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ABM position statement

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Donor Milk Banks: protecting the health of preterm and sick babies
19 June marks the start of Scotland's National Breastfeeding Celebration Week (NBCW) 2017. The theme is changing the conversation around breastfeeding and culture. In this guest blog, Debbie Barnett, Donor Milk Bank Coordinator and Neonatal Infant Feeding Advisor at Queen Elizabeth University Hospital gives us a UK perspective on donor milk banks and the importance of changing perceptions of donor milk for the UK's most vulnerable babies.
Much has been written about the benefits of donor breast milk for preterm and sick babies where maternal milk is unavailable. Donor milk banks offer screened pasteurised donor milk, a safe alternative to formula as recommended by the World Health Organisation, European Society for Paediatric Gastroenterology, Hepatology and Nutrition and the American Academy of Paediatrics.

Donor Milk Banks: A UK Perspective

The UK Association of Milk Banks (UKAMB) is a registered charity set up in 1977 to support milk banking in the UK. UKAMB has supported NICE to produce guidelines for the safe operation of milk banks and continues to work with milk banks to implement best practice, providing education and support for milk bank staff and the wider public. UKAMB also represents milk banking at conferences, symposiums and on parliamentary working groups.

UKAMB currently has 16 milk banks registered on its website:

One in Scotland, a nationwide service covering all 14 territorial health boards

One in Ireland, working as regional service funded by the five legacy trusts in the North and billed per litre in the South

14 in England mainly operated and funded by local trusts.

Currently Wales has no territorial milk bank and the 14 milk banks in England vary in size and efficiency with no consistent approach to the provision of donor milk across the country. The largest milk bank in England works on a not-for-profit basis and the costs charged cover all aspects of the operation ensuring future sustainability. It uses a hub and spoke approach to cover large areas which otherwise may not have access to human milk. A new eagerly awaited milk bank will start operations very shortly as a not-for-profit enterprise with an eye on becoming a biobank to support breast cancer and other wider research. It hopes to cover London and the south east.

Why do we still have variable and inequitable access to donor milk across the UK?

A recent framework document published by the British Association of Perinatal Medicine,
The Use of Donor Human Expressed Breast Milk in Newborn Infants, points to some of the key reasons for this:

Differing opinions amongst health professionals of the benefit of donor milk

Milk banks vary in size and output with no nationally coordinated service

Need for better evidence to show clinical effect and cost-effectiveness of provision of donor milk.

Whilst there is an undeniable body of evidence supporting the wonders of mothers' own milk, when this is not available donor milk is widely regarded as the next best option. There is a need, however, for the development of further research to fully understand the clinical effect of donor milk, particularly the impact of the pasteurisation process used to make donor milk safe. That being said, it is widely recognised that donor milk helps to protect the health of vulnerable babies; for example, it can reduce the incidence of Necrotising Enterocolitis (NEC) in preterm babies, a devastating gut condition which can have lifelong and costly health consequences.

To support continued research into these benefits of donor milk, we need efficient, cost-effective milk banks which are able to meet the recommendations of the NICE guidelines. In addition, milk banks are seen as pivotal to promoting, protecting and supporting breastfeeding: the provision of donor milk does not exist in isolation of breastfeeding and breastfeeding support. We recognise that breastfeeding is now the collective societal responsibility; should the provision of donor milk to the most vulnerable infants in the UK be less of a responsibility?

Why donor milk matters

Louise always knew her pregnancy would be high risk as she had a heart condition, cardiomyopathy, a disease affecting the heart muscle. At 23 weeks into her pregnancy she went into heart failure and at 29 weeks the decision was made to deliver her baby by caesarean section after he had stopped growing. So five days later, after a course of steroids injections for mum to help prepare the baby's lungs, Ethan was born by caesarean section weighing just over 1kg. He was ventilated and stabilised, shown to mum and then prepared for transfer to the local NICU. Louise had always known that there was a chance that Ethan would be born prematurely and had made the decision that she would like donor milk to be his first food until she was able to provide her own milk.

Louise spent six days separated from her baby due to her own ill health and despite support never managed to get a milk supply established, only ever producing around 50mls a day though she continued to express for 18 weeks. Ethan was fed donor milk for the first six weeks of his life. Louise says, "during his time in NICU he had several infections requiring antibiotics and it was at these times I was most thankful for the donor milk; I am convinced it helped protect him against more serious gut infections."

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Donor Milk Banks: protecting the health of preterm and sick babies - Baby Friendly Initiative

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19 June marks the start of Scotland's National Breastfeeding Celebration Week (NBCW) 2017. The theme is changing the conversation around breastfeeding and culture. In this guest blog, Debbie Barnett, Donor Milk Bank Coordinator and Neonatal Infant Feeding Advisor at Queen Elizabeth University Hospital gives us a UK perspective on donor milk banks and the importance of changing perceptions of donor milk for the UK's most vulnerable babies.

