Personalized Nutrition with Banked Human Milk for Early Gut Microbiota Development: In Pursuit of the Perfect Match.

The correct initial colonization and establishment of the gut microbiota during the early stages of life is a key step, with long-lasting consequences throughout the entire lifespan of the individual. This process is affected by several perinatal factors; among them, feeding mode is known to have a critical role. Breastfeeding is the optimal nutrition for neonates; however, it is not always possible, especially in cases of prematurity or early pathology. In such cases, most commonly babies are fed with infant formulas in spite of the official nutritional and health international organizations' recommendation on the use of donated human milk through milk banks for these cases. However, donated human milk still does not totally match maternal milk in terms of infant growth and gut microbiota development. The present review summarizes the practices of milk banks and hospitals regarding donated human milk, its safety and quality, and the health outcomes in infants fed with donated human milk. Additionally, we explore different alternatives to customize pasteurized donated human milk with the aim of finding the perfect match between each baby and banked milk for promoting the establishment of a beneficial gut microbiota from the early stages of life.

Cost analysis of establishing and operating the first human milk bank at Da Nang Hospital for Women and Children in Vietnam: an activity-based costing ingredients study.

BACKGROUND: Breastfeeding is the biological norm for feeding infants and young children. When mothers' breastmilk is unavailable, donor human milk (DHM) from a human milk bank (HMB) becomes the next option for small vulnerable newborns. A comprehensive cost analysis is essential for understanding the investments needed to establish, operate, and scale up HMBs. This study aims to estimate and analyze such costs at the first facility established in Vietnam. METHODS: An activity-based costing ingredients (ABC-I) approach was employed, with the cost perspective from service provision agencies (specifically, the project conducted at Da Nang Hospital for Women and Children and Development Partners). Estimated financial costs, based on actual expenditures, were measured in 2023 local currency and then converted to 2023 US dollars (USD). We examined three scenarios: 1) direct start-up costs + indirect start-up costs + implementation costs, 2) direct start-up costs + implementation costs, and 3) capital costs + implementation costs over the 6.5 years of operation. RESULTS: The total start-up cost was USD 616,263, with total expenditure on direct activities at USD 228,131 and indirect activities at USD 388,132. Investment in equipment accounted for the largest proportion (USD 84,213). The monthly costs of Da Nang HMB were USD 25,217, 14,565, and 9,326, corresponding to scenarios 1, 2, and 3, respectively. Over HMB's 6.5 years of operation, on average, the unit costs were USD 166, USD 96, and USD 62 for DHM received and USD 201, USD 116, and USD 74 for pasteurized DHM meeting specified criteria in the corresponding scenarios. Unit costs were highest in the initial six months, decreased, and reached their lowest levels after a year. Then, the unit costs experienced an increase in late 2020 and early 2021. CONCLUSION: Although the unit cost of DHM in Da Nang HMB is comparable to that in certain neighboring countries, intentional measures to reduce disposal rates, improve HMB efficiency, motivate more community-based donors, and establish an HMB service network should be implemented to lower costs.

Impact of Holder Pasteurization and Preanalytical Handling Techniques on Fat Concentration in Donor Human Milk: A Scoping Review.

BACKGROUND: Donor human milk (DHM) is an essential source of nutrition among high-risk infants (e.g., premature and low-birth weight). Holder pasteurization, a common step in DHM processing, is known to partially alter the composition of DHM; however, the impact on fat composition is historically inconsistent. OBJECTIVES: This scoping review aimed to broadly review the literature on the impact of Holder pasteurization on the fat content in DHM, with a focus on preanalytical sample mixing. METHODS: A systematic search of original, peer-reviewed research articles was conducted on 11 July, 2022. Articles were included if they compared matched raw (control) and Holder-pasteurized human milk samples and measured total lipids, cholesterol, and individual classes of fatty acids. Article review and selection was conducted by 2 independent reviewers. RESULTS: The search yielded 26 original, peer-reviewed research articles published between 1978 and 2022. Overall methodology varied considerably between studies. When study methods described any mixing for collecting raw milk, 1 (17%) of the 6 of studies reported a small change in total fat concentration following pasteurization (<5%). Alternatively, among studies that did not describe methods for mixing raw milk to ensure a representative sample, 10 (56%) of the 18 reported a significant change (≥± 5%) in total fat concentration, with changes ranging from -28.6% to +19.4%. CONCLUSIONS: This review suggests that inconsistent findings regarding the impact of Holder pasteurization on fat may be related to study methodologies, particularly preanalytical sample mixing. More research considering the role of preanalytical handling procedures and methodologies is necessary to help clarify the impact of Holder pasteurization on human milk composition.

