Donor human milk has emerged as the preferred substrate to feed extremely preterm infants, when mother’s own milk is unavailable. This article summarizes the clinical data demonstrating the safety, efficacy, and cost-effectiveness of feeding donor human milk to premature babies. It describes the current state of milk banking in North America, as well as other parts of the world, and the differing criteria for donor selection, current pasteurization techniques, and quality control measures. A risk assessment methodology is proposed, which would allow milk banks globally to assess the safety of their process and respond appropriately to differing risk environments.
Key points
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Provide evidence for the safety and efficacy of feeding donor human milk to premature babies.
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Review current milk banking practices in North America.
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Review the effects of long-term storage, handling, and heat treatment methods on various components of donor human milk.
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Describe risk management and quality control methods in donor human milk banking.
Introduction
Today in North America, there are 13 donor milk banks that make up the Human Milk Banking Association of North America (HMBANA). These banks are located in San Jose, CA; Denver, CO; Indianapolis, IN; Coralville, IA; Kalamazoo, MI; Raleigh, NC; Columbus, OH; Austin, TX; Fort Worth, TX; Kansas City, MO; Newtonville, MA; Calgary, Alberta; and Vancouver, BC, Canada ( https://www.hmbana.org ). Four more milk banks scattered throughout North America are currently in development and scheduled to open in 2013. These banks are not-for-profit entities. In 2006, Prolacta Bioscience, Inc (Monrovia, CA, USA), was founded as a for-profit entity to provide a commercial alternative to human milk banking, specifically, formulations of human milk designed for premature and critically ill infants ( http://www.prolacta.com ). Donor human milk is now being provided to patients throughout North America from both sources. Since the 1990s, with evidence of safety and increased amount of research on the clinical benefits of feeding donor human milk, milk banking has proliferated globally. Milk banking now exists in many countries, including Australia, Brazil, France, Germany, Italy, Switzerland, Norway, Finland, United Kingdom, Bulgaria, Slovakia, and South Africa.
In the United States, HMBANA is responsible for human milk banking practices and procedures, but there is currently no official federal oversight or regulation of milk banking. The original HMBANA guidelines were written in 1985, with input from the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA). All HMBANA milk banks function under the supervision of medical advisory boards. Prolacta Bioscience, Inc, reports following FDA regulations for both food and pharmaceuticals for their milk products. However, the FDA reviewed the practice of milk donor banking in the United States and decided against federal regulation of human milk banking ( http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm201871.htm ). Only a few states (eg, Texas) have regulations and state laws specifying guidelines related to procurement, processing, and distribution of human milk. New York and California have laws requiring milk banks to be licensed with the state before distributing milk, and California regulates milk banks in a manner similar to tissue banks.
In North America, not-for-profit milk banks (HMBANA) are generally community based or hospital based, function independently, and are operated with hospital or grant funding. Each bank charges a processing fee for dispensed donor milk, ranging from $3 to $5 per ounce. The milk banks serve not only hospitalized inpatients but also outpatients. Milk banks typically prioritize hospitals and neonatal intensive care units (NICUs) within their state but reach out to serve other states as well. For example, in the first decade of its existence the Mother’s Milk Bank of Austin served 56 hospitals and NICUs throughout Texas, 11 in Florida, 10 in Midwestern states, and 8 in South Atlantic states.
The greatest barrier to the use of donor human milk in NICUs is the lack of consensus among neonatologists regarding the efficacy of donor human milk feedings for all preterm babies. The cost borne by hospitals for purchasing the milk is another significant barrier, as whether or not private and/or Medicaid insurance coverage exists for donor milk varies from state to state. In addition, hospitals continue to express concerns about the availability of donor milk (especially preterm donor milk), the need for small aliquot volumes, the lack of uniform NICU-based milk preparation and fortification protocols, and the additional burden to the hospital, such as the necessity of tracking recipients and documentation of informed consent.
