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.

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.

Conceptualizing the Commercialization of Human Milk: A Concept Analysis.

BACKGROUND: Donor human milk is recommended when infants are unable to be fed their mother's own milk or require supplementation. For-profit companies use technologies to create human milk products for infants in the neonatal intensive care setting without consistent guidelines and regulatory frameworks in place. This commercialization of human milk is inadequately conceptualized and ill-defined. RESEARCH AIMS: The aim of this study is to conceptualize and define the commercialization of human milk and discuss the need for policy guidelines and regulations. METHOD: Using a concept analysis framework, we reviewed the literature on the commercialization of human milk, analyzed the antecedents and potential consequences of the industry, and developed a conceptual definition. The literature review resulted in 13 relevant articles. RESULTS: There has been a surge in the development and availability of human milk products for vulnerable infants developed by for-profit companies. Commercialized human milk can be defined as the packaging and sale of human milk and human milk components for financial gain. Factors contributing to the commercialization of human milk include an increased demand for human milk, and consequences include potential undermining of breastfeeding. The lack of guidelines and regulations raises concerns of equity, ethics, and safety. CONCLUSION: The industry is rapidly growing, resulting in an urgent need for consistent guidelines and regulatory frameworks. If left unaddressed, there could be potential risks for donor milk banking, the future of breastfeeding, and infant and maternal health.

Human milk products in the National Health Service: a cross-sectional survey of use and industry contact across England's trusts.

Objectives: Commentators and professional organisations note that an expanding market in human milk-based products (HMBPs) could reduce breastfeeding, compromising maternal and infant health, and undermine public milk bank donations. We investigate whether English NHS trusts purchased these products and whether HMBP companies have marketed to them. Design: Freedom of Information (FOI) requests asking: (1) whether trusts obtained human milk; (2) if so, how; and (3) whether HMBP companies had approached them. We analysed trusts' responses qualitatively. In 2023, an FOI request to the Food Standards Authority (FSA) following a product recall. Setting: England. Participants: One hundred and ninety-four NHS trusts, the FSA. Main Outcome Measures: Obtaining human milk, approaches by companies, and trust responses to approaches. Results: One hundred and seventy-six trusts responded, 102 reporting human milk from milk banks. No trusts reported purchasing from companies in 2022. In 2023, the FSA confirmed six English hospitals used HMBPs from one company; an FOI for trusts' names was refused on law enforcement grounds. Two trusts reported participating in clinical trials funded by companies. Twenty-one reported approaches, using several strategies, including uninvited ward visits. Trusts rejected marketing based on guidance from: (1) trust dieticians or physicians; (2) regional regulatory bodies; (3) professional bodies; and (4) perceived application of an International Code on breastfeeding. Conclusions: Companies market to trusts, adopting methods previously used by the formula industry. Trusts express confusion over whether this infringes agreements designed to promote breastfeeding. We encourage clarification and guidance for professionals and trusts to ensure safety, infant and maternal health, and protect public provision.

Early enteral nutrition with exclusive donor milk instead of formula milk affects the time of full enteral feeding for very low birth weight infants.

This study investigated the effects of exclusive donor milk or formula in the first 7 days after birth, on the time to full enteral feeding, growth, and morbidity of adverse events related to premature infants. This was a retrospective study carried out from July 2014 to December 2019 at the Department of Neonatology of Shanghai Children's Hospital. All infants with a birth weight < 1,500 g and a gestational age ≤ 32 who received exclusive donor milk or formula in the first 7 days after birth were included in this study. The time to full enteral feeding (defined as 150 mL/kg) in the donor milk group was significantly shorter than in the formula group (18 vs. 22 days, p = 0.01). Donated breast milk was also associated with a lower incidence of NEC (4.4 vs. 7%, p < 0.01), ROP (3.8 vs. 13.2%, p < 0.01), and culture-confirmed sepsis (11 vs. 22.6%, p < 0.01). Using donated breast milk instead of current formula milk for early enteral nutrition can shorten the time to full enteral feeding and reduce the incidence of NEC, ROP, and sepsis.

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.

Clinical Impact of Supplementation with Pasteurized Donor Human Milk by High-Temperature Short-Time Method versus Holder Method in Extremely Low Birth Weight Infants: A Multicentre Randomized Controlled Trial.

Nosocomial infections are a frequent and serious problem in extremely low birth weight (ELBW) infants. Donor human milk (DHM) is the best alternative for feeding these babies when mother's own milk (MOM) is not available. Recently, a patented prototype of a High-Temperature Short-Time (HTST) pasteurizer adapted to a human milk bank setting showed a lesser impact on immunologic components. We designed a multicentre randomized controlled trial that investigates whether, in ELBW infants with an insufficient MOM supply, the administration of HTST pasteurized DHM reduces the incidence of confirmed catheter-associated sepsis compared to DHM pasteurized with the Holder method. From birth until 34 weeks postmenstrual age, patients included in the study received DHM, as a supplement, pasteurized by the Holder or HTST method. A total of 213 patients were randomized; 79 (HTST group) and 81 (Holder group) were included in the analysis. We found no difference in the frequency of nosocomial sepsis between the patients of the two methods-41.8% (33/79) of HTST group patients versus 45.7% (37/81) of Holder group patients, relative risk 0.91 (0.64-1.3), p = 0.62. In conclusion, when MOM is not available, supplementing during admission with DHM pasteurized by the HTST versus Holder method might not have an impact on the incidence of catheter-associated sepsis.

