New alternatives to holder pasteurization in processing donor milk in human milk banks.

Infectious and toxicological risks are the main potential hazards that operators of Human Milk Banks (HMBs) encounter and must eliminate. HMBs are trying to implement procedures that allow to manage and sanitize human milk without altering significantly its nutritional and biologically protective components, obtaining a product characterized by a valid balance between safety and biological quality. The history of human milk processing is linked to the origins of HMBs themselves. And although other forms of sterilization were used originally, pasteurization soon became the recognized most effective means for sanitizing milk: all the milk that arrives at the HMB must be pasteurized. Holder pasteurization (HoP) is the most used methodology, and it is performed using low temperature and long time (+62.5°C for 30 min). With HoP some bioactive milk components are lost to varying degrees, but many other precious bioactive compounds are completely or partially preserved. To improve the quality of human milk processed by HMBs, maintaining in the meantime the same microbiological safety offered by HoP, new technologies are under evaluation. At present, High-Temperature Short-Time pasteurization (HTST) and High-Pressure Processing are the most studied methodologies. HTST is already utilized in some HMBs for daily practical activity and for research purposes. They seem to be superior to HoP for a better preservation of some nutritional and biologically protective components. Freeze-drying or lyophilization may have advantages for room temperature storage and transportation. The aim of this study is to evaluate the advancement regarding the processing of DHM with a literature search from 2019 to 2022. The effects of the new technologies on safety and quality of human milk are presented and discussed. The new technologies should assure microbiological safety of the final product at least at the same level as optimized HoP, with an improved preservation of the nutritional and bioactive components of raw human milk.

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.

Stability of individualized neonatal parenteral nutrition admixtures with fish oil and high calcium content.

Introduction: Introduction: the stability of total parenteral nutrition admixtures for neonates (TPNAn) has been questioned in relation to the interaction between calcium and fish oil emulsions. Aim: the aim of this study was to check the stability (particle size < 1 µm) of different individualized TPNAn prepared with fish-oil emulsion and containing calcium at concentrations ranging from 10 to 20 mmol/L. Methods: admixtures analyzed: twelve different formulations with SMOFlipid® 20 % (conserved for 24 h and for 96 h), three formulations with Lipoplus® 20 % (conserved for 96 h) and three formulations with SMOFlipid® 20 % with Multi-12K1® Pediatric (conserved for 96 h). Two bags were compounded for each formulation and conservation period. Measurements on each admixture bag: particle standardized diameter by laser diffraction technique and pH by a calibrated pH-meter. Data analysis with mixed linear regression models. Results: maximum particle size was < 0.8 µm for all investigated admixtures. Lipid concentration of 5 g/L and sodium and potassium concentration of 100 mmol/L slightly increased the proportion of particles > 0.6 µm. Ninety six hours storage also increased the percentage of particles > 0.6 µm (+0.143 ± 0.07; p = 0.038) but did not influence other parameters. No association with calcium composition was observed. Amino acid content was inversely correlated with pH (-0.83; p < 0.0001). Conclusions: the studied individualized parenteral nutrition admixtures for newborns that contain fish oil emulsions and meet cation requirements are stable for at least 96 hours.

Introducción: Introducción: existe controversia sobre la estabilidad de las mezclas de nutrición parenteral total para recién nacidos (TPNAn) con emulsiones de omega-3 y alto contenido en calcio. Objetivo: estudiar la estabilidad (tamaño de partículas < 1 µm) de diferentes TPNAn individualizadas preparados con una emulsión lipídica que contiene w3 y concentraciones de calcio entre 10 y 20 mmol/L. Métodos: se analizaron doce formulaciones diferentes con SMOFlipid® 20 % (conservadas durante 24 h y por 96 h), tres formulaciones con Lipoplus® 20 % (conservadas durante 96 h) y tres formulaciones con SMOFlipid® 20 % con Multi-12K1® Pediatric (conservadas durante 96 h). Se prepararon dos bolsas por cada formulación y período de conservación. Se midieron el diámetro de partícula estandarizado mediante técnica de difracción láser y el pH con un pH-metro calibrado. Análisis de datos con modelos de regresión lineal mixta. Resultados: el tamaño máximo de partícula fue < 0,8 µm para todas las mezclas investigadas. La concentración de lípidos de 5 g/L y la concentración de sodio y potasio de 100 mmol/L aumentaron ligeramente la proporción de partículas > 0,6 µm. El almacenamiento de noventa y seis horas también aumentó el porcentaje de partículas > 0,6 µm (+0,143 ± 0,07; p = 0,038) pero no influyó en otros parámetros. No se observó asociación con la concentración de calcio. El contenido de aminoácidos se correlacionó inversamente con el pH (-0,83; p < 0,0001). Conclusiones: las TPNAn individualizadas estudiadas con emulsiones de omega-3 que incluyen los requerimientos de cationes son estables durante al menos 96 horas.