Microbiological status of donor human milk - A single center study from Poland.

Human milk is considered the most suitable source of nutrition for infants. Donor human milk from human milk banks (HMB) is recommended as the best alternative for infants whose mothers' own milk is unavailable. Microbiological screening of milk donated to HMB is important to ensure the quality and safety of the pasteurised human milk. This article describes the microbiological status of human milk donated to the Regional Human Milk Bank in Torun, Poland. Statistical data regarding the microbiological analysis of milk from 292 donors were collected in the years 2013-2021. Total of 538 milk samples were tested. Only in 6% of human milk samples the bacteria level was above the required standard and/or the milk had potentially pathogenic bacteria. The main core of donors' breastmilk bacteria represents the skin microbiota, and the composition of the microbiota is strictly related to the surrounding environment. The most abundant genera detected in milk samples were the Staphylococcus group. Prolonged hospitalisation of infants' mothers and/or offsprings is associated with potentially pathogenic bacteria colonization in milk. The use of the modern identification method MALDI-TOF resulted in more accurate results compared to the biochemical methods. Our analysis indicates that most of the tested milk samples (94%), both expressing at home and in hospital environments, meet the criteria for admission to the human milk bank. Effective techniques for identifying microorganisms ensure that donor milk from human milk banks meets the guidelines set for these units.

Effect of Holder Pasteurization, Mode of Delivery, and Infant's Gender on Fatty Acid Composition of Donor Breast Milk.

Breast milk (BM) plays a crucial role in providing essential fatty acids (FA) and energy for the growing infant. When the mother's own BM is not available, nutritional recommendations suggest donor milk (DM) in clinical and home practices. BM was collected from a variety of donor mothers in different lactation stages. Holder pasteurization (HoP) eliminates potential contaminants to ensure safety. FA content of BM samples from the Breast Milk Collection Center of Pécs, Hungary, were analyzed before and after HoP. HoP decreases the level of C6:0, C8:0, C14:1n-5c, C18:1n-9c, C18:3n-6c, C18:3n-3c, and C20:4n-6c in BM, while C14:0, C16:0, C18:1n-9t, C22:0, C22:1n-9c, C24:0, C24:1n-9c, and C22:6n-3c were found in elevated concentration after HoP. We did not detect time-dependent concentration changes in FAs in the first year of lactation. BM produced for girl infants contains higher C20:2n-6c levels. In the BM of mothers who delivered via cesarean section, C12:0, C15:0, C16:0, C17:0, C18:0, C18:1n-9t, C22:1n-9c levels were higher, while C18:2n-6c, C22:0, C24:0, and C22:6n-3c concentrations were lower compared to mothers who gave birth spontaneously. FAs in BM are constant during the first year of lactation. Although HoP modifies the concentration of different FAs, pasteurized DM provides essential FAs to the developing infant. Current data providing information about the FA profile of BM gives origination to supplementation guidelines.

Review of current best practices for human milk banking.

Mother's/parent milk is the optimal way to feed infants and when unavailable, supplemental donor human milk is preferred. A safe supply of donor human milk should be available for all low birthweight infants for whom it has been shown to reduce morbidity. Human milk banking has been in existence for more than a century, although largely shut down during the 1980s, primarily due to fears of human immunodeficiency virus transmission. With renewed security in milk banking, has come an exponential growth in human donor milk use. Guidelines for milk banking have been published in many countries including Australia, France, India, Italy, Spain, Switzerland, the United Kingdom and the nonprofit organization PATH. The European Milk Bank Association and the Human Milk Banking Association of North America have also published recommendations for milk banks throughout Europe and North America, respectively. Although there is variability among these guidelines, there is general consensus on quality control measures required to provide a supply of safe donor milk. These measures include effective donor screening, safe collection, transport and storage of milk, standardized pasteurization and bacteriological testing. Operational considerations are also critical, such as appropriate training for staff, equipment maintenance and cleaning, protocol and record keeping and inspection and accreditation. Clearly delineating these key quality control measures provides an excellent foundation for establishing international guidelines. Acceptable modifications must be established for low- and middle-income countries that do not have sufficient resources; overly burdensome guidelines may make establishing a milk bank unnecessarily prohibitive. This review presents a summary of current best practices for human milk banking.

