Human milk is the preferred nutrition for preterm infants. (WHO/UNICEF, 2003) Human milk has been proven to be beneficial to reduce the risk of short term and long term complications related to prematurity.(Victora et al., 2016, Belfort and Ehrenkranz, 2017) Not all mothers are able to provide adequate breast milk to meet their babies requirement. Donor breast milk (DBM) can supplement maternal breastmilk when it is insufficient or as an alternative if the mother prefer not to initiate the process of lactation. Donor breast milk is defined as breast milk expressed by mother that is then processed by human milk bank for use by a recipient that is not the mother’s own baby. Studies have shown the benefit of provision of DBM compared to formula feeding in preterm infants including reduction in time to establish enteral feeds and risk of necrotising enterocolitis. (Quigley et al., 2019) The use of DBM has been linked to increase in rate of breastfeeding at time of discharge from neonatal unit. (Arslanoglu et al., 2013)
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Human milk banking began a century ago. The European Milk Bank Association (EMBA) was officially launched in October 2010 to promote human milk banking (HMB) and to encourage international co-operation between human milk bank. There are currently 225 HMBs operating in 28 countries in Europe. There are differences between national guidelines for using donor breast milk due to lack of evidence for some points related to the operation of human milk bank. Recommendations for establishment and operation of human milk banks in Europe was published by EMBA in 2019 due to lack of European-wide guidelines. (Weaver et al., 2019)
A robust quality assurance plan need to be in place to ensure the safe operation of human milk bank such as Hazard Analysis Quality Control Points (HACCP). (NICE, 2010) All the equipment used in donor milk handling and processing need to be validated, calibrated and maintained according to manufacturer’s instruction. They have to be checked and qualified annually to ensure conformity with recommendations. All the containers of human milk should always be labelled with donor’s name and unique ID and the date of expression. In addition, DBM should be labelled with the milk’s expiry date, whether the milk is raw or processed and if the milk is ready to use. Exposure to DBM to sunlight and/or phototherapy should be minimised at all time. All milk bank staff should undertake training by an experienced member of staff before engaging in an unsupervised work in HMB. Training should cover good practice and ensure that each staff member understands the regulatory, legal and ethical aspects of their work. DBM should be handled hygienically and staff member should wash their hands prior entering clean areas and handling DBM. Records of all donors should be kept including the volume of milk donated to ensure traceability. Measures should be taken to ensure optimum temperature is maintained for DBM during transport. DBM should not be placed directly in transport container. A clear polyethene bag can be used for easy identification of DBM for minimal handling. Transport boxes/bags should be decontaminated between batches of milk. (Weaver et al., 2019)
Donor Recruitment and Screening
The promotion of donation of breastmilk should be aimed to reach as many potential donors as possible through different channels including providing written information or direct referrals. (NICE, 2010) A clear, non-technical language should be used. Potential donors will need to undergo an interview process, referring to medical sources if necessary. The potential donors should be informed regarding the need for serological testing at the time of enrolment. Currently, there is no consensus on safe amounts of alcohol intake prior to expressing donor breast milk. Therefore, EMBA recommends that donor avoid alcohol and never donate milk expressed within 4 hours of moderate drinking. Other criteria which exclude potential donors includes
- Currently smoke or uses nicotine replacement therapy.
- Current or prior usage of recreational drugs
- Previously tested positive for HIV 1 or 2, hepatitis B or C, Human T-lymphotropic virus (HTLV) type I or II, or syphilis
- Increased risk of Creutzfeldt-Jakob disease (CJD)
Before accepting a donor’s milk, a written consent will be sought during enrolment for the processing and intended use of donated milk and for the purpose of approved research if relevant. Routine serological test will not be repeated while the donor is donating milk. All donors should informed human milk bank if there is any changes in health status.
Training and supporting donors
All donors will be provided with appropriate training and support throughout the donation process.The training should cover
- Hand washing and the importance of this
- Milk collection and expression, including cleaning and using breast pumps and containers
- Storage of donated milk (within 24 hours)
- Labelling donated milk, and documenting storage conditions
- Transportation of donated milk (if needed)
Expression, handling and storage of human milk for donation to the human milk bank
Donors should collect expressed milk rather than drip milk. Donor milk will be accepted if hand expressed, manual pump-expressed, and electric pump expressed milk. Raw and pasteurised human milk will be stored in a separate, clearly labelled refrigerators and freezer, or if not possible in separate clearly labelled fridge and freezer compartment. Pooling of DBM from same donor is acceptable prior to any heat processing.
