Early Human Development 85 (2009) 701–704

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Early Human Development

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The knowns and unknowns of human milk banking

Karen Simmer a,b,⁎, Ben Hartmann b

a University of Western Australia and Women, WA, Australiab Perron Rotary Express Milk Bank (PREM Bank), King Edward Memorial Hospital, Subiaco, WA, Australia

⁎ Corresponding author. School of Women's andWestern Australia, M550. 35 Stirling Hwy, Crawley WA

E-mail address: karen.simmer@uwa.edu.au (K. Simm

0378-3782/$ – see front matter © 2009 Published by Edoi:10.1016/j.earlhumdev.2009.08.054

a b s t r a c t

a r t i c l e i n f o

The PREM Bank has been providing pasteurised donor human milk (PDHM) to very preterm for the past3 years. It is the first human milk bank (HMB) to operate in Australia in over 20 years. Our community hasrapidly embraced the concept of human milk banking, with both donations and demand for PDHM exceedingexpectations. Providing PDHM in ‘exceptional circumstances’ where a mothers’ own milk is unavailable issupported by the WHO and UNICEF. We submit that neonatal intensive care is an exceptional circumstance.Although evidence supporting PDHM use from randomised control trial (RCT) is limited, the latestsystematic reviews suggest a lower risk of necrotising enterocolitis with PDHM as opposed to artificialformula. Study design and ethical issues may limit future evidence from RCT. We therefore support theongoing use of PDHM in neonatal care, where provided by an appropriately managed HMB.Internationally many HMBs operate unregulated, and this is also the case in Australia. To ensure safetythe PREM Bank has committed to meet the appropriate standards recommended in the Code ofGood Manufacturing Practices (Blood and Tissues) in Australia and models risk management duringprocessing on Codex HACCP (Hazard Analysis Critical Control Point) requirements. There is scope tocontinually re-evaluate the screening of donors and quality standards recommended during HMB. This willbe most effective if strong networks of HMBs are developed with regional reference laboratories toencourage compliance with safety guidelines. HMB networks will facilitate collection of evidence for refiningHMB practice and improving outcomes for preterm and sick infants.

© 2009 Published by Elsevier Ireland Ltd.

1. Introduction

In July 2006 the Perron Rotary Express Milk (PREM) Bank wasestablished at King Edward Memorial Hospital in Perth, WesternAustralia (WA). This marked the re-establishment of human milkbanking in Australia since its cessation in the mid 1980s due to theidentification of human immunodeficiency virus (HIV) in humanmilk.During the establishment phase, and now, after 3 years of humanmilkbanking, we have had the opportunity to re-assess what is known andremains unknown in regard to human milk banking. This paperdocuments the current state of knowledge and suggests directions forthe future development of this aspect of neonatal care.

Somewhat to our surprise, we have quickly discovered that thecommunity love human milk (HM) banks (HMB). Our experience, inAustralia, has been that media interest is limitless and almostexclusively positive. We have also found that mothers experiencingan oversupply actively seek us out and, as such, donations havealways exceeded our processing capacity. We now also know that

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neonatal staff prefer to prescribe pasteurised donor human milk(PDHM) rather than, formula as shown by 530% increase in use sincethemilk bank opened inWA (averaged over 12 months for the 3 yearsof operation). On average in 2009, we have fed nine patients, 1.7 l ofPDHM per day. Importantly, we now know that parents of preterminfants welcome PDHM when mother's own milk (MOM) supply isinadequate with only a few mothers refusing. Although there hasbeen a dramatic increase in donor milk use in our neonatal intensivecare unit (NICU) since the establishment of the PREM Bank we haveshown through audit that, opening a HMB does not reducebreastfeeding or expressing rate. Overall breastfeeding rates atdischarge in 2008 were 75% (this is higher than previous audit). Ofthose who received PDHM, breastfeeding rates at discharge were 72%.

