Human Milk Banking Benefits

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Title: Human Milk Banking Benefits

1
Human Milk Banking - Benefits Limitations

Susan Landers MD FAAP FABM
Mothers Milk Bank at Austin
Pediatrix Medical Group
Austin TX

2
Objectives

Review benefits of human milk feedings for
preterm infants.
Review potential economic benefits of
breastfeeding.
Review history of donor milk banking clinical
uses for donor human milk associated costs.
Describe HMBANA milk banking guidelines
procedures.
Identify infection risks associated with human
milk feedings.
Discuss current controversies in human milk
banking.

3
Benefits of human milk feedings

High quality human milk protein
Enhanced fat absorption
Improved absorption of lactose minerals
Enhanced gastric emptying
Unique species-specific ingredients promoting
brain growth cognition
Unique factors enhancing intellectual visual
development

4
Short term benefits of human milk feedings for
preterm infants

Shorter LOS less sepsis less necrotizing
enterocolitis (NEC) less TPN cholestasis.
Both exclusive and partial human milk feedings
(compared to formula) protect against NEC.
Improved host defenses from functional WBCs
IgA nutrient enzyme activity lactoferrin
lysozyme oligosaccharides.
Bioactive factors active peptides
glycoproteinsare growth-promoting for specific
cell types.
Trophic factors promote GI maturation and growth
hormonal responses and probiotic gut
colonization with non-pathogenic bacterial flora.

5
Effect of human milk feeding on morbidity
hospital stay
Schanler et al. Pediatrics 19991031150-57. B.
Wt. 1000 g GA lt30 wks p lt 0.01 plt0.07
plt0.05
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7
Longer term benefits

Neuro-developmental outcome IQ measurably
improved in preterm infants fed human milk.
Human milk-fed LBW infants compared to
formula-fed babies
improved cognitive function (5 points)
higher IQ scores (8 points) measured at 3 and 8
yr. age (adjusted for maternal education and SES)
Cognitive developmental benefits of breastfeeding
increase with duration of breastfeeding.

Lucas Lancet 1992339261
8
Outcomes by quintiles of breastmilk intake in
ELBW infants
Vohr et al. Pediatrics 2006118e115. NICHD
n775 EBM n 260 no EBM 800g 27 wks. Bayley
II MDImental dev index PDI psychomotor dev
index BRSbehavioral rating scale
9
Long term health benefits from breastfeeding

Lower incidence of otitis media URI infectious
diarrhea UTI bacteremia meningitis
Reduced rates of
Sudden infant death syndrome (SIDS)
Ulcerative colitis and Crohns disease
Insulin-dependent (type I) diabetes type II
diabetes
Allergic diseases and asthma
Lymphoma leukemia and Hodgkins disease
Reduction in overweight and obesity

10
Maternal benefits

Delayed return of fertility increased child
spacing
Less lifetime blood loss (lactation amenorrhea)
Reduced risk of ovarian cancer
Lower rate of pre-menopausal breast cancer
4 reduction for every year breastfeeding
Reduced rate of spinal and hip fractures
Lower rate of metabolic syndrome (obesity type
II diabetes hypertension)
Improved bonding and sense of self-competency

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Potential economic benefits - feeding EBM saves
money

NEC increases risk for death infection CVL
TPN LOS.
Hospital charges for NEC care in excess of
controls
Surgical NEC costs 186200
Medical NEC costs 73700
Among 150 VLBW infants/yr in NICU if 15 are fed
preterm formula (not EBM) then
315 extra hosp days
2.3 cases NEC
6.3 episodes LOS
210 extra days TPN
Estimated cost/ infant of being fed PT formula
9700.

13
Other economic benefits

Business gets 3 return per 1 invested for
breastfeeding support.
Lower healthcare costs for business
400 savings in first year for BF baby
50 lower prescription costs.
Less maternal absenteeism improved workplace
satisfaction higher morale greater
productivity.
Greater employee retention company loyalty.
Enhanced company marketing as family-friendly
workplace.

