Clinical Information

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 a 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 is 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 more than 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 one case of NEC requiring surgery or resulting in death could be prevented for every eight 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 six-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. In that same year, 160 babies were diagnosed with NEC, with an average acute hospitalization cost of $517,299 per infant leading to the 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 milliliter of breast milk fed per kilogram 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.

Donor screening: safety and ethics

Donors are healthy lactating mothers who are willing to donate milk beyond their own baby’s needs. It is because of their generosity that we are able to provide our lifesaving service to the tiniest and most fragile residents of the Mid-Atlantic region.

We strictly follow the guidelines of HMBANA which include specific policies that ensure the well-being of the donors and their babies, as well as the donor milk. HMBANA prohibits donor compensation of any type due ethical and safety considerations.

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

1. Interview: An interview with a milk bank screener, 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 potential donor’s health care providers.
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 six months if an approved donor wishes to continue donation.

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 us (new medication, illness, etc.).

All donor screeners are nurses and/or lactation consultants (IBCLCs).

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. 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.

Due to lack of FDA regulation and research, preparations containing herbs (teas, capsules, vitamins, drinks, and shakes) are prohibited. This includes fenugreek and other galactogogues. Megadoses of vitamins 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. Mid-Atlantic Mothers’ Milk Bank has a Medical Advisory Board of regional experts which includes neontologists, pediatricians, and infectious disease specialists.

The importance of donor practices: know your milk bank

Donation practices are an important consideration when choosing a supplier of donor milk. Using a particular milk bank or company is support and endorsement of the practices of that organization. Exploitive and unethical policies, such as excessive ounce requirements or predatory recruitment practices can compromise donor milk safety and greatly impact the donor family, even undermining optimal nutrition for the donor’s own baby. When ethical, compassionate policies are in place, milk donation can be a very positive and rewarding experience for donors and their families.

We are as equally committed to our donor families as we are to our recipient families. If a mother under your care pursues donation, be assured that she and her milk will be cared for with respect and gratitude.

Important questions to ask about donor practices

Q: Are donors paid? If so, how much?
A: All donors are unpaid volunteers. The milk bank pays for all screening and shipping costs. Storage bags are available upon request. All HMBANA accredited milk banks are strictly prohibited from providing compensation to donors due to ethical and safety considerations.

Q: May I see your recruitment materials?
A: Absolutely! Download our donor info card. Be sure to review the Donor section of this site as well. Social media is a common way that donors find out about our milk bank. Check us out on Facebook, Instagram, and Twitter.

Q: Are mothers required to sign a contract?
A: Never.

Q: How many ounces are mothers required to donate?
A: Mothers are required to donate 150 ounces over several months. This minimum amount helps offset the costs of blood screening. There is no pressure for donors and they are told in writing and verbally that the needs of their baby and family always come before donation. The minimum amount is waived for bereaved donors.

Q: How do you know that a donor’s own baby is receiving all of the milk that he or she needs?
A: Our milk bank has policies in place to help ensure that the donor’s baby is receives all of the milk that he or she needs. The donor and the healthcare provider of the donor’s baby are asked specific questions regarding the donor’s supply and her baby’s growth. A donor’s baby’s human milk needs are always the first priority, even if the baby has weaned from the breast. Due to the reliance on self-reporting from mother to both the milk bank and healthcare providers, we avoid any incentivization of milk donation.

Q: What about bereaved donors?
A: Donation after a perinatal loss can be very healing for some families. We have several programs in place to support bereaved donors and their families. Please visit our Bereaved Families section for more information.

Milk testing and nutritional analysis

In addition to the testing required by Human Milk Banking Association of North America, Mid-Atlantic Mothers’ Milk Bank performs drug testing and macronutrient analysis on each milk pool.

Drug Testing

Milk Pools are tested for the presence of common substances of abuse including opiates, cannabis, and nicotine. Pools testing positive for any of these substances will be discarded.

Macronutrient Analysis

Mid-Atlantic Mothers’ Milk Bank uses the Miris Human Milk Analyzer, the first and only FDA approved device, to measure the macronutrient content of human milk. All milk pools are tested for kcal, protein, fat, and carbohydrate content.

Bacterial Culturing

Per Human Milk Banking Association of North America guidelines, a random bottle from each batch of pasteurized donor milk is sent for bacterial analysis. Mid-Atlantic Mothers’ Milk Bank uses a third-party certified lab to preform this critical testing. Batches that show any bacterial growth are discarded.

Pasteurization

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 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.

Processing: consideration of bioactivity

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 the 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 five minutes) 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.

Read a summary of the research regarding shelf stable products and bioactivity.

Storing and handling donor milk

Donor milk is stored frozen and transported by courier or shipped by FedEx for overnight delivery. We encourage all facilities to order a copy of HMBANA’s 2019 Fourth Edition of Best Practice for Expressing, Storing and Handling Human Milk in Hospitals, Homes, and Child Care Settings.

Accreditation

Mid-Atlantic Mothers’ Milk Bank is accredited and inspected by the Human Milk Banking Association of North America and follows all applicable state laws in its general service area of Pennsylvania, West Virginia, New Jersey, Maryland, and Delaware.  The milk bank is licensed in the Commonwealth of Pennsylvania and holds tissue bank licenses in Maryland and New York. Federally, donor milk is regulated as food processing, a designation requiring registration with the FDA and is subject to FDA inspection.

References

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