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Position statement

CPS

Pasteurized and unpasteurized donor human milk

Posted: Dec 10, 2020

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Principal author(s)

Catherine M. Pound, Sharon Unger, Becky Blair; Canadian Paediatric Society, Nutrition and Gastroenterology Committee

Paediatr Child Health 2020 25(8):549. (Abstract).

Abstract

It is universally accepted that human milk is the optimal, exclusive source of nutrition for infants 0 to 6 months of age, and may remain part of the healthy infant diet for the first 2 years of age and beyond. Despite advances in infant formulas, human milk provides a wide range of benefits, due in part to its bioactive matrix that cannot be replicated by any other source of nutrition. When there is an insufficient volume of mother’s milk for the vulnerable newborn, pasteurized donor human milk should be made available, as a bridge to mother’s milk and as the first alternative feeding choice, followed by commercial formula. There is a limited supply of donor milk in Canada and distribution is prioritized for sick, hospitalized neonates. Informal milk sharing is the practice of donating and receiving expressed human milk without going through a human milk bank. Informal milk sharing carries risk for bacterial and viral transmission as well as inconsistency and uncertainty regarding donor screening. Paediatricians and other health care providers need to be aware of the risks of informal milk sharing and be able to counsel families appropriately on safer alternatives.

Keywords:  Breast milk; Donor milk; Human milk; Milk sharing

Pasteurized and non-pasteurized donor human milk

Human milk feeding, exclusively from 0 to 6 months of age, and prolonged human milk feeding with appropriate complementary feeding for up to 2 years and beyond, is the normal and unequalled method of providing nutrition for infants [1]. Human milk is species-specific and markedly superior to all alternatives for newborn feeding. Although cow-, goat- and soy-based formulas approach the fat, protein, and carbohydrate composition of human milk, they do not replicate the complexity or functionality of bioactive factors found in human milk. Breastfeeding or expressed human milk feeding helps ensure optimal growth [2][3], immune function [4]-[6], and neurodevelopment [7], at minimal financial cost to families. Benefits can be seen both in the short and longer term, with positive effects on child and maternal health [8][9].

Preterm and ill infants may not be able to feed directly at the breast from birth but can – with appropriate support – begin breastfeeding when they become developmentally ready or stable enough [10]. When feeding at the breast is not possible, the first choice is to feed expressed milk from the infant’s own mother [1]. When mother’s milk is not recommended, unavailable, or limited in volume despite lactation support, pasteurized donor human milk (PDHM) from a regulated milk bank is recommended for supplementary, bridging, or replacement feeding. Because the availability of PDHM is limited, informal unpasteurized donor human milk (UDHM) sharing [11] as an alternative to human milk substitutes (i.e., commercial formulas) is increasingly prevalent. A family’s decision to use UDHM may be based on the known health benefits of human milk, perhaps without being fully aware of the associated risks of this practice. Human milk sharing is often facilitated through Internet and community-based groups. Health Canada, the Canadian Paediatric Society, and the Human Milk Banking Association of North America (HMBANA) caution against the use of UDHM.

This position statement reviews the benefits of human milk in the preterm population, as well as the benefits of PDHM when a mother’s milk supply is insufficient. It also reviews the practice of UDHM sharing and provides guidance to physicians for counselling families.

Human milk for preterm and ill infants

There are almost 400,000 children born in Canada each year, and approximately 8% [12] of these newborns are born preterm. Human milk feeding is particularly important for preterm infants, and for those weighing <1500 g, breast milk should be fortified to ensure optimal nutrient intake [13]. Fortification involves supplementing the milk with specific macronutrients, vitamins, and minerals.

Studies have shown that infants who are fed human milk in the neonatal intensive care unit (NICU) may have fewer severe infections [14]-[16], less necrotizing enterocolitis (NEC) [17], and shorter stays in the NICU [18]. Human milk feeding has also been associated with a dose-dependent improvement in neurodevelopmental outcomes [19].

