Obtaining and Using Donor Milk in the NICU

1. Karen Strube RNC-OB, IBCLC Lactation Program Coordinator Wheaton Franciscan Healthcare All Saints Obtaining and Using Donor Milk in the NICU

2. Objectives – Following this presentation you will be able to: • Describe the benefits of using donor milk for preterm or ill infants. • Identify the infant who would benefit from the use of donor milk. • Discuss with parents how donor milk is used in the NICU and the process for becoming a donor. • Describe the process for obtaining donor milk from a HMBANA milk bank.

3. Mother’s own milk is preferred for infants in the NICU • Every mother should be informed about the importance of her own milk for her infant – this information should be provided; prenatally, antepartum, or post partum – we don’t “badger mothers” or “talk them into it” – we provide accurate information, document and communicate the mother’s wishes. • For the critically ill/small infant we are not asking the mother to “breastfeed”. After providing the appropriate information use the phrase “your milk is important medicine for your baby – would you consider providing pumped milk for your baby?” • If the mother is unable or does not desire to provide her own milk the MD will discuss and obtain the consent for use of donor milk.

4. Why Donor Milk? • Reduce NEC, Sepsis, Length of Stay • Decrease Mortality • Lead the way! Only a handful of Wisconsin hospitals currently use PDHM. • Increase patient satisfaction • Reduce healthcare costs and improve long term outcomes • Increase RN/MD satisfaction by decreasing cases of fulminant/surgical NEC

5. Recommendations “Growing evidence supports the role of donated human milk in assisting infants with special needs, such as infants in newborn intensive care units who are unable to receive their own mothers’ milk, to achieve the best possible health outcome.” US Surgeon General (2010) “Where it is not possible to breastfeed, the first alternative, if available, should be the use of human milk from other sources. Human milk banks should be made available in appropriate situations.” WHO/UNICEF (1980)

6. Recommendations Continued “Banked pasteurized donor human milk has been found to be safe and nutritionally sound for babies who do not have access to their own mothers’ milk” American Academy of Family Physicians (2008) “Banked human milk may be a suitable feeding alternative for infants whose mothers are unable or unwilling to provide their own milk. Human milk banks in North America adhere to national guidelines for quality control of screening and testing of donors and pasteurize all milk before distribution.” American Academy of Pediatrics (2005)

7. Recommendations Con’t. “ABM Accepts and Endorses (the) Human Milk Banking Association of North American, Position Paper on Donor Milk Banking.” Academy of Breastfeeding Medicine Position on Breastfeeding (2008) “The value of human milk in reducing the incidence of NEC has influenced the growing use of pasteurized donor human milk for infants at high risk for NEC. When mother’s milk is not available, providing pasteurized donor m ilk from appropriately screened donors from an approved milk bank offers immunoprotection and bioactive factors not found in infant formula and is the next best option particularly for ill or preterm infants. Only human milk from facilities that screen and approve donors and pasteurize d the milk should be used because there is risk of disease transmission to the recipient from donors who are not screened and from the use of unpasteurized milk.” American Dietetic Association. Promoting and Supporting Breastfeeding. J Am Diet Assoc. 2009; 109:1926-1942

8. In 1985, the Human Milk Banking Association of North America (HMBANA) was established to provide evidence-based guidelines and standards for the industry. • HMBANA milk banks are non-profit. • There are currently 14 milk banks in operation or being developed in the United States. • Until the WI/IL milk bank is operational we order from The Milk Bank of Indiana.

9. HMBANA Locations Operating Milk Bank Developing Milk Bank

10. Developing Local Milk Bank • The Mother’s Milk Bank of the Western Great Lakes is a developing HMBANA milk bank. This bank will serve Illinois and Wisconsin. • The milk bank will increase awareness, leading to increased utilization of PDHM. • Milk donations from Illinois and Wisconsin mothers will be used for local at-risk infants.

11. All Saint’s Milk Depot • We have been shipping milk since April. • Qualified donors are able to drop off milk to the lactation office for shipping to the milk bank.

12. Milk Donor Screening Process To become a milk donor, follow the below steps to complete the simple screening process. 1. Learn how to donatethrough the Indiana Mothers’ Milk Bank (IMMB) or call them at 317-536-1670 or toll free at 877-829-7470. 2. The IMMB will explain its qualifications for milk donation. After you complete their screening process, they will instruct you to contact us by phone at 847.444.9256 or e-mail info@milkbankwgl.org. 3. The IMMB will arrange for your blood testing, at no cost to you. The screening process takes approximately 2-3 weeks to complete. When you are approved as a donor, please make arrangements to drop off your milk at the closest milk depot in Illinois or in Wisconsin. Feel free to contact our Executive Director by phone at 847.444.9256 or e-mail info@milkbankwgl.org.

