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Vulnerable infants are at an increased risk for feeding intolerance due to immaturity or dysfunction (ie, congenital anomaly or obstruction) of the gastrointestinal system and/or hemodynamic instability. Symptoms of feeding intolerance include vomiting, water-loss stools, increased abdominal girth, and increased gastric residuals. It has been well documented that human milk provides optimal nutrition for infants and decreases the incidence of feeding intolerance. Donor human milk can be used for these at-risk infants to supplement the mother's own milk supply if insufficient or if the mother has decided not to or is unable to provide human milk for her infant. Establishing a donor human milk program within your institution will allow an opportunity for all vulnerable infants to receive an exclusive human milk diet.
One in 10 infants born in the United States is admitted to the neonatal intensive care unit (NICU), and human milk offers these infants specific benefits that will improve their health outcomes.1 Human milk decreases the incidence and severity of nosocomial infections and necrotizing enterocolitis (NEC) and improves visual acuity and neurocognitive outcomes in at-risk infants.2,3 Because of these benefits, the American Academy of Pediatrics recommends exclusive breastfeeding for the first 6 months of life and continued breastfeeding for a year or more with the introduction of solid foods.4 This article details the benefits of human milk, indications for donor human milk, the benefits of donor human milk compared with formula, the screening and processing of donor human milk, cost considerations, the use of human milk fortifier made from human milk, and the establishment of a donor human milk program within a hospital-based setting.
A brief overview of the immunological, nutritional, and developmental factors of human milk is provided. Immunological components of human milk, which are responsible for the prevention of infections as well as for the protection and maturation of the gastrointestinal tract, are [alpha]-lactalbumin, epidermal growth factor (EGF), immunoglobulin A, lactoferrin, lysozymes, oligosaccharides, and urea.5 The nutritional components, such as [alpha]-lactalbumin, casein, glucose, lactose, and sodium, provide optimal nutrition and energy for the infant.5 Developmental components include docosohexaenoic acid, arachidonic acid, EGF, and lactose. Both docosohexaenoic acid and arachidonic acid enhance growth, brain, and visual development.5
Since human milk has been shown to enhance gastric motility, the infant is able to absorb the nutrients more efficiently by increasing gastric emptying time.5 Other human milk properties stimulate gastrointestinal growth and maturation, as well as provide protection of the gastrointestinal mucosa. Secretory immunoglobulin A has a very specific role in relation to the gastrointestinal system of vulnerable infants. It has been shown to protect against pathogens in the gastrointestinal tract, thus decreasing the risk of feeding intolerance.5 Epidermal growth factor and pancreatic secretory trypsin inhibitor have been shown to repair gastric mucosa after injury.5,6Table 1 provides a summary of human milk components and their functions.
Vulnerable infants who require an NICU admission are at an increased risk for feeding intolerance due to prematurity, congenital anomalies, and/or hemodynamic instability. Feeding intolerance can present as abdominal distention, emesis and/or increased volume of gastric aspirates (bilious or nonbilious), bloody stools, loose or water-loss stool, metabolic acidosis, temperature instability, apnea, and/or blood glucose instability.7 A major cause of morbidity and mortality in the NICU is NEC. Infants receiving formula are 6.5 times more likely to develop NEC than those infants receiving human milk diets alone.7
A mother's own milk should always be the first choice for vulnerable infants, with donor human milk being the second choice. A mother's own milk has advantages over donor human milk, and donor human milk has significant advantages over infant formula.