Pasteurized donor human milk

With proactive lactation support, PDHM can assist mothers to overcome difficulties with, or transition to, breastfeeding. Mother–infant dyads are often separated at the time of NICU admission, and this can sometimes be over long distances when infants must be transported to hospital away from their mothers for specialized care. Some mothers are unable to produce an adequate volume of milk for newborn feeding due to illness, stress, operative delivery, or medication [20], or because their mammary epithelium is insufficiently developed due to preterm delivery [21]. PDHM can then be used as a bridge until their own milk becomes available. PDHM, together with a mother’s milk, has been shown to significantly decrease the incidence of NEC [22][23]. Observational studies have also associated PDHM with improved feeding tolerance, shorter time to full feeds, and shorter length of hospital stay [22]. The short-term rate of weight gain and linear growth of preterm infants who are fed nutrient-fortified PDHM may be inferior to those fed preterm infant formula, but growth is unaffected over the longer term [23]. The use of PDHM does not discourage mothers from expressing their own milk. Rather, research has demonstrated that NICUs that provide breastfeeding support and have PDHM available have higher breastfeeding rates at discharge than units that do not offer PDHM [24]-[26].

Donor milk banks in Canada

In August 2020, there were four human milk banks in Canada: the B.C. Women’s Provincial Milk Bank, the NorthernStar Mothers Milk Bank in Alberta, the Rogers Hixon Ontario Human Milk Bank, and Héma-Québec’s Public Mothers’ Milk Bank. All Canadian public milk banks are operated on a not-for-profit basis and follow Health Canada’s regulations for food substances [27]. Three are members of the Human Milk Banking Association of North America (HMBANA) [28], which has established human milk processing guidelines for North America [29]. Each milk bank has a priority triage list for providing PDHM, first to inpatients, then to infants in the community when supplies allow, and depending on the bank.

The availability of PDHM depends on public donors who provide expressed milk for altruistic reasons. Before making their first donation, all potential donors must undergo a rigorous screening process that includes an interview, medical approval, and serological testing consistent with Canadian Blood Services practices. Women are only accepted as donors if they are seronegative for hepatitis B and C, human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV), and syphilis. Women are not accepted if they are taking medications (with some exceptions), consume alcohol, tobacco or cannabis, or use illicit drugs. They are temporarily excluded during periods of inter-current illness or over-the-counter medication use. Donors are educated about proper hand hygiene and human milk handling techniques. To donate to the milk bank, they may express one extra feed or multiple feeds per day (as might be the case with a bereaved mother). This milk is frozen, stored, and transported to the milk bank. For all milk banks except Quebec’s, a woman must donate a minimum of 150 to 160 ounces of milk in the first 18 months post partum. There is no minimum donation amount in Quebec.

There is significant variation in the macronutrient content of expressed human milk among individuals [30][31]. At the milk bank, milk is batched from different donors to standardize nutrient content. The milk is processed using Holder pasteurization (62.5°C for 30 minutes) in an industrial grade pasteurizer, then cultured after pasteurization. Any milk with a positive culture post-pasteurization is discarded. The milk is re-frozen while awaiting final culture results. When a hospital order for PDHM is received at the bank, milk is transported frozen, thawed on site at the recipient hospital, and dispensed as required. Careful records are kept to ensure that donors and recipients can be traced and all unconsumed milk recalled, if necessary.

According to the HMBANA guidelines, PDHM should only be dispensed after obtaining written informed consent from a parent or guardian. A written prescription from the medical provider is required beyond the initial feeds, and continuing supply may be prescribed for any infant when supplementation is medically indicated and PDHM is available.

Effects of pasteurization on human milk

The process of pasteurizing human milk deactivates bacterial and viral contaminants such as cytomegalovirus [32]-[34]. Spore-forming Bacillus species are known to survive routine Holder pasteurization but are detectable from the surveillance cultures performed after pasteurization [35]. As noted above, HMBANA guidelines require that donors be seronegative for hepatitis B and C, HIV, and HTLV, despite pasteurization’s ability to deactivate most viruses, including CMV, hepatitis B and C, HIV, and SARS-CoV-2 [36][37].