13. Donors • Are healthy lactating women. • Are mothers with an abundant milk supply or grieving mothers who donate their baby’s stored breast milk. • Must consent to blood tests for : HIV, Hep B, Hep C, Syphilis, and HTLV. • Must obtain medical clearance from physician. • Must complete lifestyle and health questionnaires (similar to blood donors). • Can only take a few approved medications - determined by the milk bank

14. Requirements for Donation It is important to follow the milk collection and storage procedures described by the IMMB. We request that you plan to donate a minimum of 100 ounces over the course of your time as a milk donor. Exceptions to this minimum are made for bereaved mothers.  We can accept milk you stored before contacting us as long as: 1.  You were not ill and/or taking any non-approved medications. 2.  Your frozen milk has been in a refrigerator-freezer for less than 3 months or in a stand-alone deep freeze for less than 4 months. 3.  Your milk is stored in clean, food-grade containers. After your first donation, you may donate your milk in any amount until your baby reaches 2 years of age.  Milk storage containers are available at many of our milk depots when you drop off milk.

15. Bereavement Donation • Stored breast milk represents the mother’s love love and devotion to her baby. • The milk symbolizes the baby. • Mothers “cannot bear to throw away the milk.” • Milk donation allows these moms to continue to mother and nurture by helping other babies in need. • This donation honors and memorializes their baby. • There is NO minimum donation. • Mothers who do not qualify due to medications/or history can still donate milk for research. • Our lactation staff can help support these mothers through the donation process.

16.  Letter to Mother Please accept our deepest sympathy for the loss of your baby. We respect hat this is a sad time for you and your family. As a mother who pumped milk for her infant, we appreciate the dedication and love you put into pumping your milk. You may have unused milk that is stored in a freezer at the hospital or at home. Some mothers take comfort in donating their stored milk to a milk bank. Milk banks can process the milk and send it to neonatal intensive care units where it can be used by premature or sick babies. The NICU at Wheaton Franciscan Healthcare – All Saints has partnered with The Milk Bank of Indiana to help mothers who would like to donate their stored breast milk. If you would like to donate your stored breast milk, we can help you with what is needed to send the milk to the Indiana Milk Bank. In honor of your donation, The Milk Bank of Indiana will have your baby’s name engraved on a leaf on their “Giving Tree” memorial. We respect that you may need time to think about donating your stored milk, know that you can contact us at any time to talk about milk donation or any breast concerns, and return of the rented breast pump. We will keep your stored milk safe at the hospital for up to four weeks. During this time you can choose to donate, pick up, or have us discard it. We will support and honor any decision you make regarding your stored milk. Our thoughts are with you. Sincerely,

17. Milk Processing Scrubbing Pooling

18. Milk Processing Pouring Pasteurizing

19. Milk Processing Labeling Microbial Testing

20. Holder Pasteurization • Milk is pasteurized in a shaking water bath or automatic pasteurizer for 30 minutes at 62.5° Celsius. • This method of pasteurization destroys HIV and CMV*. * www.latrobe.edu/au/microbiology/table7.html

21. Bacteriologic Testing • After pasteurization, one bottle from each batch is sent for culture. If there is any growth, or contamination, the entire batch is discarded.

22. NEC: Feeding Issues • Infants fed PDHM experienced fewer episodes of feeding intolerance and diarrhea.1 • Infants fed high proportions of human milk achieved 100 ml/kl/d enteral feedings 4.5 days faster, and 150 ml/kl/d 5 days faster than the low human milk group.2 1. Boyd et al., 2007 2. Sisk et al., 2008

23. Other outcomes associated with human milk feedings for premature infants: • Reduced incidence of sepsis • Shorter length of stay • Decreased incidence of ROP • Improved developmental outcomes Ronnestad et al., 2005

24. Indications for PDHM • Birth weight equal to or less than 1500 grams • GI diagnosis (short-gut syndrome, hirschsprungs, malabsorption, GI surgery) • NEC or a history of NEC • Renal failure • Feeding intolerance • Some inborn errors of metabolism

25. So how did we get the process going? (refer to handouts) • Progression to use of PDHM • Guideline for the use and storage of pasteurized donor human milk (PDHM) in the NICU • Consent for use of PDHM • Loss Letter