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BabyCentre has been a certified member of The Information Standard since May 2015. The Information Standard is a certification programme, run by NHS England, for organisations producing health and care information. Each organisation is rigorously assessed to ensure that the information they provide is of the highest quality.

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Some mums make very generous amounts of milk, and this can be uncomfortable for them and for their babies. You might suspect breastfeeding over-supply if:

your baby gains weight very rapidly,

your baby sometimes splutters and gasps during feeds,

your baby is in discomfort after feeds and/or

y our breasts always feel full and you are troubled by frequent leaking.

Some mums with over-supply notice their babies seem to have explosive, frequent stools, often green in colour (though green poo can be normal, and in itself is not a cause for concern).

If you think your baby's discomfort, and possibly your own, are related to over-supply, talk about it with a breastfeeding counsellor or your midwife or health visitor. Having a feed observed by one of them is very helpful, too.

Babies can be fussy and uncomfortable for other reasons, such as difficulty transferring milk or a tongue tie. Sometimes, babies just take a little while to settle down, as does your milk production.

What can you do?

Over-supply usually settles down in time, but you can take steps to manage it better. If you are currently offering both breasts at each feed, it may be enough to just offer one breast per feed. If this does not work it is possible to reduce your production by block feeding - though this should only be done once you are sure your baby is thriving and growing well over a period of a few weeks.

Block feeding means using one breast only each time your baby comes to the breast, within a period of three/four/five or even more hours. You don't use your other breast during this time.

The 'unused breast' may fill and be uncomfortable during this time. It's important you're careful, and watch for blocked ducts or the development of mastitis, and perhaps gently express a little milk to ease the discomfort - don't express more than you have to, otherwise you will be stimulating more production.

How does it work?

Block feeding does not mean preventing your baby from taking the milk they want. Your baby stays on one breast for longer than usual, while the other, unused side remains full, sending a 'message' to your body to make less milk.

Block feeding can be effective within a few days, though for some very generous producers, the blocks need to extend to more hours before they really work.

There are other ways of coping with over supply. Not much research has gone into this aspect of breastfeeding, so these suggestions are based on what some mums have found helpful. You could try:

Adjusting the position of your baby, so they cope with the fast flow better (a more upright hold seems to help).

Fully expressing both breasts and getting out as much milk as you can. This seems to be effective if done once or twice, and it seems to recalibrate the production.

Gently hand expressing a little milk off, before putting your baby on the breast. This reduces the impact of the first let down, which can sometimes be quite strong, and overwhelm a baby.

You might also consider donating or sharing your excess milk (see below).

If you would like to explore any of these options, you can call an NCT breastfeeding counsellor on 0300 330 0700 who can help you find out more.

What is a milk bank?

A milk bank is a service which collects, screens, processes and then dispenses donated breastmilk to vulnerable babies. Donating to a milk bank is a good option if you are experiencing high production or oversupply. There are currently 17 milk banks in maternity units across the UK. Each one is a member of the United Kingdom Association for Milk Banking (UKAMB). This ensures that the donations are collected and stored to the highest standard.

Who can donate milk to a milk bank?

Any mum with an excess supply of breastmilk is welcome to donate breastmilk. She will, however, first be screened thoroughly for information on her lifestyle, previous medical history and infections. This is necessary as extra care needs to be taken with tiny and sick babies who are extremely vulnerable to the slightest infection or trace of medication in the breast milk.

How is the milk collected?

The milk bank will provide the donor with sterilised collection bottles and labels. After expressing it, the donor will then freeze it. The amount that is donated will be collected and transported to the milk bank, where it will then be processed separately and pasturised to kill any bacteria. Finally, it will be delivered to where it is needed most.

Who does the milk go to?

One in nine babies is born prematurely or sick and will have to spend time in a special care unit. These babies are very vulnerable to infection. Easier to digest and containing active enzymes that enhance the maturation of an underdeveloped gut, breastmilk is recognised as the optimum food for these vulnerable infants.

If the baby's mum cannot express her own for any reason (there may be a delay in her starting to produce it, perhaps they are too poorly to breastfeed) then donor breastmilk is the best alternative.

Other beneficiaries of breastmilk could include babies recovering from gut surgery, babies with allergies or babies with unusual gut syndromes making it difficult to absorb normal food.

How do I find a milk bank?

If you would like to become a donor, then you can contact your local milk back.

Donor milk is a very precious resource, and even the smallest amount will bring benefits to a sick or vulnerable baby.

What is milk sharing?

This differs from a milk bank as it is a private arrangement between two mums. This can be done between friends, sisters, or people who make contact via groups on the internet that help put women in touch with one another. These associations supply information to help you decide if this is something you would like to become part of.

