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Concentrating human milk: an innovative point-of-care device designed to increase human milk feeding options for preterm infants

Abstract

Objective

The purpose of this study was to determine whether a point-of-care osmotic device concentrates important human milk (HM) nutrients to support feeding neonates requiring high-nutrient, low-volume feedings.

Study design

Raw and pasteurized HM samples were concentrated to determine the effects of time and temperature on concentration. Concentrated samples were compared with matched baseline samples to measure changes in selected nutrient concentrations. Furthermore, changes in concentration of certain bioactive components of raw milk samples were measured.

Result

The device significantly increased the concentrations of the majority of the measured nutrient and bioactive levels (p < 0.05). Increasing temperature of HM from 4 to 37 °C increased the concentration rate >30%. In all cases, the concentration rate of pasteurized HM was greater than that of raw HM.

Conclusions

The osmotic concentration of HM is a promising option for neonatal nutrition. Further studies are needed to establish an evidence base for the practical applications of this point-of-care device.

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Fig. 1: Representative graph of milk volume over time varying milk type and temperature.
Fig. 2: Representative graph of membrane weight (% increase) varying milk type and temperature.
Fig. 3: Boxplots of Percent (%) Change in Nutrient vs Milk Concentration.

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Acknowledgements

We thank Dr. Naomi Bar-Yam of Mothers’ Milk Bank Northeast, Laraine Lockhart Borman of Mother’s Milk Bank of Colorado, Maryanne Perrin, the Human Milk Bank Association of North America Research Committee and the generous mothers who donated their milk. Funding was provided by the Colorado Office of Economic Development and International Trade. This work was also supported by the National Institute of Health Grants R01HD079404 (LDB) and S10OD023553 (LDB). The Human Milk Concentration device is not commercially available at the time of submission; this medical device is pre-FDA release to market, currently available only for research.

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Correspondence to Elizabeth R. Schinkel.

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Conflict of interest

Mother’s Milk Is Best (MMIB) Inc. is a neonatal medical device development company, that is pre-revenue and the HMC device process is pre-market and patent pending. MMIB Inc. was cofounded by ERS and ERN. MMIB Inc. has no corporate sponsors or partners. In 2019, MMIB Inc. received Phase I Small Business Innovation Research funding from the National Institute of Health for research in progress at the time of this submission. This research is independent of and does not reflect the views and beliefs of the UCHealth System, ERS’s NICU employer in Colorado. None of the university affiliated researchers who performed human milk nutrient analysis in this study have any equity or ownership of MMIB Inc. or other known conflicts of interest.

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Schinkel, E.R., Nelson, E.R., Young, B.E. et al. Concentrating human milk: an innovative point-of-care device designed to increase human milk feeding options for preterm infants. J Perinatol 41, 582–589 (2021). https://doi.org/10.1038/s41372-020-00820-x

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