We also know that our experience is not unique and that theWorld Health Organisation and UNICEF have jointly supported theestablishment of human milk banking as part of international effortsto promote and support breastfeeding: “Only under exceptionalcircumstances can a mother's milk be considered unsuitable for herinfant. For those few health situations where infants cannot, or shouldnot, be breastfed, the choice of the best alternative—expressed breastmilk from an infant's own mother, breast milk from a healthy wet-nurse or a humanmilk bank, or a breast milk substitute fed with a cup,which is a safer method than a feeding bottle and teat—depends on

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individual circumstances”, WHO UNICEF Global Strategy for Infantand Young Child Feeding [1]. HMB is also referred to by the AmericanAcademy of Pediatrics [2] as a suitable alternative when a mother'sown milk is insufficient or unavailable.

Despite the long history of human milk banking, evidence fromrandomised clinical trial (RCT) is limited and includes trials in India byNarayanan [3], in England by Lucas [4], and in USA by Schanler [5].Narayanan [3] randomised preterm infants to raw or pasteurised HM+/− formula and demonstrated pasteurisation reduced the protec-tive effects of HM (14.3% infection v 10.5%) but infants fed PDHM hadlower infection rates than those fed formula (33.3%). Lucas [4]randomised 502 infants weighting <1850 g PDHM or pretermformula (PTF) and demonstrated similar developmental scores(Bayleys) at 18 m which they interpreted as PDHM conferringadvantage that was offset by the relatively deleterious effects of lownutrient content. The authors concluded that it is logical to combinethe benefits of HM with that of extra nutrition provided in fortifiers.Schanler [5] randomised infants 23–29 weeks gestation being fedMOM to PDHM or PTF once tolerating >50 ml/kg/d if MOM supplywas inadequate. Intention—to treat analysis with 21% PDHM beingswitched to PTF for poor growth and infants still receiving 50% MOM,showed no benefit of PDHM in primary end-point of late-onset sepsisand/or necrotising enterocolitis (NEC). The study design and samplesize have been criticised and the authors agree further studies arerequired. Meta-analysis of randomised trials of PDHM v PTF found alower risk of confirmedNECwith PDHM (as entire feed RR 0.25, 95% CI0.06–0.98, as supplemental feed RR 0.3, 95%CI 0.11–0.87)[6].

It is unlikely that future evidence for HMB will come exclusivelyfrom RCT of PDHM. Clinicians working in NICU's with access to donormilk have difficulty randomising high risk patients to artificialformulas where the risks are known, and where their own clinicalexperience suggests fewer complications when donor milk is used.Because these PTF are constantly changing, it could always be arguedthat to ensure scientific rigour, RCTswould need be repeated regularlyto evaluate potential improvements.

We suggest that it time to accept the evidence of potential andreasonable clinical benefit of donor human milk for preterm and illhospitalised infants. The evidence to date carries enough weight toencourage the establishment human milk banks where they aremanaged to an appropriate standard. We also propose that it is theresponsibility of these donor human milk banks and the neonatalunits to which they provide product, to engage in research to betterassess potential benefits of donor human milk and improve theproducts provided by human milk banks.

2. What we know about the benefits of PDHM

For preterm infants, PDHM reduces the incidence of NEC four-foldand improves feed tolerance [6,7]. This may be associated withreduced days of parenteral nutrition and earlier discharge fromhospital. Pasteurisation reduces the protective effects of HM butfeeding PDHM is associated with a lower incidence of infections thanfeeding formula [3]. It is also known that preterm infants fed PDHMgrow less well than those fed MOM [5,7] but the significance of this isunclear. It is unknown whether the high IQ scores associated withfeeding MOM to preterm infants [8,9] relates equally to PDHM.

For term infants, there is very limited evidence for benefit. HIVnegative infants, of HIV positive mothers, fed PDHM had, in general, alarger thymus than infants of healthy mothers fed formula interpretedby the investigators as indicating a benefit due to immune-modulationfactors in breastmilk [10]. PDHM has been used successfully to treatshort gut syndrome [11]. There is no evidence to support the higher IQwith breastfeeding of term infants [12,13] relate also to PDHM. There isno evidence that breastfeeding or feeding PDHM is useful in theprevention or treatment of CMP allergy [14,15].

