Donor Human Milk
1
Barbara L. Carr, MD, FAAP
Medical Director Heart of America Mothers’ Milk Bank
Medical Director Saint Luke’s Hospital of Kansas City NICU
2
Human Milk Banking Association of North
America
 Established
in 1985
 Mission





To set standards for and facilitate the establishment and
operation of milk banks in North America
Be a forum for information sharing
Educate the medical community
Encourage research
Act as a liaison between member banks and government
agencies
3
HMBANA
 Consists
of
14 operational banks
 4 developing banks
 1 mentoring bank

 Dispensed:
2000
 2005
 2010
 2011

~410,000 oz
~745,000 oz
~1.7 million oz
~2.2 million oz
4
5
Donor Human Milk-who donates?
 Donated
milk from women with excess milk
Often later in lactation
 Recognize the importance of human milk

 May

be preterm or term milk
Sometimes part of bereavement
6
Donor Screening Process
 Initial
contact with milk bank may be by phone or
email
 Screeners discuss basic information with potential
donors and determine preliminary eligibility
Smoker?
 Medications?
 Drug Use?

 Health
screen and physician letters are sent
 Commit to donating at least 100-150oz*.
7
Donor Screening Process
 Donor
Screens and physician approvals are triple
checked
 Blood work obtained at the time milk is sent in

HIV (0,1,2), HTLV I/II, Syphilis, Hepatitis B/C
 Milk
quarantined until eligibility confirmed.
8
Milk processing
 Initial
bacterial culture is obtained
 Milk is then pooled
 Holder method of pasteurization
 Repeat bacterial culture obtained and milk is again
held until results available.
 Milk frozen until dispensed.
 Some
milk may be deemed suitable only for
research
9
Who receives it
 Dispensed
by prescription
 Infants, usually premature, in Neonatal Intensive
Care Units
 Limited outpatient use
 Some compassionate use pending availability
10
Nutritional content
 Protein


1.16% ±0.25% (range 0.7% to 2.1%)
Typical mature milk 1.0-1.2%
 Fat*
3.22% ± 1% (range 0.71% to 7.06%)
 Typical mature milk 3.9-4.2%

 Carbohydrate
7.8% ± 0.88% (range 4.86% to12.67%)
 Typical mature milk 7.2-7.3%

 Average

calories per oz = 19.2 ±3.1 kcal/oz
25% of samples were <17 kcal/oz
J Am Diet Assoc. 2009;109:137-140
11
Nutritional Content
 Preterm
infants need ~120kcal/kg/d intake and 3.54g protein per day
 Notably tested term milk, not 24h samples
 Likely reflects realistic picture of nutrient content
 Preterm milk not tested
J Am Diet Assoc. 2009;109:137-140
12
DHM-Nutrition
 Growth
is decreased in premature infants when
using unmodified term DHM.
 Studies have confirmed this-all but one have
compared unfortified term DHM.
 Need studies to evaluate fortified DHM (incl preterm)
vs. maternal milk or formula as the primary outcome
(typical NICU practice).
 Can target pool DHM for higher protein, fat, low dairy
etc.
13
Human milk –Not just Nutrition!
 For
the preterm infant, human milk is considered by
many to be lacking nutritionally (not just DHM). (?)

Enter preterm formula
 Need
to remember the importance of gut related
immunity and the developmental/complementary role
that human milk plays.
14
Benefits of Human Milk
 Anti-infective
sIgA
 Glycoproteins (oligosaccharides)
 Lactoferrin
 lysozyme

 Anti-inflammatory
Cytokines
 Platelet activating factor acetylhydrolase
 Transforming growth factor Beta

15
Immunologic content
16
Immune System Benefits of Human Milk

Barrier/Receptor Site Binding
 sIgA-binds sIgA receptors lining mucosa and
competing for adherence sites/invasion by pathogens Highly targeted to the maternal environment
 Preemies have the most significant uptake
 Glycoproteins (mucin, lactadherin, and
oligosaccharides) provide alternate receptor site
binding
 Lactoferrin competes for iron binding sites and
damages membranes of pathogens
The Evidence for Use of Human Milk in Very Low Birthweight
Preterm Infants Neoreviews 2007;8:e459-e466
The Mucosal Immune System and Its Integration with the
Mammary Glands. JPeds;156(2)Suppl1; s8-s16
17
Immune system benefits of Human Milk
 Oligosaccharides

encourage gI colonization of commensal bacteria
(bifidobacteria)-act to tighten mucosal barriers and
compete for adherence sites
 Bacterial

