Novel At-Home Mother's Milk Conductivity Sensing Technology as an Identification System of Delay in Milk Secretory Activation Progress and Early Breastfeeding Problems: Feasibility Assessment.

Abstract

Background: Prolonged exclusive breastfeeding is a public health priority and a personal desire by mothers; however, rates are low with milk supply challenges as a predominant cause. Early breastfeeding management at home is key. Milk electrolytes, mainly sodium ions, are accepted as biomarkers of secretory activation processes throughout the first weeks after birth and predictors for prolonged breastfeeding success, although they are not incorporated into routine care practice.

Objective: The aim of this study was to test the feasibility of a novel handheld smartphone-operated milk conductivity sensing system that was designed to compute a novel parameter, milk maturation percent (MM%), calculated from milk sample conductivity for tracking individual secretory activation progress in a real-world home setting.

Methods: System performance was initially evaluated in data collected from laboratory-based milk analysis, followed by a retrospective analysis of observational real-world data gathered with the system, on the spot in an at-home setting, implemented by lactation support providers or directly by mothers (N=592). Data collected included milk sample sensing data, baby age, and self-reported breastfeeding status and breastfeeding-related conditions. The data were retroactively classified in a day after birth-dependent manner. Results were compared between groups classified according to breastfeeding exclusivity and breastfeeding problems associated with ineffective breastfeeding and low milk supply.

Results: Laboratory analysis in a set of breast milk samples demonstrated a strong correlation between the system's results and sodium ion levels. In the real-world data set, a total of 1511 milk sensing records were obtained on the spot with over 592 real-world mothers. Data gathered with the system revealed a typical time-dependent increase in the milk maturation parameter (MM%), characterized by an initial steep increase, followed by a moderate increase, and reaching a plateau during the first weeks postpartum. Additionally, MM% levels captured by the system were found to be sensitive to breastfeeding status classifications of exclusive breastfeeding and breastfeeding problems, manifested by differences in group means in the several-day range after birth, predominantly during the first weeks postpartum. Differences could also be demonstrated for the per-case time after birth-dependent progress in individual mothers.

Conclusions: This feasibility study demonstrates that the use of smart milk conductivity sensing technology can provide a robust, objective measure of individual breastfeeding efficiency, facilitating remote data collection within a home setting. This system holds considerable potential to augment both self-monitoring and remote breastfeeding management capabilities, as well as to refine clinical classifications. To further validate the clinical relevance and potential of this home milk monitoring tool, future controlled clinical studies are necessary, which will provide insights into its impact on user and care provider satisfaction and its potential to meet breastfeeding success goals.