Q&A: How to Use Prolact CR^®
and Maximize Nutrient Delivery

Transcript of the questions and answers from the presentation.

Speaker

Speaker
Stacia Pegram, MA, RDN, LD
Prisma Health Richland
NICU/Special Care Unit

1. Is there a comparison of preterm infant outcomes using Prolacta CR and other market fortifiers?
   
   Response:  No, there have been no studies on Prolact CR with other fortifiers.  There are studies that compare an exclusive human milk diet (EHMD) to other fortifiers that have shown benefits to providing an EHMD over the cow milk based fortifiers, but the studies with the Prolacta CR have focused on using it as part of an EHMD.  However, there are hospitals that use Prolact CR in populations that may need additional energy intake/fat for breastmilk-based feeds versus using a fat modular to avoid adding a non-breastmilk based supplement.  We have used it as a supplement for infants that did not meet our eligibility criteria to receive an EHMD, in which fat losses from breastmilk and/or the caloric concentration of maternal breastmilk were concerns.
2. Can we add a liquid protein modular in addition to Prolacta cream?
   
   Response: I would not add a protein modular to an exclusive human diet because I feel it defeats the purpose of providing a pasteurized breastmilk fortifier if a cow-milk based protein is added to the feeds. The benefits of the exclusive human milk diet may not be replicable if a cow milk-based protein is added to the feed. I also would not think it would be necessary as the Prolact+ fortifiers typically meet estimated protein needs if provided at an appropriate total fluid volume and/or concentration. However, if your question is more specific to tolerance or safety of adding cream, the addition of Prolact CR does not increase the osmolality of the feed and is well-tolerated, so I would not anticipate any tolerance issues.
3. Is this product being used for older infants for increasing calories?
   
   Response: The Prolacta CR was not studied in older infants. However, I would not think there would be an age cut-off if the clinical situation fits the indications for use, such as using it in a breast milk feed to increase calories when it is suspected that the breast milk does not contain 20 kcal/oz, cases of increased energy expenditure, and/or as a fat replacement when there are suspected fat losses from the breastmilk in terms of route of delivery and/or storage.  I would just make certain that the proportion of cream added is appropriate to continue to meet protein needs and provide the desired proportion of energy from fat, protein, and carbohydrates.
4. Can you talk about the maximum amount of cream you recommend giving to a baby?
   
   Response: Our unit usually provides a 2 kcal/oz increase up to a 4 kcal/oz increase. However, if my unit regularly tested the caloric density of maternal breastmilk and knew for certain that maternal breast milk was less than 20 kcal/oz, then we would consider providing whatever was needed to increase that to a 20 kcal/oz in addition to whatever we thought might be needed beyond that.  In my unit, we typically add the Prolact CR to the bottle of Prolact+ fortifier mixed with donor breastmilk or maternal breastmilk as shown in Method 1 that was reviewed in the webinar.  The amount of protein provided, once the cream has been added to the breastmilk/donor milk with Prolact+, is listed in that table. So using the values listed in that table, I make certain that based on the total fluid volume the infant is receiving, I am still able to meet my protein goals.  If I feel like the infant is receiving the Prolact CR due to fat losses from the milk, then I know that my calculations on paper for estimated calorie intake are likely an overestimate because the cream is likely replacing fat that is being lost versus adding additional calories from fat.  However, I always follow weight gain, linear growth, and head circumference to ensure that the infant is growing proportionately.
5. Really interested in how to give CR and can it be given alone at the beginning of a feeding?
   
   Response: The Prolacta CR can be given in several different ways. In the webinar there are four methods discussed. Two of the methods can be used to add the cream to fortified donor breastmilk/maternal breastmilk and two of the methods are specific to unfortified donor breastmilk/maternal breastmilk. The Prolact CR can be given as a bolus prior to the feeding. This method has not been studied, so it is not known how much cream would be needed to “prime” the pump.  However, Method 4 in the webinar and in the cream guidelines shows how to calculate an appropriate amount to bolus based on the desired increase in calories as well as the infant’s weight.  There is another method discussed in the webinar that is not part of the cream guidelines that can be used to determine an appropriate amount to bolus.  This method uses a multiplication factor from Method 2 on the cream guidelines to multiply the total fluid volume that the infant is receiving to provide a certain kcal/oz increase based on that infant’s total fluid intake and then divide the needed volume of cream by the number of feeds received.  If you have difficulty understanding either of these methods, please feel free to contact me and I will be more than happy to walk you through them.
6. Do you support cream boluses or adding cream to feedings to make 34 kcal/oz feedings?
   