There are some risks in milk sharing, which are greatly reduced if you know the person and can judge if (for example) their milk will be free of medication or other substances, and collected hygienically. If you would like to explore the options, you can call an NCT breastfeeding counsellor who can help you find out more.
Last updated: August 2016
Further information

NCT supports all parents, however they feed their baby. If you have questions, concerns or need support, you can speak to a breastfeeding counsellor by calling our helpline on 0300 330 0700, whether you are exclusively breastfeeding or using formula milk. Breastfeeding counsellors have had extensive training, will listen without judging or criticising and will offer relevant information and suggestions. You can also find more useful articles here.

National Breastfeeding Line (government funded): 0300 100 0212.

NHS information on mastitis.

Best Beginnings - Bump to Breastfeeding DVD Chapter 7 'Overcoming Challenges'.

Healthtalkonline.org: Managing Breastfeeding - dealing with difficult times.

The United Kingdom Association for Milk Banking (UKAMB) provides information on banks in the UK.

You might find Unicef's document on the benefits of donors useful.

Read the NICE booklet on Milk Banks

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Breastfeeding: oversupply of breast milk

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Some mums make very generous amounts of milk, and this can be uncomfortable for them and for their babies. You might suspect breastfeeding over-supply if: your baby gains weight very rapidly, your baby sometimes splutters and gasps during feeds, your baby is in discomfort after feeds and/or y our breasts always feel full and you are troubled by frequent leaking.

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Breastmilk Donation
Maternal breastmilk is the best nutrition for a baby who is ill, or born prematurely. However, mothers of sick children can often struggle to express any or enough of their own milk in the first few days after birth. In this situation, donated breastmilk is recommended by the WHO ¹, the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and the American Association of Pediatrics as the best alternative to maternal milk. It is the role of a milk bank to recruit and screen donors, check and process the milk, and store and distribute it to neonatal units safely.

Milk banks have existed in the UK for over 80 years. Before the 1980s there was a milk bank in almost ever maternity unit in the country. The combined effects of HIV, a greater emphasis on screening and safety incurring larger costs, and the increased use of formula by medical professionals led to the closure of the majority of milk banks. Now there are just 13 in England, none in Wales, a single milk bank in Northern Ireland which supplies most of the island of Ireland, and a National Service in Scotland.

Even after donated breastmilk is pasteurised (heat-treated for 30 mins at 62.5°C), 60% of immunoglobulins, and other components that help protect premature babies from infection and are not present in formula, are preserved. Work is ongoing to understand how heat treatment can affect other components, and whether other approaches to processing the milk may be better.

The WHO recommendation described above is relevant for healthcare settings where safe and affordable milk-banking facilities are available or can be set up. It does not address sick low birth weight infants or infants with birth weight less than 1.0 kg.

The current main recipients of donor breastmilk are preterm babies and babies recovering from gut surgery. Donor breastmilk may have a protective role against necrotising enterocolitis (NEC), which mainly affects premature babies ². The preterm immature gut is able to digest and absorb breastmilk more easily than formula milk. Other situations arise where donor breastmilk might be the preferred option for the parents when medical reasons prevent maternal breastmilk feeding (eg. maternal chemotherapy, essential maternal drugs contraindicated in breastfeeding). Currently donor milk quantities in the UK do not permit the regular use of donor milk in these circumstances and a case-by-case approach is necessary. The charity UKAMB is working towards the formation of a national donor breastmilk service to supply infants throughout the UK according to priority of need, rather than geographic proximity to a Milk Bank.
Breastmilk Donors
As the recipients of donor milk are often very premature or very sick babies, they are likely to have a compromised immune system, immature or damaged livers and kidneys or be more likely to be affected by contaminants in breastmilk. Milk banks have a duty to provide the safest breastmilk possible. For this reason they endeavour to screen out mothers whose milk may contain any metabolites from the breakdown of medications and drugs, (including nicotine, substances of abuse and alcohol) and other possible contaminants.

In all instances it is well recognized that although a mother may not be able to donate her breastmilk to a milk bank, that does not mean that her milk is unsafe for her own baby or that it would be better to use an artificial milk/formula. There are a very few situations where a mother may be advised by her GP or specialist not to breastfeed- these include cancer treatments, a few long term medications and if she has HIV. Courses of medications are sometimes given as a reason to temporarily stop breastfeeding but in most cases it is safe to continue to do so (see our webpages on ' Prescribing Information ' to check for specialist information on the safety of drugs in Breastmilk).

All potential milk donors must have up to date screening for the following blood borne viruses and cannot donate if they test positive (see NICE Guideline CG93 below):
With thanks to both Dr Shenker and Gillian Weaver for their contributions to this website. They are the co-founders of the Hearts Milk Bank, the UK's newest milk bank, which will provide donor milk across London and the South East and support programmes of research into breast cancer risk, infant nutrition and the optimal processing and use of donated breastmilk. Further Information
UKAMB: Information for Professionals Information about the latest protocols, evidence underpinning donor milk use and milk bank operations.