A comparative review of human milk banking and national tissue banking programs.

This paper explores the legislative and operational commonalities and differences in Medical Products of Human Origin (MPHO) programs, including blood, hematopoietic cells, tissues and reproductive cells and human milk banking. The analysis includes ethical principles in donation and utilization, policies and legislation, public awareness and education, registries, guidelines in donor selection, safety and quality assurance, operational models and funding, infrastructure and human resources and biovigilance and evaluation of outcomes. Unlike other MPHO, the need for donor human milk (DHM) may be greatly reduced, that is, by ensuring optimal support for maternal lactation and breastfeeding. This should not be lost in the drive for wider and improved service provision. Nevertheless, increased overall demand for DHM is expected as a result of forthcoming international recommendations and also its increased use as the first-choice supplement to a mother's own milk both within and beyond preterm, low-birthweight and sick infant populations. Insight into current human milk banking highlights differences and gaps in practices that can benefit from further exploration and harmonization. Strong similarities with the ethical and operational principles underpinning donation and processing of the diverse MPHO suggest that legislating human milk banks within similar MPHO frameworks may bring additional safety and facilitate improved product quality. Moreover, that MPHO-inspired models operating within attainable regulatory requirements may contribute to sustainable human milk banking activity and growth.

The acceptability of a donor human milk bank and donated human milk among mothers in Limpopo Province, South Africa.

Breastfeeding is a crucial public health approach that reduces infant morbidity and mortality by providing essential nutrients and antibodies, and breast milk is easily digested. Breastfeeding and donated milk serve as a preventative measure against necrotising enterocolitis. Additionally, they protect against viruses and nosocomial sepsis. When a birthing parent's own milk is unavailable, alternative enteral nutrition for preterm or low-birth-weight infants is either donor human milk (DHM) or artificial formula. This study aimed to understand mothers' acceptance of the donor human milk bank (DHMB) and DHM. A qualitative phenomenological study was conducted in Limpopo Province, South Africa. The study used purposive sampling to select 23 mothers in postnatal and neonatal wards. Data collection was via in-depth interviews using a semistructured interview guide. Manual data analysis using an interpretative phenomenological analysis (IPA) framework was used to coding. Concepts were grouped to generate themes. Three themes and nine subthemes were generated: (1) DHMBs (2) cultural perspective of DHMB, and (3) health considerations of DHM. Participants were unaware of the DHMB. Hesitancy in accepting DHM due to fear of contracting HIV was observed. Cultural beliefs are an influencing factor for use, while donation was driven by altruistic reasons, preventing waste, helping others and having previously benefited from DHM. The study found that mothers are willing to donate human milk. Willingness to donate can be increased by raising awareness about DHMB and addressing culture and safety concerns at antenatal clinics.

Donation barriers, enablers, patterns and predictors of milk bank donors in the United States and United Kingdom.

Pasteurised donor human milk is recommended for very low birthweight infants who do not have access to their mother's milk. Although the use of donor milk continues to increase, little is known about the donation experiences of milk bank donors. We aimed to describe and compare enablers, barriers and patterns of human milk donation and identify factors predicting donation volume in a convenience sample of approved milk bank donors in the United Kingdom and the United States. A cross-sectional online survey was conducted from August 2022 to December 2022. Approved milk bank donors (n = 556) from three milk banks in the United States (n = 369, Mothers' Milk Bank of Florida, Mother's Milk Bank of North Texas and Northwest Mothers Milk Bank) and one milk bank in the United Kingdom (n = 187, Hearts Milk Bank) completed the survey. A substantial portion of donors in both settings reported participating in other forms of milk exchange (51% of U.S. donors vs. 39% of UK donors, p = 0.009). Top donation barriers reported in both settings were completing the serological screening and having enough space to store collected milk. Most donors started donating when their infant was 3 months old or older and reported donating mature milk. The most common source of information related to milk banking in each setting was the internet (United Kingdom-70% vs. United States - 63%, p = 0.112). Variables that predicted lifetime donation volume differed between the United States and the United Kingdom, highlighting the importance of setting-specific milk banking research.