For mothers with infants admitted to an NICU, a mother must rely on a hospital-grade double electric breast pump to initiate and maintain her milk supply. Although there have been advances in breast pump technology, pumping mothers may continue to struggle with low milk supply.8,9 For those mothers with low milk supply, donor human milk can be used to supplement the mother's own milk supply instead of formula to decrease the risk of feeding intolerance.10
In 2011, the Office of the Surgeon General report "The Surgeon General's Call to Action to Support Breastfeeding" encourages the establishment of evidence-based clinical guidelines for the use of banked donor human milk.11 These guidelines will allow health care professionals to easily identify vulnerable infants who would benefit from an exclusively human milk-based diet by using donor human milk and a pasteurized donor human milk-based human milk fortifier.11
The use of donor human milk has been demonstrated to decrease morbidity,10 nosocomial infections,7,12-14 NEC,7,12-15 urinary tract infections,7,12-14 gastroesophageal reflux disease,15 diarrhea,7,12-14 and length of hospital stay.4,13 In a systematic review by McGuire and Anthony14 that used 4 primary research studies, the authors concluded that infants who received donor human milk were 4 times less likely to have confirmed NEC than infants who received formula. The systematic review of Boyd et al16 examines the effects of donor human milk and formula in preterm infants.16 This systematic review included 16 articles from 7 studies including 5 randomized control trials. The combined evidence in this meta-analysis suggests that donor human milk reduces the risk of NEC by 79% (95% confidence interval).16 In settings where NEC rates range from 5% to 20%, 18.5 preterm infants would need to be fed donor human milk instead of formula to prevent 1 case of NEC.16
For infants with gastrointestinal-related diagnoses (ie, congenital anomalies, NEC, and short gut syndrome), the use of human milk and/or donor human milk should always be the first choice for nutrition due to the protective effects of human milk and decreased risk of feeding intolerance.5,12 Donor human milk should be used to supplement the mother's own milk supply instead of supplementing with formula or if the mother did not initiate pumping for her child.17
Human milk banks collect, pasteurize, store, and distribute the human milk that has been donated. There are currently 12 donor human milk banks across North America.18 The Human Milk Banking Association of North America (HMBANA) has strict guidelines to ensure that the donor human milk is both safe and maintains its nutritional components. Because human milk is a path of viral transmission, every mother who wishes to donate her human milk must be screened and meet the criteria set forth by HMBANA.11,18 Following a comprehensive verbal and written screen, all donor mothers undergo laboratory testing for HIV, hepatitis B and C, syphilis, and human T-lymphotropic virus. The expense of this testing is covered by the milk bank. Table 2 provides an overview of the human milk donation process and the HMBANA guidelines. Although HMBANA requires that its members adhere to these guidelines, they are not enforced by the Food and Drug Administration.
Donated human milk is mixed from various donors and placed in small jars for pasteurization. The milk is then treated by Holder pasteurization to eliminate viral and bacterial pathogens.19 Heat treatment does destroy lipases, B lymphocytes, and T lymphocytes; however, the majority of the beneficial components remain intact, including immunoglobulins and long-chain fatty acids.10,20 After pasteurization, each jar of donor human milk is cultured for bacterial growth. If bacteria are identified within that batch, it will be discarded.19
Human milk banks can process both preterm human milk and term human milk; therefore, a wide variety of vulnerable infants in the NICU can benefit. Preterm human milk varies from term human milk and has been shown to have an increased amount of calories, immunoglobulins, nitrogen, protein, lipids, medium-chain fatty acids, some vitamins, and trace elements.21 Also, increased levels of epidermal growth factor and enzymes have been identified, which, as previously stated, facilitate gastrointestinal maturation.10,22 The calcium level in the human milk of mothers of premature infants increases for the first 3 months.21 Sodium content is elevated in the beginning of milk production but decreases after 2 months.21 Potassium, phosphorus, and iron levels are also noted to be increased in preterm human milk.21 Therefore, it has been hypothesized that separating preterm and term human milk will provide preterm infants with improved nutrition, growth, and development.22 If extra fortification is needed to meet the nutritional needs of the infant, the process is completed within the hospital setting and not at the milk bank facility. Donor human milk demonstrates clear nutritional, immunological, and developmental benefits. However, the use of donor human milk is currently not routine in NICUs across the United States, and the cost of donor human milk may be considered to be a barrier. We present cost data that demonstrate that implementation and utilization of donor human milk are indeed cost-appropriate measures.
Hospitals or individuals purchase donor human milk directly from the human milk banks. It is important to note that the cost of donor milk comes from the extensive testing and processing that occurs. Currently, the price range is from $3.00/oz to $5.00/oz, with an average price of $4.50/oz (Human Milk Banking Association of North America, personal communication, November 3, 2011). Some milk banks charge more for preterm milk, with a range of $4.00/oz to $6.50/oz, average price of $5.00/oz (Human Milk Banking Association of North America, personal communication, November 3, 2011). Although preterm milk is available, it is usually in short supply. Because of supply concerns, preterm milk is predominantly used for severely premature infants who would require extra calories, calcium, and medium-chain fatty acids for growth and development.