Many nutritional components of human milk are only minimally altered or reduced through pasteurization [38][39]. Some protein content is denatured, but fat-soluble vitamins remain relatively unchanged. While not all water-soluble vitamins have been studied in this context, folate and vitamin C have been shown to degrade during pasteurization [40]. Heating in pasteurization can significantly reduce biologically active proteins found in human milk [41]. Pasteurization decreases immunoglobulin A, which binds microbes in the digestive tract, and lactoferrin, which binds the iron required for growth by many bacteria, thereby suppressing their growth. Lysozyme enzyme, which attacks bacterial cell walls, also drops in activity [39].

Cost-effectiveness

The financial impacts of promoting breastfeeding and using PDHM in the NICU are difficult to estimate. One recent Canadian study found that total costs of supplementing mother’s milk with PDHM, for 90 days or until discharge from hospital, was equivalent to the costs of using pre-term formula [42]. Interestingly, there was a significant reduction in post-discharge costs for the PDHM group, which study authors believed to be driven by higher lost wages among caregivers of infants in the formula group [42]. The authors used the price of formula and fortifier paid by a participating neonatal unit in a ‘Baby-Friendly’ hospital to capture non-PDHM-related costs. The costs of processing PDHM are modest when compared with managing a single case of NEC or short bowel syndrome secondary to NEC.

A further collateral benefit of using PDHM and donor milk banks could be heightened community awareness of breastfeeding practices and options, with corresponding improved breastfeeding rates and benefits for population health [43].

Informal unpasteurized donor human milk sharing

Secondary to limited supply, PDHM is not readily available to healthy term infants who do not have access to their mother’s milk. PDHM distribution is prioritized for preterm and sick infants. Informal milk sharing refers to the practice of exchanging expressed human milk for infant feeding without a human milk bank being involved [44]. Informal milk sharing can occur in-community (peer-to-peer) or via the Internet [45] and is not subject to regulation or safety controls. There is some evidence that families are turning increasingly to informal milk sharing [46], perhaps in part because milk banks cannot provide milk for the general population [47]. Also, where PDHM is more available, it may be more expensive.

There are documented safety concerns about UDHM, including the lack of standardized donor screening and quality control processes, as well as an inability to control methods of milk storage and transportation [48]. Paediatricians and other health care providers (HCPs) should be aware that informal milk sharing occurs and be able to counsel families appropriately. The Canadian Paediatric Society (CPS), Health Canada, the U.S. Food and Drug Administration, and HMBANA, all discourage the practice of informal milk sharing.

Purchasing UDHM is particularly concerning when milk is obtained via the Internet without discussion or knowledge of the donor’s medical history. There are now published case reports of contaminated UDHM being purchased online from unscreened donors [49]-[51]. UDHM purchased over the Internet has reportedly been exposed to bacterial contamination [52] (notably Salmonella and Group B Streptococcus), as well as to viral transmission risk from cytomegalovirus (CMV), hepatitis, HIV, and HTLV [53]-[54]. In one U.S. study, 74% of samples acquired via the Internet contained bacteria levels (specifically Gram-negative bacteria, Staphylococcus species, coliforms, and Streptococcus species) that would fail HMBANA criteria [48], and 10% of samples had a concentration of bovine DNA high enough to suggest that cow’s milk product had been added to the sample [45]. These milk samples were purchased on the Internet, rather than donated, which may increase risk for tampering or contamination, similar to a phenomenon observed when blood donors are paid [55]. Other risks pertain to possible contamination with prescription and non-prescription drugs and pharmacologically active herbs.

In Canada, risk for HIV transmission through UDHM sharing is low but present. In 2017, only 240 infants were born to mothers with HIV, and over 96% of these women were being treated with anti-retroviral therapy [56]. However, CMV infection is common in Canadian women (at about 55%) [57], and virus may be present in UDHM. While CMV infection seldom harms healthy term infants, it can be a significant illness in those born preterm or immunocompromised [58].

Considerations

At-risk hospitalized neonates derive the most benefit from surplus human milk, with PDHM obtained from a human milk bank being the safest supply. HCPs can share this messaging with prospective, breastfeeding, or bereaved mothers, and encourage eligible donors to be screened before donating milk to an approved milk bank for processing and distribution to infants at greatest need.

