donor human milk
DESCRIPTION
Donor Human Milk. Barbara L. Carr, MD, FAAP Medical Director Heart of America Mothers’ Milk Bank Medical Director Saint Luke’s Hospital of Kansas City NICU. 1. 2. Human Milk Banking Association of North America. Established in 1985 Mission - PowerPoint PPT PresentationTRANSCRIPT
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Donor Human MilkBarbara L. Carr, MD, FAAP
Medical Director Heart of America Mothers’ Milk Bank
Medical Director Saint Luke’s Hospital of Kansas City NICU
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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
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HMBANA
Consists of 14 operational banks 4 developing banks 1 mentoring bank
Dispensed: 2000 ~410,000 oz 2005 ~745,000 oz 2010 ~1.7 million oz 2011 ~2.2 million oz
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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
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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*.
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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.
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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
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Who receives it
Dispensed by prescription Infants, usually premature, in Neonatal
Intensive Care Units Limited outpatient use Some compassionate use pending availability
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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
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Nutritional Content
Preterm infants need ~120kcal/kg/d intake and 3.5-4g 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
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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.
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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.
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Benefits of Human Milk
Anti-infective sIgA Glycoproteins (oligosaccharides) Lactoferrin lysozyme
Anti-inflammatory Cytokines Platelet activating factor acetylhydrolase Transforming growth factor Beta
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Immunologic content
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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 environmentPreemies 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
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Immune system benefits of Human Milk
Oligosaccharides –the premier prebiotic encourage gI colonization of commensal bacteria
(bifidobacteria)-act to tighten mucosal barriers and compete for adherence sites
Bacterial 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; 25:37-58
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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, anti-inflammatory 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
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Anti-Inflammatory effects
High concentrations of LCPUFA Antioxidants (vitamin E, inositol, beta
carotene) Additional research particularly focusing on
oligosaccharides is ongoing.
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Immunologic content
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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
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Donor human milk, prevention of necrotizing enterocolitisMcGuire & Anthony, Arch Dis Child 88:F11 (2003)
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Donor milk and NEC in premature infants
DM p PF p MM (n=78) (n=88) (n=70)
Sepsis (%) 29 30 0.022 23NEC (%) 6 11 6BPD (%) 15 0.048 28 0.044 13Wt gain (g/kg/d) 17.1 0.001 20.1
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Schanler et al., Pediatrics 2005;116:400-406Note: All infants initially received their mother’s milk
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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
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Adjusted survival curves for NEC or death by proportion of HM to total intake over the first 14d of life (Meinzen-Derr et al)
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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
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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
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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.
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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)
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Use of Donor Human Milk at Saint Luke’s Hospital
Began as part of two quality improvement projects-part 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
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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
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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.
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Use of Donor Human Milk at Saint Luke’s Hospital
For infants <1500gDHM until 2kg
For infants 1500-2000gDHM 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)
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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 >2kgDonor colostrum (when available)
for initial feedings for infants <1250g
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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
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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.
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Barriers to using DHM
Availability – Lack of donors Competition-commercial use, informal sharing
(internet sales) Medical community Formula Perception of community
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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.
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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”
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Ounces of Milk Produced
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HMBANA’s stance
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FDAv 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
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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
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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.”
v HMBANA position paper on For Profit Milk Banking
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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.
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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.
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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.
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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
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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 [email protected]