United Kingdom Association for Milk Banking (UKAMB) Charity that supports human milk banking in the UK, good practice and guideline development. The website includes a map of UK Donor Milk Banks.

One Milk Bank for Scotland Milk bank hosted by NHS Greater Glasgow and Clyde covering the whole of Scotland.

The Western Trust Milk Bank Issues donor milk to units around Ireland, operating in accordance with UK NICE guidance.

Hearts Milk Bank The UK's newest milk bank, which will provide donor milk across London and the South East and support a new programme of breast cancer research.

UKAMB: Breastmilk Sharing Statement Advice on safe milk donation.

NICE Guidance CG93: Donor milk banks - Service Operation (2010) Includes guidance on screening and selecting donors, expressing and handling breastmilk at home for donation.
References

1. WHO: Donor Human Milk for Low Birth Weight Infants Updated January 2017

2. Boyd C, Quigley M, Brocklehurst P. Donor breast milk versus infant formula for preterm infants: systematic review and meta-analysis. Archives of Disease in Childhood - Fetal and Neonatal Edition. 2007;92(3):F169-F175.

Published April 2017

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by Dr Natalie Shenker, BM BCh (Oxon), MSc, PhD Epigenetics and Breast Cancer (Imperial) Breastmilk Donation Maternal breastmilk is the best nutrition for a baby who is ill, or born prematurely. However, mothers of sick children can often struggle to express any or enough of their own milk in the first few days after birth.

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TV sports presenter Amanda Davies had enjoyed an uncomplicated pregnancy - but it became a slowly unfolding nightmare when, alarmingly, two months before her due date her waters broke while she was live on air.

'It was the BBC World sports shift, which is notoriously quiet,' says the daughter of former Football Association chief executive David Davies. 'I had not felt right for days but couldn't put my finger on it. A friend who was six weeks ahead of me in pregnancy had said it was normal to feel a little damp, but I started to Google my symptoms, which was probably a terrible idea,' says the 33-year-old, who has just moved from the BBC to CNN.

During pregnancy, a sac filled with a liquid known as amniotic fluid surrounds the growing foetus. Towards the end of gestation, the amount of collagen, a tough fibrous protein, decreases in the chorion, the outer layer of the sac. As the collagen decreases, the bag of waters will break.

For the majority of women, this will occur spontaneously during labour. However, in about eight to ten per cent of women who deliver early, the waters will break before the onset of labour (premature rupture of membranes) and this can also happen partially.

'It's known as a hind water leak,' says consultant obstetrician and gynaecologist Clive Spence Jones. 'It means that a small hole appears somewhere in the sac, away from the cervix. We don't really know why it happens, but a lot of research is being done on the subject. Often these women can go on for days or weeks before delivering.'

Amanda says: 'Some mothers online referred to this as "having sprung a leak". I decided, to be on the safe side, to call the hospital. They said I should come in, so once I had finished my shift I turned up in full studio make-up, expecting to be sent home. But, after I was examined, the doctors decided to admit me for monitoring, explaining that my baby could be born early.

'Sam, my husband, was working in Cyprus, so I called him - I wasn't worried or upset at that point, and he didn't come back for another two days.'

For seven days, nothing happened. Then, on May 25, 2009, Amanda went into labour.

'At first I was relaxed, or as relaxed as you can be when you're having a baby nine weeks early. We'd had time to prepare ourselves for what was going to happen. I'd been taking hypno-birthing classes and was planning on no pain relief. I had my music playing.

'Then, a few hours in, the baby's heart rate dropped and suddenly the doctors rushed in and told me they had to get her out straight away. There was no time for pain relief and I don't remember anything but a feeling of panic.'

The obstetrician performed an episiotomy and forceps delivery - the baby weighed just 3 lb 10oz and wasn't breathing. Amanda says: 'The cord was wrapped around her neck, and when we caught a glimpse of her through the crowd of doctors and nurses she looked as if she'd gone ten rounds with Mike Tyson.

'I was terrified. My husband and I were speechless - it's not how you envisage seeing your newborn baby. People kept telling us, "It's going to be OK," but it's hard to believe.

'You just have to trust they are doing everything they can. And then, about five minutes after I'd given birth, a doctor said I needed emergency treatment.'

After baby Molly was successfully resuscitated, she was taken to neonatal intensive care, where she remained for six weeks.

Amanda was cared for in the adult intensive care ward after suffering from heavy bleeding.

'It was before I was wheeled away that a paediatric doctor asked if I would like Molly to receive breast milk, that they had a milk bank and that it was what they recommended,' she says. 'It hadn't crossed my mind - in the whole build-up to having a premature baby, you don't think about how you are going to feed it. We asked if there were any risks and they said no. So we agreed.'

Research has shown that breast milk is the best nourishment for babies and that it is highly beneficial to their health in the short, medium and long-term, particularly for sick or premature infants.

The Department of Health recommends women breastfeed exclusively for six months and continue after that as part of a balanced diet.