Milk screening and treatment
There is no consensus for recommendations for microbiological testing of DHM either before or after pasteurisation. Within Europe, guidelines vary both in timing and frequency of testing and in the acceptance criteria both locally and national. The best practice suggests
- Before pasteurisation
- All pools of milk be tested prior to pasteurisation
- Each batch of milk be tested after pasteurisation
- Acceptance criteria: 105 cfu/ml or less of non-pathogenic organisms and no pathogens for each pool of milk tested prior to pasteurisation. All samples of milk from a pool that does not meet this standard shall be discarded
- After pasteurisation
- The batch will be discarded if any microbial growth detected in a random sample taken after pasteurisation
Current recommendation for heat treatment/pasteurisation temperature and time is 62.5°C for 30 minutes followed by rapid cooling to at least 10°C and preferably 4°C prior to transfer to a freezer. The process and temperature will be monitored throughout treatment.(Picaud and Buffin, 2017)
Supply of donor breast milk to Recipients
All donor breast milk will be labelled at each stage for traceability of the milk using barcode system. (ICCBBA, 2016) The receiving hospital should document how donor milk is used including in infant’s hospital notes. An informed consent should be acquired from recipient’s mother/parent/carer prior to administration of donor milk. DBM should never be defrost or warm using a microwave oven.
Studies has shown variability between protein and fat content of breast milk between samples from different mothers and also same mothers. The protein content in breast milk of mother delivering prematurely has been shown to be higher than of those mother delivering at term. However, this may be due to reduced total volume of milk. However, the differences diminishes over a period of few weeks. (Ballard and Morrow, 2013, Kreissl et al., 2016) The use of donor breast milk alone is insufficient to provide adequate nutritional intake for preterm infants and often would require additional supplementation.(Valentine et al., 2010) Preterm human milk contained significantly more fat and more calorific content in the first two weeks of lactation, while Term human milk revealed higher fat and calorie later during lactation (three to eight weeks). The fortification method relying on assumed human milk composition resulted in inadequate intake. Fischer Fumeaux et al has shown the actual median daily intakes of energy, protein and fat were significantly lower in fortified breast milk. (Fischer Fumeaux et al., 2019, Macedo et al., 2018) With ‘lacto-engineering’, DBM with highest nutritional content (protein and fat content) can be reserved for the most high risk baby (extremely low birth weight and extremely premature infants) to maximise their requirement. A targeted fortification can be used to maximise the nutrient to meet the infant requirement.
Human milk bank play an important role especially in preterm infants who are the most vulnerable population. The quality of human milk bank need to be audited yearly to ensure the highest standard of operation. With ‘lacto-engineering’, preterm infants would be able to receive adequate nutritional intake to reach optimum growth.
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- BALLARD, O. & MORROW, A. L. 2013. Human milk composition: nutrients and bioactive factors. Pediatric clinics of North America, 60, 49-74.
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- MACEDO, I., PEREIRA-DA-SILVA, L. & CARDOSO, M. 2018. The fortification method relying on assumed human milk composition overestimates the actual energy and macronutrient intakes in very preterm infants. Matern Health Neonatol Perinatol, 4, 22.
- NICE. 2010. NICE Clinical Guideline 93. Donor Milk Banks; Service Operation [Online]. Available: https://www.nice.org.uk/guidance/cg93 [Accessed 17 July 2019].
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- QUIGLEY, M., EMBLETON, N. D. & MCGUIRE, W. 2019. Formula versus donor breast milk for feeding preterm or low birth weight infants. Cochrane Database of Systematic Reviews.
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- VICTORA, C. G., BAHL, R., BARROS, A. J., FRANCA, G. V., HORTON, S., KRASEVEC, J., MURCH, S., SANKAR, M. J., WALKER, N. & ROLLINS, N. C. 2016. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet, 387, 475-90.
- WEAVER, G., BERTINO, E., GEBAUER, C., GROVSLIEN, A., MILEUSNIC-MILENOVIC, R., ARSLANOGLU, S., BARNETT, D., BOQUIEN, C.-Y., BUFFIN, R., GAYA, A., MORO, G. E., WESOLOWSKA, A. & PICAUD, J.-C. 2019. Recommendations for the Establishment and Operation of Human Milk Banks in Europe: A Consensus Statement From the European Milk Bank Association (EMBA). Frontiers in Pediatrics, 7.
- WHO/UNICEF. 2003. Global Strategy for Infant and Young Child Feeding. WHO [Online]. Available: http://whqlibdoc.who.int/publications/2003/9241562218.pdf [Accessed 17 July 2019].
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