Background

Preterm infants, particularly those with very low birth weight (VLBW, <1.5 kg), face a high risk of growth failure and severe complications such as necrotizing enterocolitis during the early stages of life. Adequate nutritional support is therefore essential for their survival and long-term development.

Human milk is widely recognized as the optimal source of nutrition for newborns due to its unique composition of nutrients, bioactive compounds and immunological factors. However, in the case of very small preterm infants, human milk alone often does not provide sufficient levels of protein and energy to meet their metabolic requirements.

For this reason, milk fortification is routinely applied in neonatal intensive care units.

Limitations of current fortification approaches

Currently available fortifiers are predominantly bovine-based, which raises several concerns:

  • differences in protein composition compared with human milk
  • potential clinical risks in extremely premature infants
  • ethical considerations regarding the use of bovine-derived products

Moreover, most current approaches rely on standard fortification, which does not account for the natural variability of human milk composition.

This variability means that infants may receive nutritional intake that differs significantly from their actual requirements.

Project concept

The PreciousHMFstudy project aims to develop and validate a novel bedside approach to individualized human milk fortification.

The concept combines two technological solutions:

Human Milk Analyzer (HMA)

A device enabling rapid determination of macronutrient composition of human milk directly in the clinical setting.

Babylat Enricher

A system enabling the preparation of human milk-derived fortifiers (HMDF) directly at the hospital site.

By integrating both technologies, clinicians will be able to:

  • measure the nutritional composition of milk
  • adjust fortification to the needs of a specific infant
  • prepare fortified milk safely within the hospital environment

Clinical validation

The project includes laboratory validation and a pilot clinical study involving 20–30 neonates.

The study will evaluate:

  • safety of fortified milk
  • tolerability in preterm infants
  • nutritional and biological quality of the fortified milk

This will provide essential data supporting the clinical feasibility of individualized human milk fortification.

International collaboration

The project is implemented by a Polish–Swiss consortium combining expertise in food science, biomedical engineering, clinical neonatology and medical device development.

Poland represents a particularly important environment for early adoption of the developed technology, as it is currently the only European country where donor human milk is reimbursed by the government.

This creates a unique opportunity to introduce and scale human milk-based fortification strategies.