Breastfeeding is one of the few preventative measures for reducingchildhood obesity rates [16] and this may be due to the lower proteincontent of HM [17]. There is little data on the body composition ofinfants fed PDHM although there are theoretical reasons for apotential benefit of feeding PDHM instead of formula in reducingchildhood obesity.

It has been suggested that feeding PDHM improves quality of lifefor paediatric and adult patients with cancer [18], short gut syndrome,post-surgical feeding problems and numerous other conditions basedlargely on anecdotal evidence [19].

We conclude that there is some evidence of benefit for preterminfants (reduced NEC risk, decreased sepsis and neuro-development)and therefore, these patients should remain the focus of donor humanmilk banking. We are concerned that making donor milk available tooutpatients or otherwise healthy term infants may result in donormilk becoming another alternative to mothers feeding their owninfants. Conclusive RCT evidence in support of PDHM use in preterminfants seems unlikely and focusing on collecting other physiologicalmeasures—for example ultrasound to assess gastric physiology, maybe a better use of resources.

3. The safety of HMB—management and regulation

Many countries continue to struggle to maintain the credibilityand confidence of clinicians in milk banking safety and efficacy due tothe lack of a regulatory body governing the operation of human milkbanks [20]. In countries such as Brazil, where governments havespecific legislation regulatingmilk banking these difficulties appear tobe significantly reduced [21]. During the establishment of the firstHMB in Australia we encountered barriers as existing legislation didnot recognise human milk as a Therapeutic Good or Food [22]. Thus,the two bodies regulating the production of these products, the TGA(Therapeutic Goods Administration) and FSANZ (Food StandardsAustralia New Zealand) did not have a legal framework to regulateHMB. As part of the current Australian government's response to the‘Best Start Report’ [23], independent consultants are reviewing thedevelopment of an Australian National Breastfeeding Strategy. Thescope of this consultancy also covers the potential development of aregulatory policy for human milk banking in Australia. This is aprocess endorsed and supported by the PREM Bank, in the interest ofencouraging the re-establishment of human milk banking in Australiain an evidence-based context ensuring the most appropriate qualitystandards are met by new milk banks.

HMB should be managed and regulated in such a way as to ensurethat appropriate measures are undertaken to allow response tounforseen risks. In the mid 1980s when HIV was identified in humanmilk, many HMB (all in Australia) closed. In Australia, HMB manage-ment at that time did not allow a rapid response to this unforseen risk.The informality of the screening process and the lack of complete recordkeeping, donation traceability and document and process control wereinsufficient to respond to this new threat. Since the emergence of thesenewdiseases, similar industries have developedmanagement strategiesto allowpublic confidence in the safetyof these valuable services. Blood/tissue banking and the food industry have risk management tools (e.g.Australian Code of Good Manufacturing Practices—Blood and Tissuesand Codex HACCP (Hazard Analysis Critical Control Points) require-ments) that are easily adapted for use during human milk bankmanagement. Although there is no formal regulation in Australia as yet,the PREMBankhas been established on these principles and encouragesregulation of the industry.

4. The safety of HMB—processing of donors and donations

In general, most milk banking countries commit to screening milkdonors for the same blood-borne viruses as required by blood banks.

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Rationalisation in some centres has led to dropping of screening forHTLV and restriction of hepatitis B screening to surface antigen.

In Australia, women who have lived for 6 months or more in theUK between 1980 and 1996 are excluded as breastmilk or blooddonors because of the risk of transmission of variant Creutzfeld-JakobDisease. While countries immediately affected by the Bovine Spongi-form Ecephalopathy (BSE) epidemic continue to operate human milkbanks without evidence of harm.

Other reasons for exclusion of donors include an assessment of anymedications or pharmacologically active herbal products a donormother may be taking that may be transferred to her breastmilk.Much is known about the transfer of common medications intobreastmilk and exclusion of donors based on maternal drugs is rarelynecessary but proceeds on a case by case basis [24–26].

Bacterial cultures ofmilk are not consistently performed in all HMBsand the bacterial count limits for rejectingmilk vary betweenHMBs andfrom that recommended [27]. In Australia, andmost countries, neonatalunits do not routinely culture or pasteurise MOM. The risks of feedingheavily contaminated MOM to very preterm infants is unknown, as arethe risks of feeding sterile PDHMor sterile ready-to-feed formula on thedevelopment of the preterm immune system.