Breast milk contains a complete spectrum of nutrients, alongside hormones and immune-system compounds which are not in formula milk. Giving premature babies breast milk protects them against infections and helps development, and they are much less likely to develop a common, life-threatening gut infection called necrotising enterocolitis.

The process that leads to natural milk production begins when a baby is born, but if labour is premature it can take three to four days before a woman is able to make enough. This can be longer if the birth is very early, or the mother is unwell.

Many neonatal units recommend donor milk be offered in cases where women either can't feed due to illness, as in Amanda's case, or for those who give birth prematurely and are not yet producing their own breast milk. Milk banking at Queen Charlotte's & Chelsea Hospital, London, where by chance Amanda gave birth, was initiated in the Thirties by a matron to help provide breast milk to a woman who had delivered quads and couldn't keep up with the demands of her four hungry babies.

Today, new mothers can choose to donate their breast milk to a dedicated milk bank - there are 18 in the UK. Donors are mothers who are making more than their baby needs, expressing the milk and would otherwise be throwing it away.

Volunteers are screened for diseases, the milk is tested and heat-treated to remove harmful bacteria or viruses, and then frozen so it can be used on request. Unlike some blood products, milk is not pooled and babies will often receive milk from only one donor. The process is confidential, but banks keep records of donors and who their milk goes to.

Milk bank manager Gillian Weaver has worked at the Queen Charlotte for more than 20 years. She says: 'Most babies will need donor milk for only a few days while the mother establishes her own supply, but in cases where the mother is ill this can take longer. The nutritional value of the milk is affected slightly by the heat processing, but it has to be done that way for safety reasons. Supply is not usually a problem, although we always need donors.'

However, advocates claim there is a lack of awareness, principally among obstetricians and midwives - and concerns about HIV and other diseases transmittable via breast milk meant breastfeeding fell out of favour in the Eighties. In answer to this, NICE, the National Institute for Health and Clinical Excellence, has produced official safety guidance.

Amanda, who lives in West London with Sam, says: 'If you'd have told me about using a milk bank before I'd have thought it odd, but once you know it's no risk, then it makes perfect sense.

'My breast-milk production didn't start for a few weeks after I gave birth. I had always planned to breastfeed but giving birth prematurely, and being unwell myself, then living on coffee and cakes from the hospital cafe, while we tried to spend as much time as possible with our daughter in hospital, I suppose didn't help things. I tried eating steak and spinach, and drinking special teas. It was a struggle, and eventually it did come.

'By the time Molly came home I was breastfeeding her. I'm grateful she had breast milk during those first two weeks, as it gave her the best start healthwise. And it was a boost to me emotionally knowing that even though I couldn't feed her, Molly was getting the next best thing when she was at her most vulnerable.'

Gillian says: 'We are generally able to supply breast milk through our network with the help of bike couriers, even if a hospital is many miles away from its nearest bank.

'Usually, milk banks accept milk only from healthy mums who have babies under six months old who are not yet weaned on to solids. Extra care has to be taken when giving another mum's milk to premature or sick babies. Staff will want to know if you have a condition you take medicines for, including herbal medicines. Having a health condition or taking medicines won't necessarily rule you out.

'Donors also have their blood tested at the time of donating to screen for any diseases they might not know they have. Staff may also want to know if you drink more than two units of alcohol a day and how many caffeine-containing drinks you have. Milk banks cannot take milk from mothers who smoke, or have ever tested positive for a range of infectious diseases.'

Donor Carina Johnstone-Ayliffe, 28, a junior doctor, met Amanda at a recent donor event. She says: 'I started donating when my son Oliver began sleeping through the night at three months.

'I was expressing milk and it seemed a shame to waste it. When I heard about the milk bank, I thought what a wonderful way to help premature and sick babies.'

Molly, now nearly three, is healthy and thriving. Amanda was so indebted to the Queen Charlotte's milk bank that she has become its patron. She says: 'It's a fabulous resource providing breast milk, with its valuable nutrients and antibodies, to tiny and potentially very sick babies.'

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Saved by the breast milk bank: Sports presenter Amanda Davies believes it was a lifeline for her daughter Molly

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TV sports presenter Amanda Davies had enjoyed an uncomplicated pregnancy - but it became a slowly unfolding nightmare when, alarmingly, two months before her due date her waters broke while she was live on air. 'It was the BBC World sports shift, which is notoriously quiet,' says the daughter of former Football Association chief executive David Davies.

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Abstract

The number of human milk banks is increasing worldwide. Although the beneficial effects of feeding premature infants with their mother's milk are well documented, less is known about the effects of feeding these infants with pasteurized donor milk. We propose a randomized trial comparing the effects of a 100% human milk-based diet (human milk supplemented with a human milk-derived fortifier) and a diet (partially) based on bovine milk. In theory, human milk has a beneficial effect on various aspects of human physiology, most of which become apparent after infancy. We therefore propose an extensive follow-up program that takes this aspect into consideration. Other issues concerning the practice of human milk banks need to be addressed as well as optimization of the feeding strategies for preterm infants.

