcal/oz, we added cream to bring their baseline milk up to exactly 20 kcal/oz. If it was 20 kcal/oz or more, we just recorded it and went on and fed it to the babies as usual and then monitored their growth. Babies in the control group didn’t get any cream, even if their baseline milk was <20 kcal/oz. All babies received the donor HM-based fortifier, and back then we started that when feeds reached 100 mL/kg, although the protocol at TCH is more aggressive now and they start +6 at 60 mL/kg. Overall, we found that the babies who got the cream grew better in both weight and length which makes sense because we were ensuring that they were actually getting at least 20 kcal/oz before adding the HMF for more calories and protein.

Next, we published more data from that same cohort and found that overall, babies in the cream group had a much shorter length of stay. Babies who got cream went home about 2 weeks earlier than babies who didn’t get the cream, and all we changed was just adding the cream which had an impact on their growth and overall length of stay. I also worked with Dr. Abrams and a group of pre-med students at Rice University on a study we published in 2015 about tubing adherence.

We specifically looked at fat loss when cream was added to human milk using a donor HM-based fortifier also. We compared fat losses between 3 groups – the first group was fed plain human milk without any fortification, the second group was given human milk supplemented with donor milk derived HMF at +4 or 24 kcal/oz, and the third group was given human milk supplemented with both donor milk derived HMF at 24 kcal/oz AND the donor-derived cream that we’ve been talking about. We simulated feeds with a MedFusion pump or a Kangaroo ePump over 1 hour. The results showed that donor HM-based fortifier and cream used together can actually increase fat delivery by almost 10% when providing continuous feeds with the Kangaroo ePump or MedFusion syringe pump.

And the last study I’ll mention came out last year, also from Texas Children’s Hospital. We began this study back in 2010 looking at premature babies <1250 g birthweight. The early group that we tracked in 2010-2011 received an Exclusive Human Milk Diet of a donor milk-based fortifier added to mother’s own milk or donor human milk. If weight gain was <15 g/kg/d, then fortification was advanced to the next level of concentration. Group 2 was evaluated from 2015 to 2016 after the cream product was introduced. This group received a similar feeding protocol; however, we gave cream if an infant’s growth velocity was <15 g/kg/d once we were at full fortification with +6 kcal/oz and a minimum of 4 g protein/kg/d.

The results showed that weight gain was similar for both groups even though we often didn’t need to go up to a higher fortifier concentration because we were using cream. The results from the study also showed that there was a significant cost difference between groups, with a relative cost savings of ~$2,300 per patient in the cream group. We believe that the savings were because we were able to use a decreased amount of the donor milk-derived fortifier at higher concentrations like +8 or +10, we were using less than that because we were able to use the cream product instead, and still support adequate protein intakes demonstrated by appropriate growth. So that’s the background. Now, getting back to you Stacia, how do you think these studies helped you and your NICU team to develop guidelines for using Prolact CR?

SP: Our group looked at the data that you all had published and overall I think it can be summed up this way: the use of cream as part of an Exclusive Human Milk Diet has been shown to improve weight and length growth, and has been associated with a decreased length of stay; the use of donor HMF and cream together has been shown to increase the delivery of fat in feedings, and it may help to decrease costs while maintaining growth. That is what gave us the confidence to move forward and start using the product.

KH: And Stacia, when did your hospital start using Prolact CR? SP: Well, we started using Prolacta fortifiers in 2009 and after reviewing your studies and learning more about Prolact CR we decided to begin adding it to our feeds around 2015. We initiated Prolact CR as a cost-savings initiative as you showed in your study. In many cases, we have been able to use the Prolact CR in combination with Prolact+ fortifier to avoid going to the next level of fortifier concentration such as +8 or +10.

KH: When do you decide to use Prolact CR for babies in the NICU? SP: Anytime an infant is placed on a feeding that is run over an extended time period beyond the normal pumping time of 30 minutes, we consider the use of Prolact CR as we know that fat is being lost from the human milk. Currently in our unit, we do not have the ability to analyze every mother’s milk on a routine basis.