   Response:  We have provided cream in addition to Prolact +10 to provide up to 34 kcal/oz in infants that have needed it to grow.  I certainly don’t think that this concentration is necessary for most infants. However, we have needed it in some of our extremely IUGR or SGA infants that are receiving feeds over an extended pumping time, infants that are receiving medications that may impact growth, or infants that have higher energy expenditure secondary to their clinical situation, and/or fluid restricted infant. Unfortunately, there have not been studies that focus on the tiniest of the tiny infants to really determine nutritional needs.  I focus on their growth on the growth chart and z-scores to decide what needs to be done to help that baby maintain his/her growth curve.  Thus, in some cases, we will go to higher concentrations, knowing that they will be better tolerated consisting of solely breastmilk, to promote that growth.  In these cases, I continue to monitor all growth measures to make certain that the infant is growing proportionately.
7. What is the osmolality with cream and how has your unit culture abandoned the idea that cream causes NEC?
   
   Response:  The osmolality of cream is listed on the Prolacta information handouts for reference.  However, the value listed for the osmolality of cream would not be added on top of the osmolality from the feed, but rather included as one of components in the feeds.  The osmolality from the individual products in the feed would be combined and then divided by the total volume.  Thus, if the cream contributes at all (since it is usually dosed in such a small amount), it typically will slightly reduce the osmolality because it is less osmolar than maternal breastmilk/donor breastmilk mixed with the fortifier.  For example, when Prolact +6 is mixed with pasteurized donor milk, the mixture’s osmolality can range from 350-370 mOsm/kg.  When Prolact CR is added, it potentially could change the osmolality by <5 mOsm/kg, so that the final mixture would have an osmolality of 345-370 mOsm/kg.
   
   We have not experienced any NEC associated with cream use, and we use a lot of cream.  Fortunately, due to our fairly routine use and lack of NEC, I have not had this come up in my unit.  There has not been any research that demonstrates an increase in NEC risk with the use of cream. If this is a concern for your unit, I would probably start by reviewing the studies with your unit to see if that will lead to a change in the culture in your unit.
8. Do you have any recommendations on indications for use, any equations that can estimate how much is a loss to adherence in tubing, and practice calculations re: adding if fortification.
   
   Response:  My recommendations on indications for use would include any infant receiving a breastmilk feed pumped over an extended time period, any infant receiving breastmilk or donor milk thought to potentially be <20 kcal/oz (high volume producing mother, skim-like appearance to the milk), any infant with higher energy expenditure than normal (increased work of breathing, cardiac anomaly, genetic disorder, etc), and any infant that is meeting protein needs but experiencing poor growth. Unfortunately, I do not have any equations for estimating how much is a lost in adherence to tubing. I wish I did!  You would suspect that the longer the tubing, the more likely that there would be more fat loss because there is more surface area for which it to bind.  In my unit, we typically use Method 1 to add cream by adding a standard amount for the 2 or 4 kcal/oz to the bottle of Prolact+ mixed with maternal breastmilk/donor breastmilk. I always start with the 2 kcal/oz increase in my unit.  I do have the math calculations for this if you need more information. As for the bolus methods, either method 4 (which is on the cream guidelines) or method 5, which were both discussed in the webinar, have examples to show the calculations.  However, I would happy to work through more calculations with you if that would be helpful.
9. I saw that this past week that researchers were able to create mammary cells outside of the human body that will possibly be able to secrete milk. What are your thoughts on this new biotech? 
   
   Response: I honestly have not heard anything about this. Thank you for bringing it up. It sounds very interesting. I guess we will not know what kind of milk is secreted from “created” mammary cells outside of the human body until it is well studied to really evaluate whether this is comparable to maternal breastmilk.  I would think that maternal breastmilk, if available and safe to provide, would always be the best option since maternal antibodies from the mother that is caring for her infant will be passed down to the infant to help prevent illness. Donor breastmilk or “created” breastmilk will not carry these same antibodies.  I will definitely follow this research.
10. Vitamin supplementation for babies on Prolacta?
    