Factors associated with informal human milk sharing among donors and recipients: A mixed-methods systematic review.

BACKGROUND: The multiple benefits associated with the provision of human milk exceed individual health outcomes, engendering substantial economic, societal and environmental domains. Human milk is the absolute, unparalleled source of nutrition for infants. Informal human milk sharing is a modernistic and rapidly progressing practice. No systematic review of the factors associated with this contemporary practice among donors and recipients of informal human milk sharing exists. AIM: The aim of this review was to identify, evaluate, synthesize and integrate the evidence on the factors associated with informal human milk sharing among donors and recipients. METHODS: A mixed methods systematic review was conducted according to the Joanna Briggs Institute methodological guidance utilizing a convergent integrated approach. The following databases were systematically searched: CINAHL, Scopus, Medline and Embase and Web of Science between inception to August 2023. A grey literature search was conducted using multiple techniques. This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RESULTS: Twenty-four studies were included in this review. Ten integrated findings relating to the factors associated with informal human milk sharing among donors and recipients were identified. The four integrated findings pertaining to donors included: altruistic motivation and value, resistance to commercialization and overcoming inaccessibility, uniting digital and personal connectedness and lack of awareness and acceptance of informal human milk sharing in healthcare settings. The six integrated findings relating to recipients included: maternal or infant factors, superiority and advantageous impact of breastmilk, human milk bank influences, digital connections and transparency, healthcare professional facilitation of informal human milk sharing, and professional and logistical implications. CONCLUSION: This review highlighted a multitude of factors that motivate, facilitate and impede the practice of informal human milk sharing. Future research is required to explore these factors further within broader geographical locations to enhance the generalizability and rigor of the body of knowledge. Further studies should consider the exploration of the experiences and psychological impact of informal human milk sharing on donors and recipients. The provision of human milk to all infants is an imperative public health endeavor and thus positioning this as a key benchmark for research and practice is crucial.

Motivators and barriers to the acceptability of a human milk bank among Malaysians.

The World Health Organisation (WHO) recommends that all babies be exclusively breastfed, stating that donor milk is the next best alternative in the absence of the mother's own milk. Milk sharing takes many forms, namely wet nursing, co-feeding, cross-feeding, and a human milk bank (HMB). However, the establishment of a human milk bank is still not widely accepted and is a debatable topic because of religious concerns in Malaysia. The aim of this study is to determine the facilitators and barriers among Malaysians towards the acceptance of an HMB. A cross-sectional study with 367 participants was conducted; the participants answered an online-validated, self-administered questionnaire. Data on sociodemographic, knowledge on breastfeeding benefits, knowledge and attitude on HMB-specific issues were analysed in terms of frequency before proceeded with multiple logistic regression. The majority of the respondents were Muslim (73.3%), had completed their tertiary education (82.8%), and were employed (70.8%). Only 55.9% of respondents had heard of HMB, stating the internet as their main source of information, but many respondents were agreeable to its establishment (67.8%). Most respondents had a good score on knowledge of breastfeeding benefits and on HMB-specific issues (70% and 54.2%, respectively), while 63.8% had a positive attitude towards HMB. In the multivariate analysis, mothers with a good score on general knowledge of breastfeeding (AOR: 1.715; 95% CI 1.047-2.808) were more likely to accept the establishment of HMB, while being a Muslim was negatively associated with its establishment (AOR = 0.113, 95% CI 0.050-0.253). The study found a high prevalence of mothers who were willing to accept the establishment of HMB. By educating mothers on the benefits of breastfeeding, as well as addressing their religious concerns, the establishment of a religiously abiding HMB in Malaysia may be accepted without compromising their beliefs or the health benefit of donor milk.

Caffeine Concentrations in Human Milk Donated to a Human Milk Bank in Japan.