26. Ordering Donor Milk Pasteurized donor human milk is dispensed by prescription only. The highest-priority recipients are premature and ill hospitalized infants. All infants who have a medical need for human milk can obtain donor human milk by prescription. Until the processing and distribution facility of the Mothers’ Milk Bank of the Western Great Lakes is operational, pasteurized donor human milk can be ordered from our Mentor Bank in Indiana. Indiana Mothers’ Milk Bank4755 Kingsway Drive, Suite 120Indianapolis, IN 46205Phone (317) 536-1670Toll-free 1 (877) 829-7470FAX (317) 536-1676 Contact: Janice O’Rourke, Executive Directorjorourke@immb.org

27. Guidelines For Use of PDHM • Need Physician Order • Need parental consent prior to use • Will start MEF’s on day one of life • Premature infants will receive Preterm PDHM/Term milk for 4 weeks. (Preterm milk is rarely available) • All infants will transition to “Term” milk after 4 weeks of life, or if they are >34 weeks. • Infants will wean after 4 weeks, when they attain 1500 grams. • Infants will not go home on PDHM, they will be weaned to formula. • Infants may receive additional PDHM if they experience feeding intolerance

28. The Process • The lactation office will assess the stock of PDHM daily/weekly and keep a minimum of (10) 4oz bottles kept on hand. • PDHM will be ordered by the materials management coordinator, shipped by FedEx and will not be delivered on Saturday or Sunday. • Shipments will be received at the NICU front desk – if the LC (lactation consultant) is working, she will be paged to assume responsibility for the milk, if unavailable the charge nurse will sign for the milk. Only if the charge nurse and LC are unavailable is the unit clerk to sign for the milk. • The person signing for the milk will check the milk against the invoice, assess the condition of the milk and transfer the milk to the freezer in the nutrition room.

29. Process Con’t. • If the shipment does not match the invoice, or if there is a problem with the shipment (broken bottles or thawed milk), the person receiving the milk will contact The Milk Bank of Inidiana immediately. • The milk will be logged into the Donor Milk Receiving Form in the PDHM Log Book kept in the Nutrition Room • PDHM will be stored in accordance with the current HMBANA guidelines – in the NICU freezer for 6 months (all milk is stickered with an expiration date). • PDHM must be used within 24 hours of thawing.

30. Preparation and Feeding • A single “Unit Bottle” of PDHM can be used for several infants. The bottle will be labeled with the date/time of initial thaw. Several bottles or syringes can be prepared from the “Unit Bottle”. Please draw up only what is needed so there is no wasting of PDHM. • The unit bottle will be thawed in accordance with our breast milk policy. The bottle will be thawed to cold, not room temperature. • The unit bottle will be labeled with a “Date/Time Thaw” label. This label will contain the date and time of initial thaw. The original label from the milk bank will NOT be removed. • The unit bottle will be stored in a designated PDHM refrigerator in the NICU Nutrition Room. • The RN will pour the desired amount of PDHM into a volufeed. She/he will recap the unit bottle and return it to the PDHM refrigerator. She/he will draw up feedings into syringes or distribute the PDHM into bottles in the infant’s pod. Syringes will not enter the unit bottle. The RN will pour the desired amount of PDHM into a volufeed first, and then draw up MEF’s from the volufeed (not from the unit bottle).

31. Preparation and Feeding Con’t. • You may prepare one or several feedings for the same infant (up to the expiration time of the milk). • Label each syringe/bottle with the infant’s sticker and identify the milk as PDHM. • PDHM can be fortified as per current NICU protocol. • Enter the infant’s name and milk lot# on the PDHM log, which will be kept in the PDHM Log Book in the NICU Nutrition Room. • Chart the feeding as “Donor Human Milk” and include the donor milk# in the EHR. • All Forms/Logs must be retained 20 years! When forms are complete - give to the NICU Manager

32. PDHM Log Book Pasteurized Donor Human Milk (PDHM) Log Book Wheaton Franciscan Healthcare – All Saints St. Luke’s Health Pavilion NICU (stored in Nutrition Room)

33. Log Book Contents • Guidelines for the use and storage of pasteurized donor human milk in the NICU • Information/Consent for Heat Processed Banks Donor Human Milk • Donor Human Milk Receiving Form/Log • Donor Milk Usage Form/Log • Donor Human Milk Recall Form/Log • Date/Time Thaw Labels

34. Donor Human Milk Receiving Form/Log

35. Donor Milk Usage Form/Log

36. Donor Human Milk Recall Form/Log

37. Challenges Along the Way Keeping enough milk stockedAvoiding Wasted MilkClarification of policyDonor Milk vs. Mother’s Own Milk Storage guidelinesWho does what? RN, Lactation Consultant