From the past three years of operating the PREMBank, we do knowthat rigorous bacterial screening of donor milk pre and postpasteurisation will result in approximately 30% pasteurised milkbeing discarded. This rigorous bacterial screening regime has shownthat bacterial content of donated milk varies greatly between donorsand even between individual donations by the same donor. Most ofthe donormilk cultured and pasteurised, and on occasion discarded as‘unsafe’ by the PREM Bank, has been donated by other mothers ofpreterm infants in our unit and, as such, has been fed raw to their owninfant apparently without incident.

The PREM Bank has processed over 1400 batches of donor milksince establishment in 2006. Every batch has been cultured before andafter pasteurisation and, of these, only 36 showed bacterial growthpost pasteurisation. This is usually low colony counts of coagulasenegative staphylococcus but very occasionally high growth of Bacilluscereus, a known food-borne pathogen. This growth obviouslyprecludes their use and these batches are discarded. The germinationof the vegetative spores of B. cereus is a well-documented conse-quence of heat treatment during food production [28,29]. Only 5 ofthe 36 batches showed growth greater than 105cfu/ml in the pre-sample. Of the remaining 31 samples that had showed low (less than105cfu/ml) growth in the pre-sample only 16 would have beenrejected on the basis of the pre-sample containing potential patho-gens (using current but strict interpretation of UKAMB's bacterialscreening guideline endorsed by the PREM Bank). This suggests thatwithout routine post pasteurisation culture, one batch showinggrowth of a known food-borne pathogen would be released every100 batches processed. At the PREM Bank this would occur once every5 weeks of processing.

Currently there is little evidence of the risks associated with feedingheat-treated HM to preterm infants that had contained bacteriapotentially capable of producing heat stable enterotoxins [30]. However,due to the theoretical risk of this occurrence, manymilk banks choose toimplement strict screening standards. In the case of the PREM Bank thisdecision was driven by the risk assessment required during hazardanalysis critical control point (HACCP) development. Although currentevidence would suggest a low likelihood of bacteria that had beenpresent in donormilk prior to pasteurisation causing a clinical issue for arecipient of donor milk, the extreme vulnerability of our recipients,currently dictate this cautious approach to bacterial screening. To ensurethe viability of humanmilk banking and its ability to operate in themostefficient manner possible, revision of bacterial screening of milk isidentified as a major area requiring further research. The PREM Bank iscurrentlydeveloping real-timepolymerase chain reactionmethod for thespecific and rapid detection and quantification of bacteria and pathogens

inHMtoallowmilkwhich is heavily contaminatedor contains pathogensto be identified and discarded prior to pasteurisation.

Alternative approaches are used internationally to increaseefficiency and reduce cost while maintaining acceptable safety. Insome countries, milk is streamed to be fed raw or pasteurised to verypreterm and term infants based on level of contamination and risk topatient. For example, in Germany, donor milk with <103cfu/ml isused for feeding infants <1500 g either raw or pasteurised whereasmilk containing 104–105cfu/ml is analysed for pathogens andpasteurised for feeding older babies if pathogens <104cfu/ml [31].This appears to be a pragmatic approach to minimise the waste ofdonations but in the context of evidence-based practice it may bedifficult to implement in some countries.

Most HMB pasteurise donor milk at 62.5 °C for 30 min to eliminatebacteria and viruses. However, raw milk is used for preterm infants insome countries: raw donor milk has been used for many years inNorway for feeding preterm infants where donors are screened forHIV, hepatitis B & C, HTLV 1 & 2, and CMV and the milk screened toensure that it is free of pathogens and has low bacterial counts [32]; inSweden, raw donor milk is used in five of the 27 HMB for preterminfants [27].