As long as healthy babies do not have full access to PDHM from milk banks, informal milk sharing will likely continue [59]. One 2014 U.S. study estimated that 4% of women engage in informal milk sharing [47]. Online sharing networks connecting donors and recipients continue to grow, and milk sharing groups on social media are active in every Canadian province and territory.

While the CPS discourages informal milk sharing as potentially unsafe, paediatricians and other HCPs need to be aware of the practice and counsel prospective and new parents appropriately. The health risks of informal milk sharing should be raised with breastfeeding mothers, along with precautions to mitigate these risks. Should a family decide to share milk informally, counselling should include the following:  

  • Parents engaged in milk sharing must ensure that donors have tested negative for hepatitis B and C, HIV, HTLV, and syphilis, and are not at risk for ongoing exposure.
  • They must also make sure that prospective donors are not using illegal drugs, cannabis, tobacco products, or alcohol [45].
  • Donors should be in good health. They should not be taking any medications or supplements routinely, including herbs.
  • Donors should temporarily discontinue milk donation while experiencing an inter-current illness.
  • Parents must be thoroughly informed about safe handling and storage practices for human milk. The flash heating technique [45], which has been shown to deactivate HIV [60], could be one harm reduction strategy if parents source UDHM. However, parents should be made aware that human milk treated in this way may not be as nutritionally complete.

Recommendations

The best source of nutrition for newborns is their own mother’s milk. When unavailable or insufficient in volume, the best supplement, replacement, or ‘bridge’ for feeding sick or hospitalized newborns is pasteurized donor human milk (PDHM). The Canadian Paediatric Society does not endorse the sharing of unpasteurized donor human milk (UDHM). Infant formula, when needed, is considered the safer breast milk substitute for well newborns.

Paediatricians and other health care providers should:

  • Encourage and support mothers to breastfeed and to express their milk for infant feeding and, when possible, for milk bank donation.
  • Help optimize feeding plans for patients when a supplementary or alternate supply of human milk is needed. Support includes  seeking consent for PDHM when required, and explaining why PDHM is prioritized to sick or hospitalized newborns.
  • Ask parents whether they are considering use of (or are using) UDHM, and counsel on the risks associated with this practice, suggest safer alternatives, and discuss harm reduction strategies, as appropriate.
  • Advocate for additional donor milk banking programs in Canada to facilitate access to PHDM.

Human milk banks should engage in breastfeeding promotion and human milk research, including randomized trials to evaluate the benefits and risks of PDHM in populations other than preterm infants in intensive care.

Acknowledgements

The authors wish to thank Debbie Stone, RN IBCLC, with the Rogers Hixon Ontario Human Milk Bank, Debbie O’Connor, PhD, RD, with the Department of Nutritional Sciences at the University of Toronto, and Tanis R. Fenton, RD, MHSc, PhD, with the Department of Community Health Science, Alberta Children’s Hospital (Calgary). Their assistance with researching and editing this statement was invaluable. This position statement has been reviewed by the Community Paediatrics and Fetus and Newborn Committees of the Canadian Paediatric Society.

CANADIAN PAEDIATRIC SOCIETY NUTRITION AND GASTROENTEROLOGY COMMITTEE
Members: Linda M. Casey MD, Eddy Lau MD (Board Representative), Catherine M. Pound MD (Chair), Ana M. Sant’Anna MD, Pushpa Sathya MD, Rilla Schneider MD (Resident Member), Christopher Tomlinson MB, ChB, PhD
Liaisons: Sanjukta Basak MD, Canadian Pediatric Endocrine Group; Becky Blair MSc RD, Dietitians of Canada; Subhadeep Chakrabarti PhD, Bureau of Nutritional Sciences, Health Canada; Patricia D’Onghia MPH RD, Health Canada; Tanis R. Fenton PhD RD, Dietitians of Canada; Laura Haiek, Breastfeeding Committee for Canada
Principal authors: Catherine M. Pound MD, Sharon Unger MD, Becky Blair MSc RD

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Disclaimer: The recommendations in this position statement do not indicate an exclusive course of treatment or procedure to be followed. Variations, taking into account individual circumstances, may be appropriate. Internet addresses are current at time of publication.

Last updated: Feb 8, 2024

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