We may suspect that a mother’s milk is less than 20 kcal/oz based on the appearance. It may look less creamy, or appear more skim-like. Or sometimes, a mom has a high milk volume and she splits a single pumping session into 2 bottles. She may or may not label it as foremilk and hindmilk so if we suspect that a container is foremilk and therefore lower in calories and fat, then we’d consider using Prolact CR.

We will also consider using it in cases in which high energy expenditure is suspected and additional energy intake is needed. Fat is typically a well-tolerated and easy way to increase the energy provided from a feed.  We make certain that we are meeting protein needs prior to the addition of Prolact CR, but as long as the volume of the breast milk or donor milk with the Prolacta fortifier is adequately meeting protein needs, then we use Prolact CR to improve growth.

KH: And what type of results have you seen in your babies with Prolact CR?

SP: We have seen much better growth outcomes without having to increase the concentration of the fortifier, which has reduced the cost per patient. Our results have actually been quite similar to what was seen in the study you discussed.

KH: And since it’s a product that provides fat calories, I’ve heard cream compared to MCT oil. How is Prolact CR different from providing MCT oil as a way to help make babies grow?

SP: Prolact CR is made from human milk so using it instead of MCT oil allows us to maintain an Exclusive Human Milk Diet, which is what the studies have previously shown to be so protective of conditions like NEC and late-onset sepsis.

KH: I know there are several different ways to calculate and use the cream product, starting with either unfortified or fortified milk. What do you think is the optimal way of calculating the addition of Prolact CR to premature infants in the NICU? SP: As you said Keli, there are multiple ways that you can provide the Prolact CR.  In the original study, the Prolact CR was added to the breast milk to increase the concentration to a minimum of 20 kcal/oz. I’ve worked a lot on the calculations of various ways to add cream to feeds as part of my role with Prolacta’s Nutrition Advisory Council, and we’ve developed a great handout that’s now available for dietitians and other health care providers to help walk them through different ways to calculate cream. First you can think about adding cream to unfortified breast milk.

Basically, there are 2 methods for adding cream to unfortified breast milk. One of those ways is to increase the caloric content of unfortified human milk by a specific number of calories. This method was adapted from the protocol for the study that we talked about previously in which you added enough cream to bring the milk up to 20 kcal/oz. It allows for any volume of milk to be multiplied by a set factor to find the appropriate amount of cream to be added to that volume for the desired calorie increase.

The other method for concentrating unfortified milk is to add a specific amount of cream to 100 mL of unfortified milk in order to obtain the desired caloric increase. Calculations for these different methods are on that handout I mentioned. Next, you can also add the cream to human milk that is already fortified. In this method, a standard amount of cream is added to the 100 mL Prolact + bottle mixed with either mom’s own milk or donor milk to provide either a 2 or 4 calorie increase.

KH: Thanks for sharing all those different methods, and we will definitely provide a link to that handout you mentioned in the show notes. I think it’s great that people can see options and then figure out which method works best for their unit. I typically found that 4 mL of cream added to 100 mL of fortified human milk to add an extra 2 kcal/oz was the easiest way to work with the product and educate my fellow providers in the NICU.

Is it best to start with 2 kcal/oz cream and go up from there, or do you start with more cream than that? How fast do you usually increase the cream volume? Do you have guidelines about when to start it, how much to use, and how to advance?

SP: Well Keli, in our unit we usually start with 2 kcal/oz of cream added to feeds as a general guideline and advance if we don’t see improved growth over time.  In our unit, unfortunately, we do not have a milk mixing room, so we found that the preferred method for our nurses was just to add a standard amount of cream to the Prolact+ fortifier bottle that contains the fortifier mixed with mom’s own milk or donor milk to provide either a 2 or 4 kcal/oz increase.  We don’t have specific guidelines regarding when to start it; however, we do have the clinical scenarios that I mentioned earlier, in which it is often added. Whether we advance to the next level of concentration or provide additional cream following the initial 2 kcal/oz increase depends on the infant’s growth, their total fluid volume, and the protein content of the feeds.

KH: And what about giving a bolus of the cream before a feed in order to help prime the tubing so less fat adheres to the tubing and reaches the baby instead? I’ve heard about some NICUs doing that. SP: Yes that’s another great way that hospitals have used fat supplements in the past – they bolus them immediately prior to the feed. There’s no published data on this with Prolact CR, but it can definitely be delivered in this way to either fortified or unfortified human milk. One important thing to consider with this method is making certain that the dose is appropriate for the size of the infant.