–the premier prebiotic
Cell wall lysis
Lysozyme and byproducts of lipid digestion assist in cell
wall lysis
The Evidence for Use of Human Milk in Very Low
Birthweight Preterm Infants Neoreviews
2007;8:e459-e466
Newburg, DS et al Annu Rev Nutri 2005; 25:3758
18
Anti-inflammatory effects
 Binding

of toll like receptors
CD14
Decreased IL-8 production via lack of activation of
NF-kappa-B
 Epidermal growth factors, prostaglandins, antiinflammatory cytokines (IL-10)
 Platelet activating factor acetylhydrolase (PAF-AH)
 Minimal concentrations in gut until 6weeks
 Is present in human milk

The Evidence for Use of Human Milk in Very Low Birthweight
Preterm Infants Neoreviews 2007;8:e459-e466
19
Anti-Inflammatory effects
 High
concentrations of LCPUFA
 Antioxidants (vitamin E, inositol, beta carotene)
 Additional research particularly focusing on
oligosaccharides is ongoing.
20
Immunologic content
21
Use of DHM in premature infants
 Reach
full enteral feedings sooner
 Decreased TPN days so late onset infection and other
associated side effects are decreased.
 NEC reduction
Schanler et al Seminars in Perinatology 1994 (18)
Quigley et al Cochrane Review 2007
22
Donor human milk, prevention of necrotizing enterocolitis
McGuire & Anthony, Arch Dis Child 88:F11 (2003)
23
Donor milk and NEC in premature
infants
DM

(n=78)
 Sepsis
(%)
29
 NEC (%)
6
 BPD (%)
15
 Wt gain (g/kg/d) 17.1
p
PF
(n=88)
30
11
0.048
0.001
p MM
(n=70)
0.022 23
6
28 0.044 13
20.1
18.8
Schanler et al., Pediatrics 2005;116:400-406
 Note: All infants initially received their mother’s milk

24
NEC reduction
 Increasing
evidence of a dose dependent
relationship (Schanler, Meinzen-Derr).
 NICHD study
1433 infants
 1272 met inclusion criteria
 13% reduction for each 100ml/kg incremental increase in
intake)

Meinzen-Derr et al J Perinatol 2009;29:57-62
25
Adjusted survival curves for NEC or death by proportion of HM
to total intake over the first 14d of life (Meinzen-Derr et al)
26
Neurodevelopmental Outcomes
 Lucas
et al showed a sig higher IQ (8.3 point
advantage)in HM fed group; dose response with 9.0
point advantage for those fed exclusive HM
 Furman et al –no effect on cognitive development
and overall neurodevelopment
27
Neurodevelomental Outcomes
 NICHD
Glutamine Trial-dose response relationship
between amount of HM and neurodevelopmental
outcomes at 18mos
 For each 10 mL/kg/day incr in HM feeding
Psychomotor Development Index incr 0.63 points
 Mental Development Index incr 0.53 points

 No
data for DHM
28
Potential negatives of DHM
 Decreased
growth
Shown in multiple studies to have slower growth rates
versus mother’s own milk or formula
 No studies comparing current standard of use
 Fortification allows normal growth rates.

 Mother

won’t pump?
Most units see an increase in mother’s own milk
production (initiation and duration)
 Infection

No evidence of transmitted infection with pasteurized milk
from milk banks.
29
Potential negatives of DHM
 Expense
≥$4.50 per ounce
 Cost not typically covered by insurance
 Compare to NEC ($150,000/2weeks longer stay)

 Outcomes

No long term outcome studies available-length of stay,
neurodevelopment, bone mineralization/growth (existing
data supports use of maternal milk)
30
Use of Donor Human Milk
at Saint Luke’s Hospital
 Began
as part of two quality improvement projectspart of Pediatrix Medical Group’s 100,000 Babies
Campaign.
 Increase the use of human milk and lower the
incidence of NEC.
 Concept introduced by multidisciplinary team to the
NICU
31
Use of Donor Human Milk
at Saint Luke’s Hospital
 Support
garnered from medical and nursing staff
Dealt with concerns re: safety, nutrition, “yuck” factor,
“need more science”.
 RN champions on all shifts

 Proposal
supported by hospital administration
 Protocols developed for use in the NICU
32
Use of Donor Human Milk
at Saint Luke’s Hospital
 Mothers
receive a pamphlet during the prenatal
consultation
 Additional fact sheet in the “Jungle Book”
 MD or NNP obtains consent after risk/benefit
discussion
 Emphasis placed on the importance of mothers’ own
milk and use of DHM as a bridge/supplement.
33
Use of Donor Human Milk
at Saint Luke’s Hospital
 For
infants <1500g
 DHM until 2kg
 For infants 1500-2000g
 DHM for two weeks
 For infants >2000g (and mother plans to breastfeed)
 DHM for one week
 For infants as medically indicated (ex NEC recovery,
gastroschisis, etc)
34
Use of Donor Human Milk
at Saint Luke’s Hospital
 Preterm
donor milk
 for infants <1250g (due to limited supply).
 High calorie term donor milk
 for infants >1250g.
 term donor milk
 for infants >2kg
 Donor colostrum (when available)
 for initial feedings for infants <1250g
35
Use of Donor Human Milk
at Saint Luke’s Hospital
 First
feeding to be given as mother’s own
milk, followed by donor milk as needed to
supplement maternal supply.
 Do not dilute the initial maternal milk feeding
with either donor milk or formula to achieve a
specific volume
36
Use of Donor Human Milk
at Saint Luke’s Hospital
 Infants
are transitioned off of DHM when they have
met the predefined criteria or are approaching
discharge and taking ~50% oral feedings.
 “Hypoallergenic” formula may be used after DHM
protocol in lieu of standard formula for mothers with
insufficient but increasing supply.
37
Barriers to using DHM
 Availability
–
Lack of donors
 Competition-commercial use, informal sharing (internet
sales)