14
History of human milk banking

Wet nursing
Artificial feeding formulas
Modern milk banking
Commercial refrigeration since 1850s
First milk bank 1909 in Vienna
Boston Wet Nurses Directory 1910-19
Others in Germany by 1915
Lactarium in Paris 1947
AAP guidelines in 1943 (J Pediatrics
194323112-128)
By early 1980s 23 banks in Canada and 30 in US
Human Milk Banking Association of North America
(HMBANA) est. 1985

15
Modern human milk banking

HMBANA
Organizations in other countries
UKAMB other European countries
South America Brazil Venezuela
South Africa
Other countries India Japan China
National Milk Bank est. 2005
Prolacta Bioscience est. 2005
International Human Milk Banking Association
In formation

16
Modern donor human milk banks
25
15
4
16
1
18
8
11
8
1
185
1
2
17
Accessibility

HMBANA http//www.hmbana.org
Mothers Milk Bank at Austin http//www.mmbaustin.
org
National Milk Bank http//www.nationalmilkbank.or
g
Prolacta Bioscience http//www.prolacta.com
UKAMB http//www.ukamb.org
South Africa http//www.ithembalethu.org

18
Human milk banking in Brazil

Breastfeeding duration from 5.5 mos. (1989) to
10 mos. (1999).
In April 2001 Brazil had 182 Baby-Friendly
Hospitals.
Banked human milk saved Brazils Ministry of
Health 540 million/ year.
Network of 150 milk banks collects donated milk
gt 218000 liters/ year (1999-2000) providing milk
for 300000 pre-term infants.
6000 mail carriers trained in the Breastfeeding
Friendly Postman Program.
Involving firefighters mail carriers in
breastfeeding support roles allows the government
to emphasize importance of breastfeeding to
entire country.
Source http//www.infactcanada.ca

19
Internet access to human milk donation

Milkshare.birthingforlife.com
created to educate women about alternatives to
receiving banked milk. an educational resource
and connection point designed to give mothers who
are unable to produce. milk some tools to
explore private milk donation. MilkShare does
not support the selling of breastmilk.
Feedmybaby.com
Craigs list (http//chicago.craigslist.org)
Donateyourmilk.com
http//familybirthcenters.com/fortmyers/breastmilk
bank.html

20
CONTROVERSIES

Cost
Safety issues
Donor screening
Quality control
Heat treatment methods
Holder pasteurization method
HTST flash method
Federal regulation
Regulation by state laws
Nutritional labeling of content
Clinical efficacy of benefit
Availability
Not-for-profit entities
For-profit corporations
Ad hoc internet sales
Ethical issues

21
Land of milk money Breast-milk enterprise
raises concerns among those who view collection
and distribution as a philanthropic endeavor By
Deborah EnsorSTAFF WRITER February 12 2006
LAURA EMBRY / Union-Tribune Machinery to process
donated breast milk is tested and observed by
(from left) Raymond Ortega Jose Maldonado and
Armando Montoya at the Prolacta Bioscience
facility in Monrovia. The company intends to sell
its product to hospitals to feed low birth weight
and critically ill babies.
22
Got breast milk Buyers are willing to payBut
booming trade raises safety ethical
questions By Marsha Austin - The Denver
Post3/26/2006 You wont find it on any
commodities exchange but there is a booming
trade in mothers breast milk.The nations
largest nonprofit milk banks distributed 745329
ounces last year double the amount in 2000 at
a cost of 2.6 million.Prolacta Bioscience a
for-profit company in August started marketing a
breast-milk concentrate for 48 an ounce.And
some mothers are selling their own milk on the
Internet for 1 to 2.50 an ounce more than a
third less than milk from the big banks.Since
January one popular Web site has listed more
than 100 human-milk advertisements.This is all
going on with little regulation raising ethical
and safety questions.
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24
Clinical uses of donor human milk

Nutritional support
Prematurity
Failure to thrive
Malabsorption syndromes
Feeding intolerance
Preventative
NEC
Crohns disease
Colitis

Medical and therapeutic
Short gut syndrome (NEC)
Infectious diseases (AGE sepsis pneumonia)
Post-surgical gut healing (omphalocele
gastroschisis bowel obstruction)
Immunological diseases (allergies IgA def)
Renal failure
Inborn errors of metabolism

JHL 200420(1)75-7.
25
Other clinical uses for donor human milk

Allergies
Formula intolerance
Adopted babies
Congenital anomalies
Maternal problems
Breast cancer
Adult treatment
Cancer
Immune deficiency
AIDS

Other GI diseases
Chronic diarrhea
Botulism
Hirschsprungs disease
Post-op therapy
Cardiac repair
Cleft palate repair
Transplantation

JHL 200420(1)75-7.
26
Donor Human Milk

60-70 of banked human milk goes to out-patients
older infants children and occasionally adults.
HMBANA recommends highest priority for
Ill premature infants
Well premature infants
Infants lt 12 months with qualifying medical
problems
Infants over 12 months with illnesses thought to
be responsive to donor human milk.