You’d want to be determine how much cream to provide based on the desired percent increase in calories and the individual infant’s weight. Since there are multiple methods to provide cream, NICUs have the ability to select which one works best for their preparation of feedings.

KH: It’s very exciting to see some units priming the tubing with a bolus of cream. I hope the NICUs doing that start publishing some of their data. So it’s interesting to hear that you base the bolus calculation also on the infant’s weight and your desired caloric goals rather than just doing a standard flush, such as with 2 mL of cream. Is there any reason why that wouldn’t work? SP: Even though cream is being used to prime the pump with the bolus method, in reality we do not know exactly how much is needed for that as it has not been studied in this way.  If the dose is based on the infant’s weight and caloric goals, it avoids the infant from potentially receiving too much fat.  A 2 mL dose for an infant weighing 1500 grams may be appropriate, but for an infant weighing 500 grams could be too much, depending on how much fat is delivered to the infant.  Without studies on this specific method of delivery, it is safer to ensure that the infant would be getting an appropriate amount for his/her size if he/she received the full amount.

KH: Do you know if units who are priming tubes with cream or using boluses are counting any of those calories as part of the feeds? And does the length of the tubing make a difference on how much cream to use?

SP: I think it varies depending on the unit.  When it is thought of as priming the pump, then I would say that those units probably do not count those calories.  Since we mix the cream with our feeds, we do count the calories; however, we also know that the infant is likely not receiving that number due to losses, so we don’t worry if that amount is greater than what we might normally calculate for estimated needs. I feel like the length of tubing could definitely make a difference in how much cream to use because the longer the tube is, the more surface area for the fat molecules to attach. Thus, increased tubing length likely results in increased fat losses.

KH: How often do you use Prolact CR? Do you find that you’re using it on just a few babies <1250 g or is it more like half or most of that population?

SP:  We use the Prolact CR quite often; however, it does vary based on the different clinical situations.  Currently, approximately half of the infants receiving Prolacta fortifier in our unit are receiving Prolact CR.  Our use of Prolact CR most likely increases with increased acuity of the infants in the unit.  If we have a lot of infants with a BW <750 g that have more difficulty maintaining serum glucose levels, then we will likely have more extended feeding times; thus, leading to the use of more Prolact CR.  We recently have been using it when we notice calcium and phosphorous imbalances, since we know that more calcium can be lost with fat losses.  For the few infants in which this was implemented, we have noted improvement in those labs following the addition of cream.  We will also use it if an infant is not meeting growth goals despite adequate protein intake which often occurs more frequently with SGA or IUGR infants, as well as the more clinically complicated infants.

KH: From all your experience, about how long do you continue adding cream? I’m sure it’s quite variable and depends on why the baby needed the cream to begin with, but on average, what do you think?

SP:  It honestly does depend on the baby.  Often, we continue it until an infant is ready to be transitioned off the donor milk and/or Prolacta fortifiers.  However, if we notice that the infant’s rate of weight gain is at greater than goal or increasing the infant’s weight for length, and the reason we started it has resolved, then we would discontinue it at that point in time.

KH: When you wean babies off the Prolacta fortifier, do you also wean them off the Prolact CR product at the same time? If not, how do you decide to stop the cream product?

SP: We typically wean it at the same time as we wean the Prolacta fortifier. There might be special circumstances in which to continue it short term in the feed that the infant is transitioned to receiving, but ultimately the infant will need to be on a feed that is available outside of the hospital setting in preparation for discharge home.

KH: Are there any babies that you remember specifically that benefited from the cream that you can share with us about their experience? SP: Yes, we actually have a set of twins currently in our unit that come to my mind as a great example.  One of the twins was receiving a total fluid volume of 160-165 mL/kg/d of breastmilk with Prolact +6 and CR to provide ~28 kcal/oz via gavage feeds pumped over 2 hours secondary to hypoglycemia, but was only gaining weight at 9 g/kg/d.  For this infant, we decided to double the amount of Prolact CR provided to increase from providing an additional 2 calories per ounce to providing an additional 4 calories per ounce.  Since implementation of the additional 2 calories per ounce from cream, the rate of weight gain has improved to over 20 g/kg/d over the past 5 days.