Introduction
Today in North America, there are 13 donor milk banks that make up the Human Milk Banking Association of North America (HMBANA). These banks are located in San Jose, CA; Denver, CO; Indianapolis, IN; Coralville, IA; Kalamazoo, MI; Raleigh, NC; Columbus, OH; Austin, TX; Fort Worth, TX; Kansas City, MO; Newtonville, MA; Calgary, Alberta; and Vancouver, BC, Canada ( https://www.hmbana.org ). Four more milk banks scattered throughout North America are currently in development and scheduled to open in 2013. These banks are not-for-profit entities. In 2006, Prolacta Bioscience, Inc (Monrovia, CA, USA), was founded as a for-profit entity to provide a commercial alternative to human milk banking, specifically, formulations of human milk designed for premature and critically ill infants ( http://www.prolacta.com ). Donor human milk is now being provided to patients throughout North America from both sources. Since the 1990s, with evidence of safety and increased amount of research on the clinical benefits of feeding donor human milk, milk banking has proliferated globally. Milk banking now exists in many countries, including Australia, Brazil, France, Germany, Italy, Switzerland, Norway, Finland, United Kingdom, Bulgaria, Slovakia, and South Africa.
In the United States, HMBANA is responsible for human milk banking practices and procedures, but there is currently no official federal oversight or regulation of milk banking. The original HMBANA guidelines were written in 1985, with input from the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA). All HMBANA milk banks function under the supervision of medical advisory boards. Prolacta Bioscience, Inc, reports following FDA regulations for both food and pharmaceuticals for their milk products. However, the FDA reviewed the practice of milk donor banking in the United States and decided against federal regulation of human milk banking ( http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm201871.htm ). Only a few states (eg, Texas) have regulations and state laws specifying guidelines related to procurement, processing, and distribution of human milk. New York and California have laws requiring milk banks to be licensed with the state before distributing milk, and California regulates milk banks in a manner similar to tissue banks.
In North America, not-for-profit milk banks (HMBANA) are generally community based or hospital based, function independently, and are operated with hospital or grant funding. Each bank charges a processing fee for dispensed donor milk, ranging from $3 to $5 per ounce. The milk banks serve not only hospitalized inpatients but also outpatients. Milk banks typically prioritize hospitals and neonatal intensive care units (NICUs) within their state but reach out to serve other states as well. For example, in the first decade of its existence the Mother’s Milk Bank of Austin served 56 hospitals and NICUs throughout Texas, 11 in Florida, 10 in Midwestern states, and 8 in South Atlantic states.
The greatest barrier to the use of donor human milk in NICUs is the lack of consensus among neonatologists regarding the efficacy of donor human milk feedings for all preterm babies. The cost borne by hospitals for purchasing the milk is another significant barrier, as whether or not private and/or Medicaid insurance coverage exists for donor milk varies from state to state. In addition, hospitals continue to express concerns about the availability of donor milk (especially preterm donor milk), the need for small aliquot volumes, the lack of uniform NICU-based milk preparation and fortification protocols, and the additional burden to the hospital, such as the necessity of tracking recipients and documentation of informed consent.
Management of donor milk banks
Within North America, milk banking guidelines and procedures are largely standardized and evidence-based. Donor selection occurs after careful characterization of the potential donor’s health history. Donors must be in good health, taking no medications or herbals and nursing an infant less than 1 year old. Lactating women who have extra milk after feeding their own infant or who have experienced perinatal loss donate to milk banks. Donor screening is rigorous and involves verbal and written questionnaires and laboratory serologic blood testing (cost, $150–$300 per donor) for human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-I and II, hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis, and tuberculosis. Donors with positive test results are excluded. Other donor exclusion criteria include high-risk behaviors for HIV, use of illegal drugs, smoking or use of tobacco products, drinking more than 2 alcoholic drinks per day, a history of organ or tissue transplant, any blood transfusion in the prior 12 months, tattoo or body piercing within the last 12 months, and past travel to UK for more than 3 months or to Europe for more than 5 months, from 1980 to 1996. These are the same donor exclusion criteria used by American Association of Blood Banks (AABB; www.aabb.org ). Prolacta Bioscience, Inc, uses some additional techniques for donor screening and quality control, including donor milk drug testing, DNA fingerprinting to ensure that the donor milk belongs to the screened donor, a cold chain delivery system and data logging technology, and polymerase chain reaction (PCR) testing for infectious agents in milk pools both before and after pasteurization.