In the last fiscal year at the Children's Hospital of Philadelphia (CHOP), $155,693.71 was spent on donor human milk. This cost reflects usage for an average of 9 to 11 patients per day and a range of 59 to 135 oz per day distributed. Considering the cost on a per-day or per-patient average, this equals to approximately $426 per day or $47 per patient. Comparing the cost of donor human milk with the average cost of total parenteral nutrition (TPN) at CHOP is astonishing.
On average, approximately $1436.46 is spent daily per patient receiving TPN. The range of cost varies on the volume of TPN needed, from $1044.02 for a 250-mL bag to $1990.19 for a 3000-mL bag. On any given day in the CHOP NICU, approximately 35 patients could receive TPN. On the basis of the average cost of TPN and the average number of patients, approximately $50,276.10 is spent per day. Therefore, approximately $18.4 million is spent per year on TPN. Research demonstrates that advancing feeds with human milk results in better feed tolerance; therefore, if more vulnerable infants received exclusive human milk feeds (mother's own milk or donor human milk), the amount of overall TPN need would be significantly reduced.
The per year donor human milk cost at our institution is a fraction of the cost of TPN, thus making economic sense to invest in the purchase of donor human milk for our infants. According to Wight,10 there is a possibility of an increased length of stay for any infant with feeding intolerance and the use of formula, and this is estimated to incur extra costs of approximately $9669 per infant. Considering the cost of donor human milk, approximately $8800 could be saved per infant.14 Reimbursement for the cost of donor human milk is unclear at this time. Hospitals are reimbursed for care of infants based on diagnosis (International Classification of Diseases, Ninth Revision, code) and not for the cost of individual treatment interventions such as donor human milk.
Necrotizing enterocolitis is an extremely expensive disease, with a minimum of an additional 14 days needed for treatment and an additional $46,200 added to the total hospital cost, based on an approximate charge of $3300 per NICU day.14 On the basis of these figures, it is apparent that the savings in hospital costs for each state would be in the millions. Approximately $74,004 per infant is used to treat medical NEC, and approximately $198,040 per infant is used to treat surgical NEC, based on the 2011 adjusted incremental cost.23
Most NICUs use traditional human milk fortifiers that are made from bovine milk. Clinicians have long been concerned that these fortifiers may pose the same risk of feeding intolerance and NEC as formula diet. Recent research suggests using pasteurized donor human milk-based human milk fortifier (ie, Prolact+H2MF) instead of bovine milk-based human milk fortifier (ie, Similac or Enfamil Human Milk Fortifier) to decrease the incidence of feeding intolerance and NEC. The price of Prolact+H2MF is approximately $6.25/mL, and, in many cases, insurance will cover the cost.23 If the insurance company is unwilling to cover the cost of Prolact+H2MF, many hospitals are willing to absorb the cost due to the cost savings when NEC is prevented.24 In a study, an exclusively human milk-based diet decreased medically treated NEC by 50% and surgically treated NEC by 90%.25 To prevent 1 case of medically treated NEC, 10 infants would have to receive an exclusive human milk diet.25 To prevent 1 case of surgically treated NEC, 8 infants would have to receive an exclusive human milk diet.25 The use of exclusive human milk diet would decrease NEC and save an estimated $138,000 to 238,000 per case.25
With the clear health benefits and potential cost savings, all NICUs should implement donor human milk programs. The first step in this process is to establish a hospital culture that values human milk and breastfeeding. Although 75% of women in the United States now initiate breastfeeding, exclusivity and duration rates remain alarmingly low, with less than 15% of infants receiving exclusive human milk for the first 6 months.26 Healthcare providers are a key barrier to improving the use of human milk and breastfeeding in the United States. The "Surgeon General's Call to Action to Support Breastfeeding" addresses key action items (#9 and #10) that call for the need for healthcare professionals to receive evidence-based breastfeeding education.17
Nurses should be the leaders of changing institutional culture surrounding breastfeeding and the use of human milk. In 2000, CHOP did not embrace human milk and breastfeeding; therefore, a comprehensive model for changing institutional culture was developed.27 Through the use of nurses and hospital-wide education and training, a culture was created that valued human milk, which allowed for implementation of a donor milk program since 2006.27 Breastfeeding resource nurses (BRNs) are the key change agents for implementation of human milk and breastfeeding initiatives. An ethnographic research study conducted in our unit at CHOP demonstrated that BRNs are the key components in supporting the pumping/breastfeeding mother in the NICU.28