27
Studies of clinical efficacy of donor human milk

Donor breast milk versus infant formula for
preterm infants systematic review
meta-analysis. Boyd CA Quigley MA Brocklehurst
P. Arch Dis Child Fetal Neonatal Ed. 200792
F169.
Donor human milk versus formula for preventing
NEC McGuire W Anthony M. Arch Dis Child Fetal
Neo Ed. 200388F11.
Donor human milk for preterm infants Wight N.
J. Perinatol 2001211.
Breast milk and neonatal NEC Lucas Cole.
Lancet 19903361519.

28
Growth parameters infection related events
among ELBW infants
RCT donor human milk v. preterm formula.
Schanler. Peds 2005 116(2) 400-406.
29
Better growth in premature infants managed with
adjustable fortification of human milk
Arslanoglu S Moro GE Ziegler EE. Adjustable
fortification of human milk fed to preterm
infants. J Perinatol 200626614. Italy n32
60 MM 40 donor BM.
30
Late onset sepsis in Norwegian cohort of ELBW
infants. Ronnestad Pediatrics 2005115(3)269.
1999-2000 births n405
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32
Regulation and oversight

Human Milk Banking Association of North America
(HMBANA)
Centers for Disease Control Prevention (CDC)
Food Drug Administration (FDA)
State Departments of Health state laws
TX guidelines related to procurement
processing and distribution of human milk
NY CA laws requiring banks to be licensed
with state before distributing milk

33
HMBANA Donor Milk Banks 2008
San Jose CA Denver CO Indianapolis IN Iowa
City IA Kalamazoo MI Raleigh NC Columbus
OH Austin TX Ft. Worth TX Vancouver
BC Newtonville MA
34
Cities with hospitals servedby HMBANA in 2007
In-patients only
35
HMBANA publications
2007 Guidelines for the Establishment and
Operation of a Donor Human Milk Bank
40/copy 2006 Best Practice for Expressing
Storing and Handling of Mothers Own Milk in
Hospital and at Home 50/copy 2006 Starting a
Donor Human Milk Bank A Practical Guide
25/copy www.hmbana.org
36
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38
Mothers Milk Bank at Austin
39
Mothers Milk Bank at Austin Income in 1000
40
Mothers Milk Bank at Austin Expenses in 1000
Excludes capital expenses
41
Human milk banking - donor selection

Identification education of potential donors
good health
no medications or herbal supplements
nursing infant lt 1 year old
Review of donors medical health history
Exclusion criteria
Donor screening methods
Verbal written laboratory
Serological testing
HIV HTLV III HBV HCV syphilis /- TB
Costs 150 300/ donor

42
Donor exclusion criteria

Positive test for HIV HTLV HBV HCV syphilis
She or partner at risk behaviors for HIV
Use of illegal drugs
Smokes or uses tobacco products
Drinks more than two alcoholic drinks per day
Organ or tissue transplant or blood
transfusion in last 12 months
Tattoo or body piercing in last 12 months
Traveled to UK for gt 3 months or Europe gt 5
months from 1980-1996
Same criteria as American Assoc. Blood Banks
(AABB www.aabb.org)

43
Donor selection human milk collection

Medical releases donors ObGyn infants Pedi
Minimum milk volume 100 ounces
Donor education proper collection storage
transportation methods
Donor instructions
to express milk using specific protocols
proper hygiene handling labeling
Storage at -20 C
polyethylene containers
at home or in milk depots
Transportation on dry ice

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45
Donor milk handling

Frozen donor human milk defrosted pooled mixed
Lab workers use universal precautions
Freezing at -20 C destroys HTLV and CMV
Milk pasteurized at 62.5 C for 30 minutes
Holder method commercial pasteurizer
Destroys bacteria viruses yet retains many
immunological nutritional properties
56 C destroys HIV HTLV CMV
62.5 C destroys TB

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48
Pasteurization of Human Milk
49
Donor milk processing

Pre-pasteurization bacteriological screening
screens donor technique
Heat processing
Post-pasteurization bacteriological testing
screens heat treatment procedure
no positive cultures are acceptable
93-99 are sterile
Chilling storage
No documented case of disease transmission
through use of pasteurized donor human milk.

