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Donor Human Milk

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

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Donor Human Milk

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  1. 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

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  3. 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

  4. 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 4

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  6. 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

  7. 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

  8. 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

  9. 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

  10. Who receives it • Dispensed by prescription • Infants, usually premature, in Neonatal Intensive Care Units • Limited outpatient use • Some compassionate use pending availability 10

  11. 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

  12. 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 12

  13. 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

  14. 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

  15. Benefits of Human Milk • Anti-infective • sIgA • Glycoproteins (oligosaccharides) • Lactoferrin • lysozyme • Anti-inflammatory • Cytokines • Platelet activating factor acetylhydrolase • Transforming growth factor Beta 15

  16. Immunologic content 16

  17. 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

  18. 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 18

  19. 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 19

  20. Anti-Inflammatory effects • High concentrations of LCPUFA • Antioxidants (vitamin E, inositol, beta carotene) • Additional research particularly focusing on oligosaccharides is ongoing. 20

  21. Immunologic content 21

  22. 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

  23. Donor human milk, prevention of necrotizing enterocolitis McGuire & Anthony, Arch Dis Child 88:F11 (2003) 23

  24. DM p PF p MM (n=78) (n=88) (n=70) Sepsis (%) 29 30 0.022 23 NEC (%) 6 11 6 BPD (%) 15 0.048 28 0.044 13 Wt gain (g/kg/d) 17.1 0.001 20.1 18.8 Schanler et al., Pediatrics 2005;116:400-406 Note: All infants initially received their mother’s milk Donor milk and NEC in premature infants 24

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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 31

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. Barriers to using DHM • Availability – • Lack of donors • Competition-commercial use, informal sharing (internet sales) • Medical community • Formula • Perception of community 38

  39. 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

  40. 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

  41. Ounces of Milk Produced 41

  42. HMBANA’s stance

  43. FDA • 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

  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

  45. HMBANA’s stance • “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.” • HMBANA position paper on For Profit Milk Banking 46

  46. 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

  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

  48. Heart of America Mothers’ Milk Bank at Saint Luke’s HospitalOur 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

  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

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