Donor Human Milk Banking Anne Eglash MD IBCLC

Donor Human Milk Banking Anne Eglash MD, IBCLC, FABM Arlinda Michael RN, BSN IBCLC

Objectives • Know 3 benefits of donor human milk. • Understand the history of donor milk banking in the USA. • Learn the steps taken by a woman to donate her milk, and how the milk arrives and is processed at the bank. • Identify the key responsibilities that hospitals must take in receiving, storing, and using banked donor milk.

Breastmilk is 1 st Choice for VLBW Infant (Cochrane 2010) • • • Faster GI emptying Faster attainment of full enteral feedings Improved gut growth and maturation Decreased risk of NEC and LOS Improved neurodevelopmental outcomes Less ROP, improved visual development

Preterm vs Term Mothers Milk Cochrane 2010 • Differences in: – Protein, fat, carbs – Digestive hormones – Growth factors – Immunological factors – Vitamins, minerals, trace elements – LCPUFAs

What is Pasteurized Donor Milk • Women with extra milk contact a milk bank. • The potential donor is screened via interview and blood testing. • If accepted as a donor, her milk is donated to a milk bank. • The milk is tested, pasteurized, retested for contamination, and shipped to hospitals and outpatients who need human milk.

History of Human Milk Banking in the USA • Marketing of artificial feeding products started in the late 1800’s, with general acceptance of formulas as first choice by the 1950’s in the US • Always has been a movement interested in donor human milk for ill or premature infants • AAP published its 1 st recc for human milk banks in 1943 • Many other countries around the world established milk banks. HMBANA was established in 1985 to provide standards for human milk banks in NA. • In the mid-1980’s, due to HIV, the majority of the milk banks closed. • In the 1990’s, interest has resurfaced with evidence of safety and research on the health benefits of human milk. • In 2010, there are 9 human milk banks in the US, and 1 in Canada, and 6 developing milk banks in the USA (not including WI-IL)

Why Use Donor Milk? • IF mother’s milk is not available, are there benefits of pasteurized donor milk, vs use of formula? – Infection risks with donor milk? – Quality after pasteurization? – Cost prohibitive? – Can pasteurized donor human milk provide the same protection of illness as mother’s milk?

First the Bad News

Concerns about Donor Human Milk for Preterm Infants • • • Insufficient Pro, Ca, Phos, Na, Vits Variability in composition, and often term Changes in nutrients with processing and storage Bacterial contamination with processing Bacterial contamination during storage and feeding Wight HMBANA conference 10/05

Immunobiological Activity of Human Milk Hanson, L Immunobiology of Human Milk 2004 • Proteins – SIg. A (enteromammaric link) – Bind microbes on mucosal surfaces, fewer invasive infections – Permit normal bacterial colonization in gut – Lactoferrin- glycoprotein – Iron binding protein – Bactericidal and anti-viral – Alpha lactalbumin – Binds as a large complex with oleic acid to induce apoptosis of malignant cells – Lysozyme – Antimicrobial properties in cooperation with lactoferrin and SIg. A

Immunobiological Activity of Human Milk Hanson, L Immunobiology of Human Milk 2004 • Carbohydrates – Oligosaccharides – Affect composition of the infant gut bacterial flora, and block mucosal attachment of microbes – Glycoproteins and Glycolipids – Block adherence of bact and viruses to epithelial cells • Lipids and Milk Fat Globules – Free fatty acids are anti-microbial – Human milk fat can bind and neutralize shiga-like toxin, and carry SIg. A throughout intestine – Balance of fatty acids might affect dvpt of allergic disease

What does Pasteurization do to Milk Components? JHL 17(2) May 2001 p. 154

Donor Milk is Nutritionally Inferior, leading to slower growth and more abnormalities in bone metabolism • Stein, H. et al J pediatr Gastroenterol Nutr. 1986; 5: 242 -247 • Tyson, JE, et al J Pediatr. 1983; 103: 95 -104 • Gross SJ NEJM 1983; 308: 237 -241 • Raiha NCR et al Pediatrics 1976; 57: 659 -674

Variations in Protein and Energy Contents of Human Milk Schanler, ABM, Oct 99, Adapted from Polberger 1996 Protein g/dl Mean (range) Energy (kcal/dl) Mean (range) 1. 7 (1. 1 -2. 7) 65 (52 -79) Preterm Banked 1. 5 (1. 0 -2. 2) Milk 65 (59 -74) Term Banked Milk 63 (48 -77) MOM 1. 3 (0. 9 -1. 7)

Low Docosahexanoic and AA levels in Donor Milk Valentine J Peds 2010; 157: 906 -910 • 39 healthy qualified donors • Average 22 cal/oz, average protein 0. 9 mg/dl • No diff in pre/post pasteurization total FA levels, very small effect on free AA levels. – Preterm milk has higher AA levels • DHA levels and AA levels in donor milk lower than other BM studies, and lower than in-utero fetal levels. – Related to diet of donors – Later lactational stages have less DHA