38. What’s next………… • Introduction of the Milk Tech Role • Using donor milk for hypoglycemic infants. • Using donor milk in any breastfeeding infant who us unable to breastfeed until mother’s milk supply is established. • Establishing the ability of donor mothers to drop off milk donations at any Wheaton facility to be transported to All Saint’s Depot and shipped to the Milk Bank

39. A powerful statement… “Substantial clinical evidence has placed human milk feeding and donor human milk as a basic right for preterm infants…Banked donor milk should be promoted as a standard component of health care for premature infants.” Arslanoglu, Ziegler, & Moro., 2010

40. References • Arslanoglu,S., Ziegler.E. E., Moro, G. E. (20210). Donor human milk in preterm infant feeding: Evidence and recommendations. Journal of Perinatal Medicine, 38(4), 347-351. • Advocate Medical Group Section of Neonatology (2010). Guideline for the use and storage of pasteurized donor human milk in the NICU. • Arnold, L.W. (2002). The cost effectiveness of using banked donor milk in the neonatal intensive care unit: Prevention of necrotizing enterocolitis, J Human Lact, 18(2), 172-177. • Boyd, C.A., Quigley, M.A., & Brockelhurst, P. (2007). Donor breast milk versus infant formula for preterm infants: Systematic review and meta-analysis. Ach Dis Child Fetal Neonatal Ed, 92, F169-F175. doi: 10.1136/adc.2005.089490. • California Perinatal Quality Care Collaborative (2008). Quality Improvement Toolkit: Nutritional Support of the Very Low Birth Weight Infant. • Edwards TM, Spatz DL (2012). Making the case for using donor human milk in vulnerable infants. Advances in Neonatal Care (2012) 12(5), 273-278. • Ewaschuk JB, Unger S, Harvey S, O’Connor DL, Field CJ. (2011). Effect of pasteurization on immune components of milk: implications for feeding preterm infants. Appl Physiol Nutr Metab. 2011 Apr;36(2):175-82. Department of Agricultural, Food, And Nutritional Sciences, University of Alberta, 4126 HRIF East, Edmonton, AB T6G2E1, Canada. • Human Milk banking Association of North America, Inc. (2011). Best Practice for Expressing, Storing and Handling Human Milk in Hospitals, Homes and Child Care Settings. 3rd Edition.

41. References Continued • McGuire, W., & Anthony, M.Y. (2003). Donor human milk versus formula for preventing necrotizing enterocolitis in preterm infants: Systematic review. Arch Dis Child Fetal Neonatal Ed, 88, F11-F14. • Meinzen-Derr, J., Poindexter, B., Wrage, L., Morrow, A. L., Stoll, B., & Donovan, E. F. (2009). Role of human milk in extremely low birth weight infants’ rick of necrotizing enterocolitis or death. Journal of Perinatology, 29, 57-62. • Miracle Dj, Szucs KA, Torke AM, Heft PR. (2011). Contemporary ethical issues in human milk-banking in the United States. Pediatrics, (2011);128;1186-1191. • Ronnestad, A., Abrahamsen, T.G., Medbo, S., Hallvard, R., Lossius, K., Kaarensen, P. I., Markstad, T. (2005). Late-onset septicemia in a Norwegian national cohort of extremely premature infants receiving very early full human milk feedings. Pediatrics, 115(3), e269-e276. doi:10.1542/peds.2004-1833. • Sisk, P.M., Lovelady, C.A., Dillard, R.G., Gruber, K.J., & O’Shea, T.M. (2007). Early human milk feeding is associated with a lower risk of necrotizing enterocolitis in very low birth weight infants. Journal of Perinatology, 27, 428-433. • Sisk, P.M., Lovelady, C.A., Gruber, K.J., Dillard, R.G., & O’Shea, T.M. (2008). Human milk consumption and full enteral feeding among infants who weigh less than or equal to 1250 grams. Pediatrics, 121(6), e1528-e1533. doi:10.1542/peds.2007-2010. • Underwood MA. (2013). Human milk for the premature. Pediatr Clin N Am 60 (2013) 189-207. • Wright, N.E., Morton, J.A., & Kim, J.H. (2008). Best Medicine: Human Milk in the NICU.

42. Thank You Summer Kelly, RN, BSN, IBCLC (Mothers’ Milk Bank WGL) for content, slides and support during this process. Mothers Milk Bank of Western Great Lakes Wisconsin Association of Lactation Consultants The Milk Bank of Indiana