clinical information

the medical benefits of donor milk

Human milk optimizes the health, development, and well-being of all infants. Unfortunately, mother’s own milk is sometimes not available. The use of pasteurized human milk from carefully screened donors is a proven way to improve health care outcomes, promote breastfeeding success, and lower health care costs.

Donor Milk In The Neonatal Intensive Care Unit (NICU)

For medically fragile infants, an all human milk diet provides powerful, unparalleled protection against serious complications that can lead to longer hospitals stays, multiple procedures, life-long disability, or even death. Up to 70% of mothers who have infants in the neonatal intensive care unit (NICU) are unable to provide all of their baby’s needs1, at least initially, despite adequate lactation support and effort.

A large body of evidence has shown that the use of banked donor milk to achieve an all human milk diet when mother’s own milk is unavailable in the NICU setting can reduce mortality rates, lower healthcare costs, and shorten hospital stays while increasing rates of exclusive maternal breastfeeding upon discharge. The use of donor milk is specifically associated with lower rates of necrotizing enterocolitis, infections, sepsis, retinopathy of prematurity, and bronchopulmonary dysplasia.

The benefits of breast milk extend beyond the inpatient stay, with infants receiving all human milk diets in the NICU experiencing fewer hospital readmissions and better overall long-term outcomes.2

Preterm Infants

In the United States, one in nine infants are born prematurely (before 37 weeks gestation), one of the highest rates among developed countries. Premature and very low birth weight infants (those weighing less than 1.5 kg ) are especially vulnerable to complications in the NICU and particularly benefit from the anti-inflammatory and immunological components in human milk.

Due to this ever-growing evidence, the use of donor milk is rapidly emerging as the standard of care for very low birth weight infants in NICUs across the United States. In 2012, as part of its policy statement Breastfeeding and the Use of Human Milk, the American Academy of Pediatrics stated “The potent benefits of human milk are such that all preterm infants should receive human milk. Mother’s own milk, fresh or frozen, should be the primary diet, and it should be fortified appropriately for the infant born weighing less than 1.5 kg. If mother’s own milk is unavailable despite significant lactation support, pasteurized donor milk should be used.”3

Necrotizing Enterocolitis

Most notably, an all human milk diet dramatically reduces the risk of necrotizing enterocolitis (NEC), an inflammation of the intestine that is the most prevalent gastrointestinal emergency among preterm infants. Up to 10 -12% of infants born significantly premature develop NEC and will suffer both short-term and long-term health consequences. While all premature infants have an elevated risk for NEC, those with very low birth weight are at particular risk. Newborns with certain forms of congenital heart disease are also at an increased risk for NEC, regardless of gestational age.4

Half of infants with NEC require surgery to remove the affected intestinal tissue. Of these, 25% will develop short gut syndrome, a condition where there is not sufficient intestinal tissue for adequate absorption of nutrients.

NEC has a 24% mortality rate among infants who develop non-surgical NEC, and a 40% mortality risk among infants who require surgery. NEC continues to require resources to alleviate long-term problems associated with the disease, including intestinal obstructions, failure to thrive, feeding abnormalities, short gut syndrome, parenteral nutrition-associated liver disease, and poor neurodevelopmental outcomes.

Human milk is uniquely designed for the newborn gut and provides robust protection. One study found that just 50% human milk feeding in the first 14 days of life was associated with a six-fold decrease in the odds of NEC.5 This protection appears to be dose dependent, with NEC rates increasing as the proportion of formula in the diet increases.6 Infants fed a formula-based diet were shown to have 3.5 times greater risk for developing NEC, and exposure to any amount of formula increases risk.7 Similar increase was found by Cochrane 2014 with a formula-based diet elevated NEC risk by 2.77 times.8

An exclusive human milk diet has been shown to decrease the overall incidence of NEC by up to 80% and the rate of surgical NEC by over 90%. Those infants who acquire NEC despite having an all human-milk diet have a much more benign course of disease, recovering quickly and rarely requiring surgery.9,10,11,12,13

It is estimated that one case of NEC could be prevented for every 10 infants receiving an all human milk diet, and 1 case of NEC requiring surgery or resulting in death could be prevented for every 8 infants receiving an all human-milk diet.14

Increased Feeding Tolerance

Total Parenteral Nutrition (TPN) refers to intravenous feeding, bypassing the usual process of eating and digestion. TPN is often required in infants at 30 weeks gestation or below and in infants with certain gastro-intestinal conditions. TPN is hard on the body, costly, and is associated with vascular, hepatic, and infectious complications.