Mothers Milk Fresh vs Frozen vs Pasteurized JPGN 2010; 51: 347– 352 • Fresh BM is more inhibitory of bacterial growth than frozen milk, which is more inhibitory than pasteurized • Several host defense proteins are adversely affected by freezing, and more so by Holder pasteurization

Pooled Pasteurized Breast Milk and Untreated Own Mother’s Milk in the Feeding of VLBW Babies: a RCT Stein et al JPGN 1986 5: 242 MOM Pooled Term DM P Value Days to regain birthweight 11. 5 17. 2 <0. 0001 Days from regained Bwt to 1800 gm 32 44 <0. 0001 Growth (gm/day) 16 12 <0. 0001 Increase in HC Cm/wk 0. 77 0. 74 0. 8 Increase in length Cm/wk 0. 77 0. 5

The Good News

How Safe is Donor Human Milk • Holder pasteurization eliminates – viral contaminants • HIV Orloff, SL, et al J Hum Lact 1993; 9: 13 -17 • HTLV-1 Yamato, K et al Jpn J Cancer Res 1986; 77: 13 -15 • CMV Friis H, et al Br Med J 1982; 285: 77: 13 -15 – Bacterial contaminants » Wills, et al Early Hum Dev 1982: 7: 71 -80 • There have been no reported illnesses transmitted from pasteurized donor milk to recipients.

Is it Reasonable to Use Donor Human Milk for Premies? • DM vs PTF for preventing NEC • Mc. Guire, W. Arch Dis Child Fetal Neonat Ed. 2003; 88: F 11 -F 14 – Systematic review and meta-analysis of 4 small, older studies. Each showed no signif difference, but meta-analysis found that DM: » 4 times less likely to have confirmed NEC RR 0. 25, CI 0. 06 -0. 98

Donor Human Milk vs Preterm Formula for Premies Schanler, et al Pediatrics Aug 2005 116(2) • Group MM had fewer episodes of LOS and/or NEC and total infections, and a shorter hosp stay as compared to DM and PF. • No differences in DM and PF in LOS and/or NEC, total infections, hosp length of stay, or deaths. • DM group needed more nutritional supplementation and had a slower rate of weight gain.

Donor Human Milk vs Preterm Formula for Premies Schanler, et al Pediatrics Aug 2005 116(2)

Donor Human Milk vs Preterm Formula for Premies Schanler, et al Pediatrics Aug 2005 116(2)

Donor Milk vs PTF for Prematures Schanler et al Pediatrics 2005; 116: 40 -406 • DM group and PTF each received 50% MM, and 17 (21%) of DM group switched to PTF due to poor weight gain • Few NEC cases in the study – 6% for MM and DM, 11% for PTF; too few to measure diff • • Less CLD with MM and DM Less ROP with MM Long term benefits not investigated MM best- less NEC, ROP, LOS, length of stay

Protein Intake of Preterm Infants J Perinatology (2009) 29 p. 489 -92 • Adjustable fortification regimen vs standard fortification regimen – ADJ- increase in fortification according to BUN – STD- same amount of fortifier-5 grams/100 ml • Actual protein and fat intakes were less than assumed for each group – ADJ group was given more protein than the STD group. • Summary- levels of protein and fat cannot be assumed in MM or DHM. • Growth outcomes were not reported in this study

Formula vs Banked Donor Milk for Feeding VLBW and Premies Cochrane 2008 • Higher short term growth with PTF but no evidence of long term outcomes for growth rate or neuro development • Only 1/8 studies used fortified donor milk • Higher NEC rates in formula fed infants, RR=2. 5 x. • Recommendation to perform studies using fortified donor human milk.

Banked Preterm vs Banked term DHM for VLBW Infants (Cochrane 2010) • No evidence available

Oligosaccharides Bertino Early child Dev 2009 • Not affected by Holder Pasteurization • Prebiotic, immunomodulatory, antimicrobial effects • Resistant to digestion, reach the colon – Help push growth of bifidus flora in colon – Bind pathogens to prevent infection – Reduce gut inflammation

Summarize • Breastmilk is best for VLBW infants • Nutritional values in breastmilk change from preterm to term milk, and over time during lactation. • Pasteurization affects nutritional properties of BM, but many protective properties are spared. • Most banked donor human milk is term milk. • Slower growth on pooled DHM vs MM – Biologically makes sense that preterm DHM is more beneficial than mature or pooled DHM. – Preterm DHM requires fortification, adjustable may be better than standard method.