BACKGROUND: Human milk banks have been established to provide human milk to preterm infants who are unable to obtain milk from their mothers. Donor screening methods vary, and prospective donors are commonly screened for drug and recreational substance use through behavioral screening. Although the risk of illegal drug consumption in Japan is extremely low, caffeine may be consumed unknowingly and can be found in human milk. To date, only a few reports have been conducted on the concentration of caffeine in donor milk. RESEARCH AIM: This study aimed to examine the pre-pasteurization levels of caffeine in human milk donated to a milk bank in Japan. METHODS: This was a cross-sectional, observational study of caffeine concentrations in human milk donated to a human milk bank in Japan. Caffeine concentration in the donor milk was measured using high-performance liquid chromatography. RESULTS: Caffeine was detected in 70% of the donor milk samples (N = 350). The median (range) of caffeine concentration was 0.46 [< 0.10, 7.54] mg/L, and 64.0% of the samples had less than 1 mg/L of caffeine. The caffeine concentration varied widely among as well as within individuals. CONCLUSION: The average caffeine concentration in Japanese donor milk samples was higher than that previously reported in samples from Spain, but the range was similar. Donors should be informed that caffeine intake should be within a moderate range, to further increase the safety of donor milk.

International expert meeting on the donation and use of human milk: Brief report.

Where a mother's own milk is not available or is insufficient, donor human milk (DHM) processed by a human milk bank (HMB) is the recommended next best alternative. HMBs exist in over 65 countries. However, most countries have yet to establish national policies or programmes that support the provision of DHM. In July 2019, a group of international experts in fields relevant to human milk banking gathered at a meeting organised by the Institute of Biomedical Ethics, University of Zurich, and co-sponsored by the World Health Organisation. Prompted by the growing interest globally in creating and sustaining HMBs and addressing current safety and ethical concerns and standards, the aims of the meeting were to define knowledge gaps, determine the need for and scope of global guidelines and provide recommendations on steps that need to be taken at the international level. Following wide-ranging discussions that included the integration of milk banks into health care systems, strategy and policy, quality and safety, the use of DHM and associated ethical considerations, the overall conclusion of the meeting was that in the absence of global recommendations on the implementation, operation and regulation of HMBs, evidence-based guidance is urgently needed.

The global status of human milk banking.

Human milk provides essential nutrition for infants and holds many health benefits for infants and mothers. When a mother's own milk is not available for her infant, the World Health Organization recommends feeding donor human milk (DHM) from a human milk banking facility. DHM is human milk produced, collected then donated to a human milk bank (HMB). HMBs serve many vital functions, including screening donor mothers, then collecting, processing, storing, and allocating DHM to recipients. The first HMB opened in 1909, and today there are more than 700 HMBs globally. Unfortunately, HMB facilities are not present in all locales, with notable gaps in South Asia and Africa. Additionally, there are no global standards to guide HMB operational procedures. Even though most HMBs attempt to employ quality control systems to provide safe DHM, differences in community needs, resource availability, and a range of methods and policies to execute processes result in significant variations in DHM quality and HMB operations. Robust and collaborative systems that ensure safe and equitable access to DHM are needed. In this paper, we present a global snapshot of current human milk banking practices; review an interdisciplinary framework to guide and support HMB activities as an integrated part of health and newborn care systems; discuss factors that contribute to HMB sustainability; outline barriers to scaling HMBs worldwide; and highlight knowledge, policy, and research gaps. Developing global HMB guidance and rigorous, adaptable standards would strengthen efforts to improve newborn health.

Influence of donor characteristics on the milk donation volume and microbiological quality of donated human milk in first 3 years of work of the Croatian human milk bank-retrospective observational study.