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.

Long-term benefits of exclusive human milk diet in small for gestational age neonates: a systematic review of the literature.

Evidence about feeding practices' consequences in small for gestational age newborns is not well established because they are less likely to initiate and continue breastfeeding than other newborns. Our aim was to study current knowledge about the benefits of exclusive human milk diet after 2 years of age in small for gestational age newborns. A systematic review of the literature was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline criteria. Pubmed and Scopus were searched for studies published from databases inception until June 2, 2023. Included articles were analysed and synthesised. Risk of bias and level of evidence assessments were performed. They were enrolled small for gestational age newborns fed by breastfeeding, breast milk or donor milk. The systematic review included 9 articles which were related to 4 health domains: neurodevelopment, cardiovascular, somatic growth and bone mineralization and atopy. Extracted data support a beneficial effect of breastfeeding on these outcomes. Better quality of evidence and longer follow-up are needed.

Effect of Donated Premature Milk in the Prevention of Bronchopulmonary Dysplasia.

INTRODUCTION: Breastfeeding is one of the strategies that has been shown to be effective in preventing severe forms of bronchopulmonary dysplasia (BPD). When mother's own milk (MOM) is not available, pasteurized donor milk (DM) is the best alternative. However, the evidence is inconclusive on the difference in the incidence of bronchopulmonary dysplasia (BPD) between patients fed MOM and those fed with DM. As standard DM is usually mature pooled milk donated by mothers who have delivered their babies at term, the potential benefits of preterm milk may be lost. MATERIALS AND METHODS: An observational, retrospective, single-center study was conducted in the neonatology department of a high-complexity hospital. The study included newborns <32 weeks of gestational age born between January 2020 and December 2022. When supplemental milk was needed, non-pooled preterm pasteurized donor milk (PDM) matched for gestational age and moment of lactation was used in this study, classifying preterm infants in two groups: mainly MOM (>50% of the milk) or mainly PDM (>50% of the milk). Two groups were established: those who received >50% MOM and those who received >50% PDM. They were also classified according to the diagnosis of DBP: one group included no BPD or grade 1 BPD (noBPD/1), while the other included grade 2 or 3 BPD (BPD 2-3). The objectives of this study were, firstly, to evaluate the incidence of BPD 2-3 among patients who predominantly received PDM versus MOM. Secondly, to analyze differences in the type of human milk received and its nutritional components, as well as to study the growth in patients with or without BPD. RESULTS: One hundred ninety-nine patients were included in the study. A comparison of noBPD/1 versus BPD 2-3 groups between those receiving mainly MOM versus PDM showed no significant differences (19% vs. 20%, p 0.95). PDM colostrum in BPD 2-3 compared to noBPD/1 was higher in protein content (2.24 g/100 mL (SD 0.37) vs. 2.02 g/100 mL (SD 0.29) p < 0.01), although the statistical significance decreased after adjustment for gestational age and birth weight z-score (OR 3.53 (0.86-14.51)). No differences were found in the macronutrients in the mature milk of patients feeding more than 50% PDM in both study groups. Growth of BPD 2-3 showed a greater decrease in the difference in z-scores for height at birth and at discharge compared to noBPD/1 (-1.64 vs. -0.43, p 0.03). CONCLUSIONS: The use of mainly MOM or PDM demonstrates a similar incidence of noBPD/1 or BPD 2-3. Non-pooled and matched by gestational age and time of lactation preterm donor milk can probably be an alternative when mother's own milk is not available, with a similar protective effect in the prevention of severe BPD.

Comparison of prematurity-related outcomes and complications in very low birth weight (VLBW) neonates fed with mother`s own milk versus donor milk: a comparative study.

BACKGROUND: When mother`s own milk (MOM) is unavailable or insufficient, donor milk (DM) from a human milk bank serves as an alternative feeding option. Our study sought to investigate and compare the outcomes and complications of very low birth weight (VLBW) preterm infants who receive MOM versus DM. METHODS: In this retrospective cohort study conducted between 2018 and 2022, we compared 70 VLBW preterm infants exclusively fed with DM to 70 randomly selected counterparts fed with MOM. Both groups began enteral feeding within 72 hours of birth. Various clinical outcomes were investigated during a three-month follow-up. The clinical outcomes were compared via independent t-tests, Mann-Whitney U, and Fisher`s exact test. RESULTS: The mean gestational age of the infants who were included was 29.6 ± 1.6 weeks, 84 (60%) were males, and the average birth weight was 1217 ± 151 grams. Both groups had similar baseline characteristics. The results of the study demonstrated no statistically significant differences between the groups in terms of hospital length of stay (37±16.3 days in MOM vs 40.3±16.9 days in DM group, P= 0.17), growth rate (13±4 gram/day in MOM vs 13±4 gram/day in DM group, P=0.51), growth velocity (9.8±3.0g/kg/d in MOM vs 9.5±3.2 g/kg/d in DM group), infants with in-hospital vomiting (51 cases in MOM vs 59 cases in DM group, P=0.15),vomiting frequency (1.3±1.1 times in MOM vs 1.5±1.0 times in DM group), incidence of retinopathy of prematurity (ROP) (4 cases in MOM vs 5 cases in DM group, P > 0.999) and incidence of bronchopulmonary dysplasia (BPD) (7 cases in MOM vs 6 cases in DM group, P > 0.999). CONCLUSION: Our study findings indicate that the utilization of DM didn`t have a substantial negative impact on infants` outcomes nor any complications in comparison with MOM.