The other twin was receiving the same total fluid volume of 160-165 mL/kg/d with breastmilk with Prolact +6 with no cream as feeds were not being pumped over an extended time period.  However, rate of weight gain was at less than goal at 7 g/kg/d; thus, Prolact CR was started to provide a 2 calorie/ounce increase.  Following the addition of the Prolact CR, the rate of weight gain also improved to greater than 20 g/kg/d.  Our general goal range for rate of weight gain is 18-22 g/kg/d with linear growth at no less than 0.9-1 cm/week.

KH: And because Prolact CR provides fat calories without extra minerals like a traditional human milk fortifier, it can be used in term babies too in order to help improve growth and meet increased energy needs. Can you talk about your experience using cream in bigger or term babies who aren’t growing or have increased energy needs? SP: We have used it in bigger infants that did not meet our criteria to receive Prolacta fortifier. We have used it for those infant’s receiving mom’s breastmilk or donor breastmilk that have had difficulty growing or issues with hypoglycemia.  Since the Prolact CR is so well-tolerated, it is a great product to consider when additional caloric intake is desired.

KH: Are there concerns about using Prolact CR in fluid restricted babies?

SP: This is actually an ideal situation to use cream as long as the infant is meeting estimated protein needs. I can get more calories into the baby using Prolact CR without making a significant contribution to the total fluid volume.

KH: I get asked a lot about “how much is too much”? Is there a maximum amount of cream that is advisable?

SP: Since we don’t analyze mom’s milk, much like most NICUs, we don’t know exactly how many calories are in mom’s milk, and how much are we losing in tubing adherence or when we transfer milk from 1 container to another. It’s really just our best estimation and assumption that it is 20 kcal/oz. It’s quite possible that it’s much lower than that, even 14 or 15 kcal/oz, so when you think about a maximum of 30 kcal/oz for feeds or 10 kcal/oz extra of cream, you may not actually be achieving that. It’s likely lower than what you are estimating. The best rule of thumb is to monitor the baby’s weight of course, but also length using length boards and 2 people to hold the baby while getting that length, and head circumference. Then, see what those trends are over a few days.

KH: Do you have any tips that you would provide to maximize nutrient delivery for infants receiving an Exclusive Human Milk Diet, particularly regarding the use of Prolact CR?

SP:  I would say that as a dietitian, my first goal is always to make certain that the total fluid volume and concentration of the feeds meet the infant’s estimated nutritional needs. If the total fluid volume is restricted, then I will always make certain that the fortifier concentration is adequate to meet both energy and protein needs before I would consider adding anything else.

The next step would be evaluating growth over a few days to determine if the infant is growing adequately on this feeding regimen. If the growth is at less than my goal, then I look at other possible factors that may be contributing such as potential fat losses. Questions that I consider include: Are the feeds being pumped over an extended time period to where I am concerned about fat losses? Are the feeds being provided on a pump with an inverted syringe to help delivery the fat more effectively? What is the appearance of the breastmilk?  Does it have a more skim-like appearance or do I know that this mom produces a large volume of milk at each pumping to where some of the bottles may not be as rich in fat content? Then I also look at the clinical picture of the infant. Is the infant expending additional energy? Are we weaning the oxygen support in which the infant is experiencing increased work of breathing? Has the infant been taken out of the isolette recently in which case additional energy may be used to maintain temperature? Is the infant fighting an infection? In all of these cases, I would consider the addition of Prolact CR to enhance growth and meet nutritional needs.

KH: Stacia, thank you so much for your time today discussing cream and improved nutrition for infants. As we close, do you have anything else that you want to make sure our listeners know?

SP: I’m excited to be working in an era of NICU nutrition where we have options in what we provide to premature and term babies with increased energy needs. It’s great to have confidence in products that are part of an Exclusive Human Milk Diet.

KH: Thanks again for this very informative discussion on Prolact CR. For our listeners, links to information discussed will be available in the show notes, and as always, we look forward to bringing you future topics on the science of human milk.