Development of a human milk concentrate with human milk lyophilizate for feeding very low birth weight preterm infants: A preclinical experimental study

Abstract

Breast milk is considered the gold standard nutritional resource for very low birth weight (VLBW) infants in terms of nutrients and protective factors. If mother's milk is not available, the second choice is donated and fortified human milk (HM) from the Human Milk Bank (HMB). This study hypothesized that HM could be lyophilized and used as an additive to increase the levels of macronutrients and micronutrients available to VLBW infants. This study aimed to constitute a lyophilized HM concentrate and determine the osmolality and the concentration of macronutrients and micronutrients in HM samples at “baseline” and in “HM concentrates”, analyzed immediately (HMCI), and after 3 (HMC3m) and 6 (HMC6m) months of freezing. Osmolality was verified using the freezing point osmometric method. Macronutrient quantification was performed using the MIRIS Human Milk Analyzer. Micronutrients were determined by Flame Atomic Absorption Spectrophotometry and by the automated colorimetric method. Bayesian linear mixed effect models were adjusted using OpenBUGS to estimate mean differences and 95% credibility intervals (CrI) of osmolality and of macro- and micronutrients between the types of HM samples. A comparison of dosage values showed a significant increase between HM baseline and HMCI, HMC3m, and HMC6m. Comparing HM baseline and HMCI highlighted the increase in energy content and the concentration of carbohydrates and total lipids. The Ca and P contents increased and the levels of energy, total lipids, and Cu were reduced in HMC3m compared to HMCI. Ca, Mg, K, Zn, and P increased and the levels of energy, total lipids, and Cu were reduced in HMC6m, compared to HMCI. The present study confirms the possibility of formulation and utilization of the immediate concentrate. Partial stability of HM concentrates generated from freeze-drying of donated milk do not recommend storage.

Essential and toxic elements in human milk concentrate with human milk lyophilizate: A preclinical study

“…This cross-sectional study was part of a recently published report approved by the Human Research Ethics Committee of the Clinics Hospital, Ribeirão Preto Medical School - USP (HREC Report No. 738.080), regarding development of a HM-concentrate with HM lyophilizate ( Oliveira et al, 2019 ). Voluntary donors of surplus HM production were informed about the nature of the study, signed a free and informed consent form, and underwent clinical and serological screening.…”

“…Procedures applied to formulate HM-Baseline and HM-Concentrate samples in the HMB at the Clinics Hospital of Ribeirão Preto were recently reported ( Oliveira et al, 2019 ). Briefly, HM-baseline samples were initially separated into two aliquots of 80 and 125 mL each: the 80 mL aliquot was considered the HM-baseline sample.…”

“…An innovative recent study produced HM-concentrate from a simple and inexpensive method of direct lyophilization of donated breast milk ( Oliveira et al, 2019 ). This concentrated HM demonstrated microbiological safety, acceptable osmolality, and suitable nutritional composition of the main macro- and micronutrients needed by a VLBW preterm infant.…”

Combination of High-Pressure Processing and Freeze-Drying as the Most Effective Techniques in Maintaining Biological Values and Microbiological Safety of Donor Milk

“…The most beneficial method for maintaining the bioactive components of human milk is lyophilization alone. According to the results reported by Oliviera, the nutritional value after 3 and 6 months of storage remains within the acceptable standards; however, there is only a slight reduction in potassium and copper [ 26 ]. Moreover, the process of lyophilization fails to ensure microbiological purity, which disqualifies freeze-drying alone for HMB.…”

“…Furthermore, the powder can be easy to reconstitute at a given volume to obtain the required caloric and nutrition value of milk for preterm infants [ 25 , 26 ].…”