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.

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.

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.

Milk microbiome transplantation: recolonizing donor milk with mother's own milk microbiota.

Donor human milk (DHM) provides myriad nutritional and immunological benefits for preterm and low birthweight infants. However, pasteurization leaves DHM devoid of potentially beneficial milk microbiota. In the present study, we performed milk microbiome transplantation from freshly collected mother's own milk (MOM) into pasteurized DHM. Small volumes of MOM (5%, 10%, or 30% v/v) were inoculated into pasteurized DHM and incubated at 37 °C for up to 8 h. Further, we compared microbiome recolonization in UV-C-treated and Holder-pasteurized DHM, as UV-C treatment has been shown to conserve important biochemical components of DHM that are lost during Holder pasteurization. Bacterial culture and viability-coupled metataxonomic sequencing were employed to assess the effectiveness of milk microbiome transplantation. Growth of transplanted MOM bacteria occurred rapidly in recolonized DHM samples; however, a greater level of growth was observed in Holder-pasteurized DHM compared to UV-C-treated DHM, potentially due to the conserved antimicrobial properties in UV-C-treated DHM. Viability-coupled metataxonomic analysis demonstrated similarity between recolonized DHM samples and fresh MOM samples, suggesting that the milk microbiome can be successfully transplanted into pasteurized DHM. These results highlight the potential of MOM microbiota transplantation to restore the microbial composition of UV-C-treated and Holder-pasteurized DHM and enhance the nutritional and immunological benefits of DHM for preterm and vulnerable infants. KEY POINTS: • Mother's own milk microbiome can be successfully transplanted into donor human milk. • Recolonization is equally successful in UV-C-treated and Holder-pasteurized milk. • Recolonization time should be restricted due to rapid bacterial growth.

Características y motivaciones de las mujeres donantes del banco de leche en el Complejo Asistencial Dr. Sótero del Río / Characteristics and motivations of donors to the human milk ba nk in Dr. Sótero del Rio Hospital, Chile

El propósito de este trabajo fue describir las características, motivaciones, barreras y fuentes de información de las mujeres donantes del Banco de Leche en el Complejo Asistencial Dr. Sótero del Río (CASR). MÉTODO: El diseño utilizado en este estudio correspondió a uno de tipo transversal descriptivo. Se realizó una encuesta telefónica con 15 preguntas a 82 mujeres que fueron donantes en al menos una oportunidad en el banco de leche del CASR desde el año 2015 a septiembre de 2017. Se estimaron proporciones para las variables categóricas y medidas de tendencia central y de dispersión para la edad Se calcularon intervalos de confianza al 95%. RESULTADOS: La edad media de las donantes fue de 31,3 años con una desviación estándar de 4,6. El 92,7% se encontraba casada o en convivencia y un 58,5% (IC 95% 47,1 - 69,3) cursó educación profesional superior completa. La principal motivación para donar fue la empatia (41,5% [IC 95% 30,7 - 52,9]) y las principales fuentes de conocimiento fueron internet/redes sociales 43,9% (IC 95% 33,0 - 55,3) y personal de salud 32% (IC 95% 22,9 - 44,2). CONCLUSIONES: La mujer donante del banco de leche del CASR, se encuentra principalmente casada o en convivencia, posee un alto nivel educacional y trabaja fuera del hogar. Estos resultados podrían orientar estrategias al fortalecimiento del banco de leche.

This study sought to describe characteristics, motivations, barriers, and sources of information of human milk donors to the milk bank at Dr. Sótero del Río Hospital, Chile. METHODS: A descriptive and cross - sectional study was carried out. We conducted a 15-question telephone survey in 82 women who were at least one-time milk donors between 2015 and 2017. Statistical analysis included frequencies and percentages for categorical variables and measures of central tendency and dispersion for quantitative variables. We calculated 95% confidence intervals (CI). RESULTS: The mean age of donors was 31.34,6 years; 92.7% were married or were living with their partner and 58.5% (95% CI of 47.1- 69.3) had completed higher education. The main motivation for donating was helping others (41.5% [95% CI of 30.7- 52.9]). The primary sources of knowledge on milk donations were the internet and social networks (43.9% [IC 95% 33.0- 55.3]), followed by health personnel 32% (95% CI of 22.9- 44.2). CONCLUSIONS: The donor profile in CASR's milk bank is a young woman, with a stable partner and high educational level. These results could provide useful information to improve strategies for human milk donation.