Donor education for proper collection, storage, and transport of milk is paramount. In North America, donors are given instructions and specific protocols for expressing milk, proper hygiene, handling, and labeling. The milk is stored at −20°C in polyethylene containers and transported on dry ice, and long-term freezing at −20°C occurs at each milk bank. Frozen milk is later defrosted, pooled, and mixed, using universal precautions. Some milk banks conduct prepasteurization bacteriologic screening, which screens for donor technique and possible trends in colonization of pathogens. HMBANA milk banks perform heat processing with the Holder method using a commercial pasteurizer (62.5°C for 30 minutes). Prolacta Bioscience uses the high-temperature, short-time (HTST) pasteurization method (72°C for 16 seconds). All milk banks perform postpasteurization bacteriologic testing, which verifies pasteurization. No milk with any positive culture results after pasteurization is dispensed from HMBANA banks. Pasteurized milk is then chilled and stored for later use and dispensed with a physician’s prescription.
Factors affecting the safety of donor milk
Many factors influence the current safety of donor human milk. These include the nature of donor screening, donor honesty (about unknown medications or herbal exposure), potential infectious agents, milk changes from storage and preservation, milk component changes from heat treatment methods, and quality control of milk banking techniques. Infection risks associated with donor human milk feedings are thought to be negligible. There have been no reported cases of viral transmission or infection from the feeding of pasteurized donor human milk. However, many hospitals and neonatologists prefer to obtain informed consent for the remote possibility of infection and for the possibility of unknown drug or herbal exposure. Others assume donor milk feeding is the standard of care and obtain consent for its use only as part of the general consent for medical treatment.
Concerns remain regarding donor milk, as neonatologists aim to safeguard infants against the potential for exposure to pathogens, such as gram-negative organisms, methicillin-resistant Staphylococcus aureus , and group B beta-hemolytic Streptococcus . Neonatologists do not uniformly understand that mother’s own milk is frequently colonized with bacteria, nor do most know that pasteurized donor milk is dispensed as a sterile product. In fact, prepasteurization bacteriologic screening studies have shown that a wide variety of bacteria are present in donor human milk. However, Holder pasteurization is an effective means to remove any detectable bacteria from donor milk. In addition, pasteurized donor milk (without fortifiers or other additives) remains culture-negative for 24 hours after thawing and routine handling in the NICU. The HTST treatment method has also shown to be effective in eradicating pathogenic bacteria within the first 12 seconds of heating.
Physicians commonly express concern about possible viral transmission, especially cytomegalovirus (CMV) and HIV. Hamprecht and colleagues have compared the effects of 2 heat treatment methods (Holder vs HTST, in this study 72°C for only 5 seconds) on CMV infectivity and on milk components. Both heat treatment methods effectively inhibited CMV, as measured by PCR, CMV-RNA assay, and microculture assay for infectivity. Another study also found the HTST process to be highly effective in eradicating HIV and marker viruses for HBV and HCV.