In 1980, Bjorksten [30] demonstrated that pasteurisation reducedthe bioactivity of breastmilk. In our HMB, the retention of IgA,lactoferrin and lysozyme after classical pasteurisation at 62.5 °C was72.3+/−3.6%, 21.8+/−3.3% and 39.4+/−11.5%, n=22 [33]. It ispossible to optimise the pasteurisation temperature and improvepasteurisation design to improve the quality of PDHM, for example,pasteurisation at 57°C for 30 min retains 90% bioactivity and removes99.9% of bacteria [33].

Bile salt stimulated lipase is also inactivated by classical pasteur-isation, which will also remove the filaments from the humanmilk fatglobule [34]. These factors contribute to reduced fat absorption fromPDHM v raw milk [35,36]. Homogenisation of milk will improve fatabsorption [37] and should be used in HMB before milk is released topreterm patients.

Alternative technologies are being assessed aimed at preservingbioactivity while ensuring safety of donor milk. Studies usingultrasonic processing of bovine milk and orange juice suggest thismethod may be potentially useful for pasteurisation and homogeni-sation of human milk [38].

5. Nutritional adequacy and variability of PDHM

The composition of donor milk is highly variable with mean (co-efficient of variation) values for fate, protein and lactose being 4.16(21.54%) g/100 ml, 1.35 (24.52%)g/100 ml and 6.71 (8.93%)g/100 mlrespectively (n=50, PREM Bank). All very preterm infants being fedPDHM (and MOM) are supplemented with HM fortifiers containingprotein, calories and minerals. PREM Bank measures the nutritionalcomposition of dispensed milk and the data is used for nutritionalaudits and occasionally, for individualised fortification. Standardisa-tion of nutritional product from HMB is possible but rarely practised[39].

6. Cost evaluation

There have been previous attempts to compare the cost ofoperating a HMB with the potential cost savings derived from thereduction in incidence of NEC in neonatal intensive care [40,41]. Incountries where the background rates of NEC are low and hospitalcosts differ it may be difficult to transpose these cost/benefit models.However, simple comparisons can be made. In the US, private not-for-profit milk banks charge US$3.00 per 30 ml of PDHM, this chargecovers the cost of donor screening, milk processing and transport. Thisequates to approximately AU$120 per litre of donor milk. Followingour NICU standard feeding regime for a hypothetical 24 week CGA

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infant fed exclusively donor milk we would expect to require 10l ofdonor milk until discharge. Thus we could attribute a cost of AU$1200to provide donor milk for this hypothetical infant. This cost equates toless than a single day's care in our NICU. Given that many of thecomplications attributed to artificial formula use may increase thecomplexity of care and length of stay, providing PDHM needs only toprevent a few of these complications to recoup the investment manytimes over.

7. The way forward

HMB are most successful when developed as part of a package topromote breastfeeding and this is likely to provide the way forwardfor the further development and regulation of HMB in Australia. Theestablishment of the PREM Bank was only possible because ofgenerous financial contributions from the community and, unsoliciteddonations of breastmilk. The ongoing costs are incorporated into thebudgets of the neonatal intensive care unit and pathology departmentof our hospital, the only tertiary perinatal centre in WA. Thegovernment has commended the contribution of PREM Bank to thehealth of the community by presenting prestigious State and HealthDepartment awards in our first few years of operation.

Networks of HMB have been established in countries such as Braziland Sweden with some coordination of activities. In our region of theworld, PREM Bank is supporting the development of milk banks inMelbourne, Sydney, Brisbane, New Zealand and the Philippines (withUNICEF). Networks facilitate quality control and training, encouragecollaboration and contribute to maintaining standards and reducingcosts.

A reference laboratory within each region or country couldmonitor compliance with safety guidelines, liaise with Governmentand coordinate educational activities. We have become the referencelaboratory for our region and the lessons that we have learnt and theprotocols that we have developed are readily transmissible to otherunits.

Collaboration between HMB and between networks will lead todata collections and clinical studies which will provide evidence forrefining and improving the process of human milk banking andultimately clinical outcomes related to feeding preterm and sickinfants.

Acknowledgement

Perron Charitable Trusts, Telethon, Women's and Infants' Re-search Foundation, Raine Foundation, Ms. D Chiffings, Dr. T Keil, Prof.P Hartmann.

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