50
Frozen Pasteurized Human Milk Stored at - 20 C
51
Pre-pasteurization bacterial contamination MMBA
2002
52
Possible transmission of viruses through Human
Milk (HM)
Detected in HM Mother to child Disease
transmission CMV
HIV-1
AIDS HTLV-1
T cell lymphoma HBV
_ _ HCV _ _ Rubella
_ O West Nile
O Adapted from Robert F. Pass MD
53
Factors influencing safety of donor human milk

Donor screening honesty
Medication /or herbal exposure
Potential infectious agents
Milk changes from storage preservation
Milk changes from heat treatment methods
Quality control of milk banking techniques

54
Donor milk distribution

Dispensed by prescription only
Cost varies 3.00 4.50 per ounce
Packaging labeling
Preterm donor milk
Donor mother delivered lt 36 weeks
Designated preterm for 4 weeks
Term donor milk
Infant born at greater than 36 weeks

55
Milk banks IRS income tax status

Not-for-profit (501c3)
Hospital-based or
Independent community- based
Business plans
Other funding - grants
Financials reports on-line
via IRS
HMBANA affiliation
Processing fee charged per oz donor milk
Both in out-patients served

For-profit
Different business model
Private venture capital (4 million)
National Milk Bank affiliation
Donor milk other products sold
Only in-patients served

56
Milk banks IRS Income tax status

Not-for-profit
Oversight
Medical advisory board
Board of Directors
Regulated by state laws
HMBANA guidelines
FDA CDC input

For-profit
Oversight
Medical advisory board
Board of Directors
FDA regulations
For food
For pharmaceuticals
Advertising
Marketing
Compensation to donors (breast pumps)
Money to hospitals

57
IRS Income tax status

Not-for-profit
Donor screening
Quality control
Pasteurization method
Holder
Cost of donor milk
3 - 4.50/oz

For-profit
Donor screening
Quality control
Pasteurization method
HTST
Cost of donor milk
30/oz (or 10/10ml)

www.mmbaustin.org www.prolacta.com
58
Prolacta donor screening quality control

Written verbal heath risk questionnaires
Physician statements RE mothers babys health
Donor serological testing (HIV HTLV HBV HCV
RPR)
Donor milk drug testing
Donor tracking system
DNA fingerprinting (to ensure donor milk belongs
to screened donor)
Cold chain delivery system data logging
technology
PCR testing for infectious diseases on milk pools
both pre post-pasteurization
Microbiological testing both pre
post-pasteurization

59
Heat treatment methods used with human milk

Holder Pasteurization
62.5 ºC for 30 minutes
HTST (high temperature-short time)
72 ºC for 16 seconds

60
Effective RF HIV HCV HBV
BVDV HCV (bovine viral diarrhea) PRV HBV
(pseudo-rabies virus) PPV HPV (porcine
parvovirus) RF reduction factors
Terpstra Rechtman et al. Viral reduction with
HTST. BF Med 2007227-33
61
Terpstra Rechtman et al. Antimicrobial and
antiviral effect of HTST pasteurization applied
to human milk. Breastfeeding Med 2007227-33
62
Milk treatment methods - effect on CMV milk
components
Hamprecht et al. Pediatr Res 200456(4) 529-535.
63
Components of human milk altered by freezing
pasteurization
J Human Lact 200117(2) 154.
64
Nutritional labeling of donor milk
65
Milkoscan FT-120 (Foss Electric) calibrated to
human milk using standard USDA manual assays for
carbohydrate protein and fat.
(Carbohydrate-lactose AOAC 984.15 Protein
N-Kjeldahl AOAC 991.20 Fat-Ether extraction
AOAC 989.05)
66
Rivera Updegrove. Mothers Milk Bank at Austin.
Variation of content of donor human milk.
Presented AAP NCE 2004.
67
Rivera Updegrove. Mothers Milk Bank at Austin.
Variation of content of donor human milk.
Presented AAP NCE 2004.
68
Nutritional content of human milk
Rev Panam Salud Publica 200416(3)199.
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