Concerns have been raised about the adverse effects of milk storage and processing on the antiinfective properties of donor milk. Concentrations of immunomodulatory proteins (lysozyme, lactoferrin, lactoperoxidase, and secretory IgA) are reduced 50% to 80% by pasteurization, and to a lesser extent by frozen storage, when compared with fresh milk. The levels of other immunoactive cytokines (interferon, tumor necrosis factor, and interleukin) and many important growth factors (granulocyte colony-stimulating factor, hepatocyte growth factor, heparin-binding epidermal-like growth factor, transforming growth factor, and erythropoietin) are significantly reduced by Holder pasteurization. In addition, antioxidants are measurably altered by heat treatment. HTST pasteurization, when compared with Holder pasteurization, has been shown to be less harmful in reducing enzymes that mark the immunologic quality of the milk. Studies comparing heat treatment methods (Holder vs HTST) in their alteration of bactericidal and antioxidant capacities of human milk have shown that only short heating methods, 62°C to 72°C for 5 seconds, preserve the concentrations of growth factors in human milk.
Recommendations and current clinical uses of donor human milk
In 2003, the World Health Organization and United Nations Children’s Fund (UNICEF) recommended that for health situations where infants cannot or should not be breast-fed, the best alternative to expressed breast milk from an infant’s own mother is breast milk from a healthy wet nurse or human milk bank. American Academy of Pediatrics (AAP) policy supports the use of pasteurized donor milk when mother’s own milk is not available ( Box 1 ). Human milk banks in North America adhere to guidelines for quality control of screening and testing donors and pasteurize all milk before distribution. The AAP, CDC, and FDA do not recommend feeding fresh human milk from unscreened donors because of the risk of transmitting infectious agents.
- 1.
“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 for preterm infants, and it should be fortified appropriately for the infant born weighing less than 1,500 grams.”
- 2.
“If mother’s own milk is unavailable despite significant lactation support, pasteurized donor milk should be used.”
- 3.
“Quality control of pasteurized donor milk is important and should be monitored.”
Donor milk is most often used for the nutritional support of very premature infants and infants with malabsorption syndromes and/or severe feeding intolerance. Preventative uses include necrotizing enterocolitis (NEC) and inflammatory bowel disease. In North America, other common clinical therapeutic uses for donor milk include short gut syndrome (post-NEC), infectious diseases (acute gastroenteritis, sepsis, and pneumonia), postsurgical gut healing (omphalocele, gastroschisis, bowel obstruction, and intestinal fistulas), immunologic diseases (severe allergies and IgA deficiency), chronic renal failure, congenital heart disease, inborn errors of metabolism, and failure to thrive.
Clinical studies of donor milk use
A recent Cochrane Database systematic review of 8 randomized controlled trials found that feeding very preterm infants (<32 weeks gestation and <1800 g birth weight) formula compared with donor milk resulted in higher rates of growth in the short term. Weight gain, linear growth, and head growth were improved in infants fed formula compared with infants who received donor milk. There was no evidence of an effect on long-term growth rates or on neurodevelopmental outcomes.
Most compelling is the finding of this Cochrane review, as well as 2 other systematic reviews indicating a 4-fold increased risk of NEC in preterm or low birth weight infants fed formula compared with those fed donor human milk ( Table 1 ). Some of these older studies, however, did not include a large proportion of extremely premature infants, and nutritional protocols did not evaluate human milk fortifiers (HMFs) or contemporary preterm formula.
| Study Author, Year | Formula Milk | Donor Breastmilk | Weight | Risk Ratio (95% CI) |
|---|---|---|---|---|
| Gross, 1983 | 3/26 | 1/41 | 8.1% | 4.73 (0.52,43.09) |
| Tyson et al, 1983 | 1/44 | 0/37 | 5.7% | 2.53 (0.11,60.39) |
| Lucas et al, 1984 | 4/76 | 1/83 | 10.0% | 4.37 (0.50,38.23) |
| Lucas et al, 1984 | 5/173 | 2/170 | 21.0% | 2.46 (0.48,12.49) |
| Schanler et al, 2005 | 10/88 | 5/78 | 55.3% | 1.77 (0.63,4.96) |
| Total | 23/407 | 9/409 | 100% | 2.46 (1.19,5.08) |
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