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 1st Choice for VLBW
Infant (Cochrane 2010)
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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 1st 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
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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
– SIgA (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 SIgA
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
SIgA 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 22cal/oz, average protein 0.9mg/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
1800gm
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
0.77
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• McGuire, W. Arch Dis Child Fetal Neonat Ed. 2003;
88:F11-F14
– 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
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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-5grams/100ml
• 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=2.5x.
• 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
 Discharge packets
 Mother’s groups
 LLL meetings
 Pediatrician’s Office
 Lactation Consultants
 Mother-Baby stores
 Word of mouth
 Radio, TV, Billboards, buses
 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
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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 <6mo
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 EtOH 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>3mo, or in Europe >5yrs 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
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HIV 1 and 2
HTLV 1 and 2
HBsAg
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
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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
• 501c3 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
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Failure to thrive
Adopted babies
Congenital anomalies
Inborn errors of metab
Maternal problems
Adult treatment
• Cancer
• Immune deficiency
• GI diseases
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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