Donor Recruitment Ø Discharge packets Ø Mother’s groups Ø LLL meetings Ø Pediatrician’s Office Ø Lactation Consultants Ø Mother-Baby stores Ø Word of mouth Ø Radio, TV, Billboards, buses Ø Info card for contacting MMBWGL milk depot

Characteristics of Human Milk Donors Osbaldiston, Mingle JHL 2007 23: 350 • Study of 87 donors, vs 19 nondonor controls • Most were married, young, financially secure, healthy • Few barriers/problems with donating to Austin bank. • 97% would donate again • Motivated by altruistic and benevolent reasons – To help others – Had too much milk, wanted to donate it – Would ‘hope that someone would do the same if I were in need’

Screening Donors • • • Donors are women with extra breastmilk. Telephone Interview Written Documentation Lab Work Milk Culture

Screening of Donors • Telephone Interview Good Health, no chronic illnesses or infections, neg. blood tests No regular medication or herbal usage except for very few exceptions Willing to donate at least 200 ml of milk that has been frozen <6 mo Medically cleared by mom’s and baby’s physicians No risk of HIV, use of unsterilized needles, or partner at risk Nonsmoker, no illicit drugs, no regular Et. OH or heavy caffeine 24 oz max for coffee, tea, cola 12 hour waiting period after drinking alcohol No history of a blood tx or organ transplant within 6 mo Born or travel to various areas in Africa If in UK>3 mo, or in Europe >5 yrs 1980 -1996

Screening of Donors Written Documentation • Complete health history and review of prenatal lab results • Medical Release from mother and baby’s primary care providers

Blood Screening of Donors • • HIV 1 and 2 HTLV 1 and 2 HBs. Ag Hep C antibodies VDRL or RPR PPD depending on population Donors are rescreened every 6 months at some banks.

Bacteriologic Screening of Milk Before Pasteurization • Donated milk is thawed and cultured to test for contamination

Milk Processing Upon Arrival to Ohio • Milk is thawed and pooled together, about 3 -5 donors in one flask to balance components • 3 ounce plastic bottles are filled with the raw milk • Holder method of pasteurization- bottles placed in a shaking water bath heated to 62. 5 Deg C for 30 minutes • Rapid cooling via cold water in 10 minutes, and then frozen to – 20 deg C. • Milk is cultured before and after the pasteurization process before shipping.

Types of Milk • • • Mature Preterm Early mature Early preterm Non-dairy

Receiving Pasteurized Donor Milk • Banks require a physician’s prescription with diagnosis – May phone, fax or email requests for milk • Milk is shipped frozen overnight. • Cost of milk is $3 -4. 00 per ounce as a processing fee, plus a shipping fee.

Handling of Donor Milk • Facility keeps HDM frozen at -4°F • Estimated milk requirements for 12 hour is removed from freezer • Date and time of removal is written on bottle • HDM is slowly thawed over 20 minutes in warm water bath – Thaw until all milk is liquid • Gently swirl to homogenize separated layers

Using DHM • Single bottle of DHM is usable by several infants • Opened bottle of human donor milk is kept refrigerated for up to 48 hours • Unopened bottle of Human Donor Milk is safe refrigerated for 72 hours • Record on Recipient Log for whom each bottle of DHM is used • Recipient Log is maintained by hospital and/or faxed to milk bank • Pasteurized DHM from the bank has expiration dates.

Mother’s Milk Assoc of Wisconsin • Long range plan of establishing a human milk bank in Wisconsin • 501 c 3 since 2005 • 6 drop off sites established, 5 in WI, 1 in Minnesota • Blood tests are drawn by volunteers for MMAW • Volunteers gather milk from donors and ship the milk via Angel Flight to the Mothers’ Milk Bank of Ohio. • Milk is distributed by Ohio to hospitals and outpatients with physician prescription. • MMAW is teaming with IL to create MMBWGL

MMAW Depot Responsibilities • Depot is ideally in a medical facility • Maintain the freezer – Keep clean, temp log, safe from tampering • Keep a log of donor milk in freezer – All milk should be labeled • Stay in contact with MMAW to coordinate flights to Ohio • Pack up milk in coolers within 1 -2 hours of the flight • Meet pilot at the airport with donated milk • Thank the pilot!!

Common Diagnoses for the Use of Donor Human Milk in 2002 JHL 20(1) 2004 p. 77 • Prematurity • Allergies – Formula intolerance • • • Failure to thrive Adopted babies Congenital anomalies Inborn errors of metab Maternal problems Adult treatment • Cancer • Immune deficiency • GI diseases • • Chronic diarrhea Hirschsprungs NEC Short gut syndrome • Post-op therapy • Cardiac repair • Cleft palate repair • Intestinal repair, transplant

FDA and HMBANA • FDA recommends against feeding your baby breast milk acquired directly from individuals or through the Internet. • FDA recommends that if, after consultation with a healthcare provider, you decide to feed a baby with human milk from a source other than the baby’s mother, you should only use milk from a source that has screened its milk donors and taken other precautions to ensure the safety of its milk. – There are human milk banks that take voluntary steps to screen milk donors, and safely collect, process, handle, test, and store the milk. In a few states, there are required safety standards for such milk banks. FDA has not been involved in establishing these voluntary guidelines or state standards.

Conclusions • Breastmilk is the ideal food for all infants, including VLBW. • DHM is a second option to MM but preterm infants should receive preterm DHM. • Human Milk banking in the USA is safe, with no negative incidents reported. • WI and IL are on the verge of developing a nonprofit human milk bank. – www. milkbankwgl. org, www. mothersmilkwi. org