    Response: We supplement our infants receiving Prolacta, once they are tolerating full volume feeds, with 0.5 mL Poly-vi-sol every 12 hours and provide Ferrous Sulfate separately to provide 2-4 mg elemental Fe/kg/d.
11. Cost analysis as compared to other HMFs?
    
    Response:  Prolacta fortifiers are more expensive than the cow milk-based fortifiers if you are looking at solely at the price tag. However, many hospitals bill for donor breastmilk and Prolacta products. I know my hospital bills for it. We receive a significant amount of money back toward our expenditure. How much reimbursement can be dependent upon each individual hospital’s billing process and state specific standards. I do know that there is someone within Prolacta that can work with your hospital to help with the billing portion of that.
    
    In terms of looking beyond the actual price tag and looking at clinical outcomes, we have found the Prolacta to be more cost-effective because since we started it, we have significantly reduced our NEC rates (which is a huge cost savings), reduced our length of stay, late onset sepsis, and BPD rates.  We have collected data from when we started using the fortifiers in 2009 through 2018. We are currently getting ready to compile our data for 2019.  We just had another hospital system join ours and start using Prolacta. They have been following their data very closely. They have seen very similar results to ours over the past year.
    
    We also initiated Prolact CR as part of a cost savings initiative. We found that if infants are receiving enough protein, then we could use Prolact CR versus increasing to the next level of concentration, which reduced our costs per infant.
12. Is there any significant amount of vitamins or minerals contained in any of the Prolacta products?
    
    Response:  There is product information sheets for each of the fortifiers that lists the average quantities of vitamins and minerals in each of the Prolact+ fortifiers.  The information specific to each bottle is also on the bottle label.
    
    There are pharmaceutical grade minerals added to Prolact+ fortifiers to meet the mineral needs of preterm infants based on the recommended standards that we have. The pasteurization process destroys any added vitamins to the donor breastmilk. Thus, we provide vitamin supplementation to infants receiving maternal breastmilk/donor breastmilk with Prolact + fortifier.
    
    We supplement with 0.5 mL Poly-vi-sol every 12 hours and provide Ferrous Sulfate separately to provide 2-4 mg elemental Fe/kg/d.
13. Is it better to give the cream as a bolus prior to the feed or is it better to mix the cream with the milk and give it together?
    
    Response: I don’t know that one way is better than the other.  It is probably up to the preference of the unit based on what is easiest for the staff that would be preparing the mixed feeds.  In our unit, we typically just mix it with the milk because that was the preferred way for our nursing staff, but I know there are other units that prefer to provide it as a bolus.  The bolus method has not been studied, therefore I do not know if there is any difference in what is provided with the bolus method versus mixing it with the feed.
14. Is there any risk to the intestines during the wean off phase for those who wean off Prolacta to HMF (we do it around 33-34 weeks)?
    
    Response: I would not think that there is any more risk to the intestines in weaning than there normally is in providing a cow milk based fortifier.  Unfortunately, they can’t stay on the Prolact+ fortifier indefinitely, so weaning seems to be safer than just changing to the goal feed all at once.  We follow the transition schedule that is recommended by Prolacta to transition by 2 feeds daily to the goal feed.  Most studies on the exclusive human milk diet have transitioned at 34 weeks. Our unit is a little unusual in that we transition at a weight of 1800 g because that is what the MDs and NNPs felt they could remember. This weight typically falls around the 33 to 34 weeks gestation but in some cases actually extends it until 36 weeks or longer depending on whether the infant is IUGR. If 1800 grams falls before the 34 week gestation and we have concerns about transitioning a particular infant based on his/her history, then occasionally we will extend it until 34 weeks.
15. Any data on vitamins and zinc in EHMD in preterm infants? Ie, availability and adequacy, what vitamin preparation is recommended?
    
    Response:  Additional vitamin supplementation is not added to the Prolact+ fortifiers since the vitamins would be destroyed by the pasteurization process. Pharmaceutical grade minerals including zinc are added to the fortifiers to meet the mineral needs of preterm infants based on the recommended standards that we have. Thus, we provide vitamin supplementation to infants receiving maternal breastmilk/donor breastmilk with Prolact+ fortifier.  We supplement with 0.5 mL Poly-vi-sol every 12 hours and provide Ferrous Sulfate separately to provide 2-4 mg elemental Fe/kg/d.