The BRNs at CHOP serve as resources throughout the whole organization. At your institution, nurses should be identified to serve as human milk and breastfeeding champions. An effective way to do this is to establish a unit-based or hospital-wide breastfeeding committee. The committee can be responsible for education of staff members and implementation of practice change initiatives. At CHOP, the unit-based breastfeeding committee was responsible for all education surrounding the implementation of the donor human milk program and then, in turn, for education of families. A donor human milk policy was developed and reviewed by the hospital-wide breastfeeding committee. There is comprehensive intranet site available for all CHOP employees that explains the complete human milk donation process and donor human milk policy, which includes a Patient-Family Education sheet. This sheet reviews the importance of donor human milk, the role of HMBANA, the quality and safety of donor human milk, and the HMBANA donor screening criteria. This sheet provides valuable information to families and acts as a tool to facilitate questions and informed consent.
A key concept that must be emphasized is that mother's own milk is always preferred once enteral feeds are initiated. If the mother has a delay in the onset of milk production and/or a low milk supply or if the mother never initiated pumping, donor human milk should be the next option as opposed to formula. Table 3 provides recommended steps to assist facilities in establishing the use of donor human milk in their units.
To document potential need for human milk in your institution, determine the pumping initiation and continuation rate in your unit. Being able to document the human milk rate in your unit is essential to determine the average number of infants given infant formula. This will determine the amount of donor human milk needed, which should only be a small proportion of the total human milk usage in your unit, provided that you have created a culture that supports human milk and breastfeeding.
Once donor human milk needs are determined, contact HMBANA and establish a working relationship with a human milk bank of your choice. In our program, we established our relationship with the milk bank in closest geographic region to us; however, this is not essential. A fantastic way to initiate the relationship is to educate mothers about the ability to donate to the milk bank if they have excess human milk or in the event of infant demise.19 If you establish a working relationship in advance, it will make the process of ordering donor human milk for your institution seamless.
A point person must be determined to be responsible for ordering and maintaining inventory of the donor human milk. Accurate records of intake and distribution are essential for success. This will ensure that donor human milk is available at all times. A storage place must be identified for the donor human milk, including designated freezer space and a hood for milk preparation. In our institution, the donor milk program operates under the nutrition department and our donor human milk is prepared and delivered by trained technicians.
Physicians, advanced practice nurses, and nurses all have the opportunity to introduce the topic of donor human milk with families. In our institution, we elected to have families sign informed consent for the use of donor human milk. Once the consent is obtained, an order can be placed by the frontline clinician. The order is electronically sent to the formula room, and the trained technicians thaw the milk and individually dose it for each patient order. Donor milk is labeled with the patient's name, medical record number, the type of donor breast milk (term or preterm), any additives (fortification), and how many calories it contains. This label is double-checked to ensure that it matches the order. There is constant communication between the nursing staff and the technicians to ensure delivery of donor human milk on a timely basis, as well as measures to prevent wastage (eg, if the infant is fed nothing by mouth).
The literature is clear that human milk (including donor human milk) should be the first choice of enteral nutrition for all infants in the NICU. As nurses and advanced practice nurses, our job is to ensure the best evidence-based practice for the critically ill infants for whom we care. Donor human milk should be used as a supplement to mother's own milk or in place of infant formula in the NICU. The cost expenditures for such a program are real; however, when one considers the negative health and cost consequences of infant formula, donor human milk should be an option in every NICU across the nation.
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enteral nutrition; human milk; intensive care; milk banks; neonatal
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