Keywords: premature neonate, formula, donor milk, donor screening, vertical transmission, human milk fortifier, outcome

1. Introduction

Worldwide human milk banks are re-emerging after closing in the mid-1980s due to the identification of human immunodeficiency virus (HIV) in breast milk. The aim of human milk banks is to provide safe donor milk to (premature) infants so that they can benefit from the advantages of human milk when their own mother is unable to provide milk. The benefits of feeding (premature) infants with fresh milk from their own mothers are well documented [ 1]. However, pasteurized donor milk does not necessarily exert the same positive effects as raw milk from the mother. The milk banking process (pasteurization, repetitive freeze-thawing and storage) partly inactivates the biological substances responsible for the beneficial effects, thereby diminishing the nutritional and protective value of human milk [ 2]. However, there are additional differences between donor milk and mother's own milk that have to be taken into consideration. For example, breast milk contains specific secretory immunoglobulins (sIgA) formed through the enteromammary pathway in reaction to pathogens from the environment. While a mother and her child usually share the same environment, this is not the case for the donor mother and the receiving infant. It can therefore be argued that the sIgA found in donor milk are not as well tailored to the infant's needs compared to those in the milk of the infant's own mother. This difference might be specifically important for children admitted to the Neonatal Intensive Care Unit (NICU) - an environment with unusual pathogens. Although a graft versus host reaction caused by leukocytes in raw donor milk has been proposed, there has been no evidence found supporting the existence of such a phenomenon [ 3]. Given that (preterm) formula is cheaper than processed donor milk and formula does not pose the (albeit theoretical) risk of vertical transmission of infection, proof of the benefit of human donor milk is needed.

2. Evidence of the Benefits of Donor Milk

Two meta-analyses have shown a reduction in the incidence of necrotizing enterocolitis (NEC) in low birth-weight infants that were fed donor milk compared to those fed with formula. However, the infants who were fed donor milk showed slower growth rates in comparison to infants who were fed (preterm) formula. Decreased growth rate is associated with neurodevelopmental impairment [ 4]. Interpretation of these results is hampered by the fact that pasteurized milk without fortification was given to the infants in seven of the eight studies analyzed [ 5], which is not a reflection of current practice. Milk from the mother is fortified with additional proteins, minerals and vitamins to meet the infant's requirements. Furthermore, there was a substantial heterogeneity between the studies, and none of them were blinded studies. Most included trials were performed in the late 1970s and early 1980s, while only one was performed after the year 2000. In a cohort study by Hylander et al. [ 6], consumption of mother's milk had a large effect on infectious morbidity. They found a 47% combined infection incidence in the formula group compared to 29% in the human milk group. In addition, in a randomized trial by Narayanan et al. [ 7], human milk consumption (both milk from the mother and pasteurized donor milk) reduced the incidence of infection. De Silva et al., however, did not find conclusive evidence of the protective effect of human milk on the development of late onset sepsis or other infections in their systematic review [ 8]. Valuable evidence regarding the effects of the different types of feeding for premature neonates was provided by Lucas and co-workers in two large parallel randomized controlled trials conducted in the United Kingdom in the early 1980s. In the first trial, infants were randomized between receiving donor milk or preterm formula (either as a sole diet or in addition to the mother's milk). The infants in the second trial were randomized between receiving preterm formula or term formula (either as a sole diet or in addition to the mother's milk). The results of the two trials were analyzed separately and combined. Infants were followed-up into adulthood, thereby providing information on the long-term effects of human milk feeding. At the corrected age of 18 months, infants were subjected to the Bayley scale of infant development to assess their mental development index (MDI) and psychomotor development index (PDI). Infants who were fed preterm formula (protein: 2.0 g, energy: 80 kcal/100 mL) showed a 6-point advantage in MDI scores and a 14.7-point advantage in PDI scores compared to infants who were fed term formula (protein: 1.45 g, energy: 68 kcal/100 mL) [ 9]. Interestingly, infants fed donor milk (protein: 1.1 g, energy: 50 kcal/100 mL) had similar outcomes compared to infants fed preterm formula, despite the low nutrient content of donor milk compared to the preterm formula and to the estimated needs of preterm infants [ 9]. Apparently, human milk contains an entity capable of making up for the low nutrient content. The same infants were also studied at 13-16 years of age to assess the influence of early diet on the development of cardiovascular risk factors. Infants who received banked human milk showed lower C-reactive protein (CRP) levels and LDL/HDL ratios [ 10] and a lower mean and diastolic blood pressure [ 11]. These studies suggest that, after premature birth, the type of nutrition in the first weeks of life influences the risk of developing cardiovascular disease in later life. Optimization of early nutrition will therefore have a major impact on future health of infants and seems to be a highly effective preventative measure.