OBJECTIVES: Donated human milk is the best possible alternative when mother's own milk is not available. The aim of this study is to investigate whether there are differences in the milk donation volumes and microbiological quality of donated milk depending on human milk donors (HMDs) characteristics. METHODS: We analyzed data on the HMDs who donated milk in the first three years of work of human milk bank (HMB) - November 2019 to January 2023. The data on the volume of donated milk in L and suitable microbiological quality assessed by the number and isolated species of bacteria were collected from questionnaires filled out by HMDs and documentation administered by HMB employees and are presented using descriptive and comparative statistics. RESULTS: Two hundred HMDs were included in this study. The majority of them are between 26 and 35 years of age, reside in capital city or the surrounding county, have given birth to a full-term child vaginally, and express surplus milk through a breast pump. Donor mothers of preterm born infants (14.5 %) donated greater quantities, there is statistically significant difference in the median of volume of milk donated (9.6 vs. 6.4, p=0.026). Milk expressed manually shows better results in microbiological quality (median percentage 100 vs. 82 vs. 100, p=0.040), while by comparing other characteristics of the donors, no difference was found between the groups. CONCLUSIONS: It is important to be aware of the characteristics of previous HMDs in order to direct the HMB future promotional and educational activities.

A systematic review of contaminants in donor human milk.

Donor human milk (DHM) from a milk bank is the recommended feeding method for preterm infants when the mother's own milk (MOM) is not available. Despite this recommendation, information on the possible contamination of donor human milk and its impact on infant health outcomes is poorly characterised. The aim of this systematic review is to assess contaminants present in DHM samples that preterm and critically ill infants consume. The data sources used include PubMed, EMBASE, CINAHL and Web of Science. A search of the data sources targeting DHM and its potential contaminants yielded 426 publications. Two reviewers (S. T. and D. L.) conducted title/abstract screening through Covidence software, and predetermined inclusion/exclusion criteria yielded 26 manuscripts. Contaminant types (bacterial, chemical, fungal, viral) and study details (e.g., type of bacteria identified, study setting) were extracted from each included study during full-text review. Primary contaminants in donor human milk included bacterial species and environmental pollutants. We found that bacterial contaminants were identified in 100% of the papers in which bacterial contamination was sought (16 papers) and 61.5% of the full data set (26 papers), with the most frequently identified genera being Staphylococcus (e.g., Staphylococcus aureus and coagulase-negative Staphylococcus) and Bacillus (e.g., Bacillus cereus). Chemical pollutants were discovered in 100% of the papers in which chemical contamination was sought (eight papers) and 30.8% of the full data set (26 papers). The most frequently identified chemical pollutants included perfluoroalkyl substances (six papers), toxic metal (one paper) and caffeine (one paper). Viral and fungal contamination were identified in one paper each. Our results highlight the importance of establishing standardisation in assessing DHM contamination and future studies are needed to clarify the impact of DHM contaminants on health outcomes.

High hydrostatic pressure is similar to Holder pasteurization in preserving donor milk antimicrobial activity.

BACKGROUND: The microbiological safety of donor milk (DM) is commonly ensured by Holder pasteurization (HoP, 62.5 °C for 30 min) in human milk banks despite its detrimental effects on bioactive factors. We compared the antimicrobial properties of DM after Holder pasteurization treatment or High Hydrostatic Pressure processing (HHP, 350 MPa at 38 °C), a non-thermal substitute for DM sterilization. METHODS: We assessed lactoferrin and lysozyme concentrations in raw, HHP- and HoP-treated pools of DM (n = 8). The impact of both treatments was evaluated on the growth of Escherichia coli and Group B Streptococcus in comparison with control media (n = 4). We also addressed the effect of storage of HHP treated DM over a 6-month period (n = 15). RESULTS: HHP milk demonstrated similar concentrations of lactoferrin compared with raw milk, while it was significantly decreased by HoP. Lysozyme concentrations remained stable regardless of the condition. Although a bacteriostatic effect was observed against Escherichia coli at early timepoints, a sharp bactericidal effect was observed against Group B Streptococcus. Unlike HoP, these results were significant for HHP compared to controls. Stored DM was well and safely preserved by HHP. CONCLUSION: Our study demonstrates that this alternative sterilization method shows promise for use with DM in human milk banks. IMPACT: Antimicrobial activity of donor milk after High Hydrostatic Pressure treatment has not been clearly evaluated. Donor milk lactoferrin is better preserved by High Hydrostatic Pressure than conventional Holder pasteurization, while lysozyme concentration is not affected by either treatment. As with Holder pasteurization, High Hydrostatic Pressure preserves donor milk bacteriostatic activity against E. coli in addition to bactericidal activity against Group B Streptococcus. Donor milk treated by High Hydrostatic Pressure can be stored safely for 6 months.