Human milk, whether maternal or donated, is associated with quicker tolerance of oral feeds, eliminating the need to initiate TPN feeding in 11-14 % of premature infants or reducing the number of days on TPN.15

Human milk feeding has been associated with improved outcomes and less time on TPN16 for infants with short gut syndrome and other gastrointestinal issues. In a study of 272 infants with intestinal failure who where followed for 27.5 months, breast milk fed infants were on TPN for an average of 290 days vs. 720 days of TPN for infants not receiving breast milk.17

Length of Stay

One study found that premature infants who are fed an exclusive human milk diet are discharged, on average, 14 days sooner than infants receiving formula or a combination of breast milk and formula.18

In an analysis of 207 VLBW infants, an exclusive human milk diet was shown to save 3.9 NICU days.13

Increases Rate of Maternal Breastfeeding

Nothing compares to mother’s own milk as it is specifically designed for her infant’s individual needs. Donor milk is meant to be a support to breastfeeding with the ultimate goal being the provision of mother’s own milk.

In the NICU setting, the use of donor milk is associated with increased rates of exclusive maternal breastfeeding at discharge.19 In an analysis of individual clinical data in the state of California from 2007-2013, the provision of donor milk was found to be associated with lower NEC rates and higher rates of maternal breast milk feeding at discharge.20

When a NICU starts a new donor milk program, the subsequent increase in maternal milk can be quite dramatic. Boston Medical Center looked at the use of mother’s own milk (MOM) in VLBW infants for the two years prior to (N=74) and the two years after (N=80) the introduction of donor milk to the NICU. A 6-fold increase in the consumption of MOM and a 49% reduction in the cessation of MOM during the hospital stay was found after initiation of the donor milk program.21

Health Care Cost Savings

The use of donor milk for supplementation to achieve an exclusive human milk diet prevents some of the costliest complications in the NICU setting. The overall cost of preterm birth in the United States is at least $26 billion per year22, and Medicaid finances half of these healthcare costs.23 A large portion of these costs relate to both acute and long-term complications experienced by preterm infants, many of which are prevented or alleviated through exclusive human milk feedings.

According to the Pennsylvania Health Care Cost Containment Council, 2,029 very low birth weight infants were born in Pennsylvania in 2015. One hundred sixty babies were diagnosed with NEC in that same year, with an average acute hospitalization cost of $517,299 per infant leading to the 2015 burden of NEC in the state of Pennsylvania exceeding $80M.

On average, a case of medical necrotizing enterocolitis results in $74,004 of additional care, and one case of surgical necrotizing enterocolitis adds $198,040 or more to the cost of care.13 It is estimated that NEC results in $5 billion of hospitalizations per year and approximately 19% of neonatal healthcare expenditures in the United States.18

The healthcare costs of NEC extend well beyond the initial hospitalization and newborn period. In a review of 50 surgical NEC survivors and 50 matched controls enrolled in the Texas Medicaid program born between 2002 and 2003, children with a history of NEC continued to have elevated health care costs at age three. The mean incremental healthcare costs of the surgical NEC infants compared to controls between 6-12, 12-24, and 24-36 months of age were $18,274, $14,067 and $8,501 per infant per six-month period, respectively.24

In an analysis of just the small subset of extremely low birth weight babies (ELBW) born at 1000g, failure to provide optimal breast milk feeding was estimated to result in $21.1 million in direct medical costs, $563,655 indirect medical costs, and $1.5 billion in costs due to premature death.10

In a study of 291 VLBW infants, it was found that each ml of breast milk fed per kg per day in the first 14 days of life saved $534 in non-NEC related NICU costs.25

It has been estimated that for every $1 spent on banked donor milk, $11 of health care costs due to length of stay, NEC, and sepsis reductions can be saved.26 In an analysis of 207 VLBW infants, an exclusive human milk diet was shown to save $8,167.17 per infant.13

Donor Milk In the Mother Baby Unit

Donor milk can play a vital role in the support of breastfeeding in the Mother Baby Unit. In addition to avoiding risks of formula introduction, the availability of donor milk for medically necessary short-term supplementation is associated with higher rates of maternal breastfeeding and is an option much appreciated by families.