3. Studies to be Undertaken

Conducting studies on the effects of donor milk in comparison to mother's milk or formula is complicated for various reasons. First, from an ethical point of view, it is not possible to randomize infants who receive their mother's milk between formula and donor milk. It is known that mothers from higher sociodemographic groups are more likely to breastfeed their infants [ 12]. Sociodemographic factors such as household income are known determinants of the development and physical health of children [ 13] and should therefore be considered confounders in research on the effects of breastfeeding. However, controlling for these confounders might not be sufficient. Secondly, the staff at hospitals where it is common practice to feed premature neonates with donor milk when their own mother's milk is unavailable considers it to be unethical to randomize infants between donor milk and preterm formula. This kind of research, therefore, needs to be conducted in hospitals in which donor milk is not the standard choice of nutrition for infants not receiving their own mother's milk. In our and most other hospitals, the majority of mothers delivering a very low birth-weight (VLBW) infant initially express breast milk, but a large proportion of them are unable to provide sufficient amounts of milk to feed their infant during the full admission period, especially not when their infant starts to need larger volumes of milk. These infants therefore receive a mixture of their own mother's milk and preterm formula or donor breast milk. Basically, two questions need to be answered: First, does donor milk have advantages over preterm formula as a sole diet? Second, does donor milk as a supplement to the mother's milk hold advantages over supplemental preterm formula? If so, is there a dose-dependent effect of human milk? To answer these questions, we propose the study design depicted in . Parameters such as growth rate and the incidence of infections in the different groups should be studied; however, many more aspects of the developing premature neonate are worth studying. Several important beneficial effects of human milk only become apparent after infancy. The follow-up of children included in these studies, therefore, needs to continue into adulthood. The different aspects of human physiology that can be influenced by early nutrition should be taken into account when performing follow-up studies. The possible fields include but are certainly not limited to the following: (1) immunity, allergy and gut health. Human milk is thought to have the ability to induce tolerance to allergens, while at the same time serving as a source of passive immunization and inducing a "healthy" gut flora. This induction would lead to a lower incidence of allergies and infections in later life; (2) neurocognitive development. Essential fatty acids present in human milk and the high taurine content could be responsible for the observed favorable neurodevelopmental outcome in infants fed with human milk. However, the underlying mechanisms need to be elucidated; (3) cardiovascular and metabolic consequences. Human milk seems to improve lipid profiles and lower blood pressure, leading to lower cardiovascular risk in later life; and (4) cost-effectiveness of human milk banking should not only be studied in relationship to the expenses made during admission to the NICU but should also be seen in the light of potential healthcare savings in later life.

Figure 1

4. Additional Issues to be Resolved

Some practical issues regarding the processing of human milk and feeding of premature neonates need to be addressed.

4.1. Method of Pasteurization

Given that viruses and other pathogens can be transmitted by the consumption of infected milk, most, but not all, human milk banks pasteurize donor milk prior to feeding it to (premature) infants. Holder pasteurization (heating at 62.5 °C for 30 minutes, HP) is the most frequently used method of pasteurization in human milk banks and is known to effectively eliminate viruses such as HIV [ 14], CMV [ 15] and most bacteria. However, this procedure has profound effects on the nutrients and immunological factors in human milk. New methods such as flash pasteurization (heating the milk to higher temperatures for a short time) seem promising with respect to eliminating pathogens while preserving valuable biological substances and nutrients [ 16]. More research needs to be performed to ensure the safety of this method and the optimal temperature and duration of the pasteurization process. Although high temperature-short time (HTST) pasteurizers are widely used in the dairy industry, none are tailored for use in human milk banks.

4.2. Safety of the Milk

Most human milk banks use the same selection and screening procedures for donor mothers that local blood banks use for selection and screening of blood donors. This seems to be an appropriate practice because breast milk is produced from blood. Nonetheless, it can be argued that procedures for the selection of milk donors should be adjusted on the basis of the properties of human lactation, the practice of milk banks and the vulnerability of the recipient population. In contrast to blood products, donor milk is pasteurized and is administered enterally. Some diseases transmissible by blood transfusion might not be of importance for the safety of human donor milk consumption, whereas others (known and unknown) might be highly transmissible by human milk. The potential risk of transmission of infectious agents through human (donor) milk is a rather unexplored field. One of the discussed screening criteria for blood donors concerns transmission of variant Creutzfeldt-Jakob (vCJD) disease. In The Netherlands, people who have lived in the UK for more than six months between 1980 and 1996 are excluded as blood donors, and maybe, they should be excluded as milk donors as well. However, in countries with a high incidence of bovine spongiform encephalopathy, no cases of vCJD transmitted through human milk have been reported. In addition, cow's milk is not included as a source of possible transmission of the disease [ 17], which makes this screening criteria for milk donation debatable as evidence for transmission of vCJD via human milk is also lacking.