 Medical
community
 Formula
 Perception
of community
38
Competition for Milk
In 2011, the 11 dispensing non profit milk banks
distributed ~2.2 million ounces of milk to hospitals.
 The need continues to increase.
 To meet the needs of all VLBW infants in the US,
we would need as estimated 9 million ounces
annually.

39
The Cost of Milk
Pasteurized donor milk costs ~$4.50/ounce from
HMBANA banks
 Milk that is higher in protein or kcals may cost up to
$6-7 per ounce
 Milk sold online from $1-4 per ounce
 Prolacta Bioscience products:

Up to $187 per ounce for H2MF
 $30 per ounce for “Neo 20”
 $45 per ounce for “Premie Lact”

40
Ounces of Milk Produced
41
HMBANA’s stance
FDA
v
On December 6, 2010, the U.S. Food and Drug
Administration's Office of Pediatric Therapeutics convened a
meeting of national experts, including directors of two HMBANA
milk banks, to discuss the safety, ethics, and regulatory
implications of donor human milk.

risks related to consumption of banked human milk and
how that varies depending on the source and processing

the voluntary or regulatory controls currently in place

Explore ideas related to additional scientific research that
might be needed to further advance our knowledge
concerning the risks
44
FDA PAC Hearing on Donor Milk fda.gov
The FDA Pediatric Advisory Committee endorsed
donor human milk banking and deemed informal
sharing of human milk to be unsafe
 See meeting agenda, briefing material and minutes
on the FDA website

45
HMBANA’s stance
v
“It does not condone, and in fact, questions the
practice of buying and selling of human milk as a
commodity. Introducing the profit motive could put
the infant of the lactating mother at risk if she feels
pressure to provide a certain volume of milk to a
bank or a recipient rather than feeding her own
infant. A medical institution, which is given incentives
to provide a specific volume of milk, may pressure
mothers of patients to become donors regardless of
their own infants’ needs. The recipient is also
potentially at risk if this perceived pressure motivates
a donor to adulterate her milk to increase volume.”
46
v
HMBANA position paper on
Heart of America
Mothers’ Milk Bank
at Saint Luke’s Hospital
 Group
began meeting in summer 2009.
 Barbara Carr, Christine Pai, Stephanie Howard, Lissa
Cross, Mary Grace Lanese; Katie MacFarland.
 Now includes Kristin Easter, Angie Moreno, Bonnie
Nelson, Judy Junk, Patrick Altenhofer, Sharon Wood,
Robin Evans
 Recognized a need within our community and an as yet
untapped resource.
47
Why have a milk bank in Kansas
City or anywhere else??
 Human
milk provides the best nutritional,
immunologic and developmental start for babies.
 It allows women in our area easier ability to
donate their milk.
 It allows NICUs in our area easier access to this
resource.
 Parents are aware of and beginning to expect
DHM as an option
 Women will seek it elsewhere—let’s make it
safe.
48
Heart of America Mothers’ Milk Bank
at Saint Luke’s Hospital
Our Mission
 To
provide donor human milk to premature and ill infants
by accepting, pasteurizing and dispensing human milk by
physician prescription.
 To educate the medical and general communities about
the indication for, benefits of, and use of donor human
milk.
 To increase the initiation and duration of breastfeeding in
the Kansas City regional area.
49
Heart of America
Mothers’ Milk Bank
at Saint Luke’s Hospital
 Member
of the Human Milk Banking Association of
North America (HMBANA)
 Initially functioned as a depot for Denver Mothers’
Milk Bank
 Began dispensing milk in Sept 2012
 Goal to bring donor depots on board over the next
several months
 Supply our region followed by the rest of the country
where needed
50
Heart of America Mothers’ Milk Bank
at Saint Luke’s Hospital
 Contact
info

“warm line” 816.932.4888

On the web at: www. saint-lukes.org

Email us at kcmilkbank@saint-lukes.org
51
Thank you
52
barbara_carr@pediatrix.com
Thank you
53
barbara_carr@pediatrix.com
Thank you
54
barbara_carr@pediatrix.com