In a survey of 71 hospitals in Northeastern United States, 29% of the birth hospitals in Massachusetts and 43% of hospitals served by the milk bank in Massachusetts (representing several states) used donor milk in their well-baby population. Hospitals that used donor milk for healthy newborns had higher rates of maternal exclusive breastfeeding (77% versus 56%), and 83% of the responding hospitals viewed donor milk as an effective way to increase the hospitals’ exclusive breastfeeding rate.27

In an analysis of interviews of 30 postpartum breastfeeding mothers whose infants were given supplemental feedings of donors milk and/or formula, donor milk was found to be perceived as “healthier” and “temporary” whereas formula was seen as ongoing. (Kair, 2017)

Outpatient Donor Milk Use

Donor milk may also be used by infants cared for at home with a variety of conditions. Approximately 25% of the Milk Bank’s volume is used by outpatients at this time. Common diagnoses include cardiac conditions, immune disorders, inborn errors of metabolism, formula intolerance, malabsorption disorders, post-surgical nutrition, renal disease, short gut syndrome, failure to thrive, organ transplantation, and neonatal abstinence syndrome.

Safety: Screening and Processing
Screening

Mid-Atlantic Mothers’ Milk Bank strictly follows the guidelines of the Human Milk Banking Association of North America.

Donors are simply healthy lactating mothers who are willing to donate milk beyond their own baby’s needs. HMBANA prohibits donor compensation of any type due to the introduction of ethical and safety concerns.

Donors go through a thorough four-part screening process that includes:

  1. Interview: An interview with a milk bank screener (nurse and/or lactation consultant), which includes questions regarding medication/supplement use, risk factors for blood borne illnesses, travel, and medical history that pertain to common reasons for deferment.
  2. Completion of the Application Packet: The packet is completed online or sent by mail. The application contains more detailed information regarding medical history, medications, diet, pregnancy, and birth.
  3. Statements of Health: A one page “statement of health” is faxed to the health care providers of both the potential donor and her baby.
  4. Bloodwork: If no reasons for exclusion are found in steps 1-3, the potential donor goes through blood screening which includes HIV, HTLV, Syphilis, and Hepatitis. Currently, the milk bank contracts with Quest Diagnostics and CORE to ensure that all donors in the region have a convenient option for blood testing. Blood work is repeated in 6 months if an approved donor wishes to continue donation (the milk bank accepts milk pumped on or before the baby’s first birthday).

The Milk Bank’s screeners stay in close contact with donors throughout the time that they donate. Donors are given instructions regarding pumping hygiene, storage, and when to contact the Milk Bank (new medication, illness, etc.). At a minimum, donors are contacted every two months.

Common Reasons for Donor Deferment or Exclusion

Given the fragility of the population served by milk banks, extra precautions are taken to ensure safety.

The most common reasons for deferment are medication and supplement use. Anti-hypertensives are prohibited and are a common reason for deferment for donors with babies in the NICU setting. Certain anti-depressants and other medications, both prescription and OTC, are compatible with donation. Thyroid medication is generally acceptable. The Milk Bank maintains an updated list of acceptable medications.

Preparations containing herbs, (teas, capsules, vitamins, drinks, and shakes) are prohibited. This includes fenugreek and other galactogogues. Megadoses of vitamins, exceeding 20x the RDA, are also prohibited.

Active treatment of certain chronic illnesses is another common issue. Deferments are typically due to medications, not the illness itself.

HMBANA’s Guidelines Committee meets regularly to assess new medications and screening related concerns. The Milk Bank itself has a medical advisory board of regional experts which includes, neontologists, pediatricians, and infectious disease specialists. Please visit About Us for a list of Medical Advisory Board members.