On the other hand, other infectious agents that could be transmitted through human (donor) milk might be relevant. In the last few years there has been an outbreak of Coxiella burnetii (Q-fever) in The Netherlands. Q-fever is known to be transmitted by consumption of raw milk from infected cattle but is also thought to potentially be transmitted by blood transfusion. Recently, the Dutch blood banks began screening blood donors from endemic areas for this disease. Vertical transmission of Q-fever in utero, during delivery, or lactation, has been suggested [ 18]. Pasteurization (63 °C, 30 minutes) has been shown to eliminate C. burnetii effectively from cow's milk [ 19]. Whether pasteurized milk from an infected donor poses a risk to the premature newborn is unknown. Further research in this field is necessary.

4.3. Method of Fortification

Unfortunately, both mother's milk and donor milk lacks sufficient nutrients to meet the high metabolic demands of premature neonates. Human milk is therefore fortified by multinutrient supplements, comprising extra protein, fat, carbohydrate, vitamins and minerals. The nutritional needs of infants are usually met through this supplementation. However, as these fortifiers are derived from cow's milk, it can be hypothesized that these bovine fortifiers are a contributing factor in the development of NEC in preterm infants, as is seen in formula-fed neonates. Theoretically, the suggested protective effects of human milk might be overruled by the directly disrupting effect of cow milk proteins. A very recent study by Sullivan et al. [ 20] seems to confirm this hypothesis. In this study, a commercially available human milk-based fortifier (Prolact+ H 2 MF, Prolacta Bioscience, Monrovia, California) was used in a population with a very high background incidence of NEC. The results showed that infants receiving this fortifier in addition to their own mother's milk and donor milk had a significantly lower risk to die and/or develop NEC compared to infants fed with a bovine milk-based fortifier and preterm formula in addition to their own mother's milk. With the development of commercially available machines that perform techniques such as ultrafiltration and freeze-drying, it should become possible for human milk banks to produce a human milk-based fortifier. However, the financial costs of these processes are high, and the clinical benefits of a human milk-based fortifier still remain to be confirmed.

In conclusion, with the quality of human milk banking and of artificial formula constantly improving, it seems mandatory to continuously monitor the effects of our practices. Collaboration of human milk banks on research projects and other aspects (e.g., the production of a human milk-based fortifier) will contribute substantially to our knowledge of the optimal feeding strategy for premature neonates. The present feeding strategies do not meet the requirements when both safety and efficacy are considered. A fortified, exclusively human milk-based diet might solve this issue.

References

5. Quigley M.A., Henderson G., Anthony M.Y., McGuire W. Formula milk versus donor breast milk for feeding preterm or low birth weight infants. Cochrane Database Syst. Rev. 2007:CD002971. [ PubMed]

13. Victorino C.C., Gauthier A.H. The social determinants of child health: variations across health outcomes - a population-based cross-sectional analysis. BMC Pediatr. 2009;9:53. doi: 10.1186/1471-2431-9-53. [ PMC free article] [ PubMed] [ CrossRef]

19. Cerf O., Condron R. Coxiella burnetii and milk pasteurization: an early application of the precautionary principle? Epidemiol. Infect. 2006;134:946-951. doi: 10.1017/S0950268806005978. [ PMC free article] [ PubMed] [ CrossRef]

20. Sullivan S., Schanler R.J., Kim J.H., Patel A.L., Trawoger R., Kiechl-Kohlendorfer U., Chan G.M., Blanco C.L., Abrams S., Cotten C.M., Laroia N., Ehrenkranz R.A., Dudell G., Cristofalo E.A., Meier P., Lee M.L., Rechtman D.J., Lucas A. An Exclusively Human Milk-Based Diet Is Associated with a Lower Rate of Necrotizing Enterocolitis than a Diet of Human Milk and Bovine Milk-Based Products. J. Pediatr. 2010;156:562-567. doi: 10.1016/j.jpeds.2009.10.040. [ PubMed] [ CrossRef]

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Human Milk Banking-Facts and Issues to Resolve

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The number of human milk banks is increasing worldwide. Although the beneficial effects of feeding premature infants with their mother's milk are well documented, less is known about the effects of feeding these infants with pasteurized donor milk.

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Start collecting!

The milk bank will send you bottles to store and freeze your milk. If you already have a stock of milk in breastmilk bags, your milk bank may accept this, although the fat in the milk is not released from breastmilk bags as well as it is from milk bank bottles. Premature babies rely on high-fat milk to grow, and the bottles milk banks use are designed to increase the available fat as much as possible.

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The milk bank will send you bottles to store and freeze your milk. If you already have a stock of milk in breastmilk bags, your milk bank may accept this, although the fat in the milk is not released from breastmilk bags as well as it is from milk bank bottles.

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Donor milk banks: service operation | Guidance and guidelines | NICE

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Evidence-based recommendations on the operation of donor milk banks for staff who support mothers and carers of infants who receive, or women who donate..