Pasteurization Process

Human milk is a bio-active, dynamic tissue that provides the perfect nutrition for newborns. The less processing of milk, the better. The Holder Method of Pasteurization (62.5 °C for 30 minutes), which is the only method approved by the HMBANA, eliminates pathogens while retaining much of the bioactivity and important components of human milk.

Milk processing begins with thawing frozen milk overnight in refrigerators. The milk of up to five donors is pooled together to even out nutritional variations and to increase the immunological profile of the milk. Pooled milk is gently mixed and poured into BPA free bottles with tamper resistant caps. Filled bottles are pasteurized in a hot water bath using automated human milk pasteurizers from ACE Intermed.

A random bottle from each processed batch is sent for bacterial culturing. If a batch shows any growth it is discarded.

For a visual explanation of the process, please visit How It Works.

Consideration of Bioactivity- Pasteurization Versus Sterilization

Human milk is not just calories and protein. It contains bioactive components that provide important immunological and microbiome support. While raw milk is best, the fragility of the population served by milk banks necessitates elimination of pathogens. Retention of bioactive properties is an important consideration in human milk processing, and Holder Pasteurization is one of the best ways to ensure safety while minimizing the destruction of essential human milk components.

Pasteurization refers to a relatively low heat treatment that destroys pathogens. It does not eliminate all of the vegetative microbial population, so pasteurized foods must be refrigerated or frozen to minimize microbial growth. Commercial sterilization involves subjecting food to a high temperature for a sufficiently long time to eliminate all forms of microorganisms and destroy or inhibit enzymes.

Retort sterilization is widely used in food production to create shelf stable storage. This high heat, short time process that requires temperatures above boiling has recently been used for donor milk (121°C for 5 min) processing. While retort sterilization is a very effective way to eliminate bacteria, new studies suggest that retort processing may significantly alter, or even eliminate, bioactive components that are important for the immune system and microbiome.

In one study, retort processing reduced secretory immunoglobulin A by 90% versus just a 10% reduction with the Holder Method. 65% of lysozyme activity was retained in human milk pasteurized by the Holder Method, and no lysozyme activity was detected in human milk that underwent retort processing.29  An analysis of random samples from three different milk banks, showed that samples that had undergone retort sterilization had significantly less immune-protective proteins and total and specific human milk oligosaccharides (HMOs).30 Another study showed dramatically decreased sIgA (90% reduction for Retort, 10% reduction for Holder) and lysozyme (100% reduction for Retort, 45% for Holder) bioactivity in human milk subjected to retort processing activity.31

References
  1. Caroll K, Herrmann KR.  The cost of using donor human milk in the NICU to achieve exclusively human milk feeding through 32 weeks postmenstrual age. Breastfeed Med. 2013;Jun 8(3):286-90.
  2. Vohr BR, Poindexter,B, Dusick. Beneficial Effects of Breast Milk in the Neonatal Intensive Care Unit on the Developmental Outcome of Extremely Low Birth Weight Infants at 18 Months of Age. Pediatrics.2006; Jul 118(1):115-123.
  3. Section on Breastfeeding, American Academy of Pediatrics (AAP). Breastfeeding and the Use of Human Milk. Pediatrics 2012;129(3):e827-e841.
  4. McElhinney DB, Hedrick HL, et al. Necrotizing enterocolitis in neonates with congenital heart disease; risk factors and outcomes. Pediatric. 2000;106(5):1080-1087.
  5. Sisk PM, Lovelady CA, Dillard RG. Early human milk feeding is associated with a lower risk of necrotizing enterocolitis in very low birth weight infants. Journal of Perinatology 2007;27:428–433.
  6. Meinzen-Derr J, Poindexter B, Wrage L. Role of human milk in extremely low birth weight infants’ risk of necrotizing enterocolitis or death. Journal of Perinatology 2009;29:57–62.
  7. Johnson TJ, Patel AL, Bigger HR, Engstrom JL, Meier PP. Cost savings of human milk as a strategy to reduce the incidence of necrotizing enterocolitis in very low birth weight infants. Neonatology 2015;107(4):271 – 76.
  8. Quigley M, McGuire W. Formula versus donor breast milk for feeding preterm or low birth weight infants. Cochrane Database of Systematic Reviews 2014, Issue 4. Art. No.: CD002971. DOI: 10.1002/14651858.CD002971.pub3.
  9. Boyd CA, Quigley MA, Brocklehurst P. Donor breast milk versus infant formula for preterm infants: systemic review and meta-analysis.  Arch Dis Child Fetal Neonatal Ed.  2007;May 92(3):169-75.
  10. Colaizy TT, Bartick MC, Jegier BJ. Impact of optimized breastfeeding on the costs of necrotizing enterocolitis in extremely low birthweight infants. .J Pediatr. 2016;Aug(175):100-105.
  11. Cristofalo EA, Schanler RJ, Blanco CL, Sullivan S, et al.  Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants.  J Pediatr. 2013; Aug 20.
  12. Chowning R,Radmacher P,Lewis S. A retrospective analysis of the effect of human milk on prevention of necrotizing enterocolitis and postnatal growth. Journal of Perinatology2016;Mar(36): 221-224.
  13. Ganapathy V, Hay JW, Kim JH. Costs of necrotizing enterocolitis and cost-effectiveness of exclusively human milk-based products in feeding extremely premature infants.  Breastfeed Med. 2012; Feb (1); 29-37.
  14. Sullivan S, Schanler RJ, Kim JH, et al.  An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products Pediatr.2010;Apr 156(4):562-7.
  15. Ghandehari H, Lee ML, Rechytman DJ. An exclusive human milk-based diet in extremely premature infants reduces the probability of remaining on total parenteral nutrition: a reanalysis of the data. BMC Research Note s2012 5:188.
  16. Andorsky, DJ. Nutritional and other postoperative management of neonates with short bowel syndrome correlates with clinical outcomes. J Pediatr. 2001;Jul;139(1):27-33.
  17. Squires RH et al. Natural history of pediatric intestinal failure: initial report from the Pediatric Intestinal Failure Consortium. J Pediatr 2012;Oct;161(4):723-728.
  18. Bisqueria JA, Cooper TR, Berseth CL. Impact of necrotizing enterocolitis on length of stay and hospital charges in very low birth weight infants. Pediatrics 2000; 109(3):423.
  19. Arslanoglu S, Moro GE, Bellu R, et al. Presence of human milk bank is associated with elevated rate of exclusive breastfeeding in VLBW infants.  Perinat Med.  2013 Mar 41 (2).  129-131.
  20. Kantorowska A,Wei JC,Cohen RS. Impact of donor milk availability on breast milk use and necrotizing enterocolitis rates. Pediatrics 2016 Feb.
  21. Parker MGK, Burnham L, Mao W. Implementation of a donor milk program is associated with greater consumption of mothers’ own milk among VLBW infants in a US, level 3 NICU. J Hum Lact May 2016 vol. 32 no. 2221-228.
  22. Institute of Medicine (US) Committee on Understanding Premature Birth and Assuring Healthy Outcomes; Behrman RE, Butler AS, editors. Washington (DC): National Academies Press (US); 2007.
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  24. Ganapathy V, Hay JW, Kim JH. Long term healthcare costs of infants who survived neonatal necrotizing enterocolitis: a retrospective longitudinal study among infants enrolled in Texas Medicaid. BMC Pediatrics 2013 13:127.
  25. Johnson TJ, Patel AL, Bigger HR. Cost savings of human milk as a strategy to reduce the incidence of necrotizing enterocolitis in very low birth weight infants. Neonatology 2015;107:271-276.
  26. Wight N. Donor human milk for Preterm Infants. Journal of Perinatology Jun2001, Vol. 21 Issue 4, 249-55.
  27. Belfort MB, Drouin K, Riley JF., et al. Prevalence and trends in donor milk use in the well-baby nursery: a survey of Northeast United States birth hospitals. Breastfeeding Medicine. October 2017, ahead of print
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  29. Lima, HK, Wagner-Gillespie, M, et al. Effect of Holder Pasteurization and retort processing on bioactive components and nutritional content of human milk. The FASEB Journal 2017;31(1).
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