Title: Innovative Technologies for Personalized Human Milk Fortification in Preterm Care: From Industrialization to Clinical Validation
Acronym: PreciousHMFstudy
Short description:
A novel bedside solution for individualized human milk fortification for preterm infants
Preterm infants, especially those with very low birth weight (VLBW, <1.5 kg), require highly specialized nutrition to support optimal growth and reduce the risk of serious complications such as necrotizing enterocolitis. Although human milk is the optimal nutritional source, it often does not provide sufficient protein and energy to meet the needs of these infants.
The PreciousHMFstudy project develops an innovative clinical solution enabling safe, individualized human milk fortification directly at the bedside. The approach combines on-site preparation of human milk-derived fortifiers (HMDF) with immediate macronutrient analysis, allowing precise adjustment of milk composition to the needs of each infant.
This Polish–Swiss collaboration brings together academic institutions, clinicians and technology developers to deliver a first-in-class, regulation-ready solution for neonatal nutrition.
Key objectives
The project focuses on three main objectives:
Technology development
Preparation of the Babylat Enricher device for market introduction, including engineering refinement, documentation and manufacturing workflows.
Human milk analysis
Further development of the Babylat Human Milk Analyzer (HMA) through sensor optimization and advanced analytical algorithms enabling accurate bedside macronutrient analysis.
Clinical validation
Evaluation of the safety and tolerability of individualized human milk fortification through laboratory validation and a pilot clinical study in preterm infants.
Project partners
The project is carried out by an international consortium combining clinical, scientific and technological expertise:
- Gdańsk University of Technology (Poland) – project coordination, validation studies and microbiological safety assessment
- Medical University of Gdańsk (Poland) – clinical pilot study in preterm infants
- Babylat AG (Switzerland) – development and market readiness of the Babylat Enricher
- PREMS LLC (Poland) – development of the Human Milk Analyzer
Why this project matters
Very low birth weight infants require precise nutritional support during the first weeks of life. Current fortification approaches are mainly based on bovine-derived products, which may raise clinical and ethical concerns.
The PreciousHMFstudy project introduces a new paradigm in neonatal nutrition:
- individualized fortification based on real-time milk analysis
- use of human milk-derived fortifiers
- bedside preparation within the clinical environment
- improved safety and nutritional precision
This approach may significantly improve nutritional management of preterm infants and support the development of new standards in neonatal care.
Funding
This project is funded by the Swiss-Polish Cooperation Programme within the Applied Research Programme NCBR – Innosuisse 2025.
Project title: PreciousHMFstudy
Project agreement number: SPPW/PreciousHMFstudy/0027/2025-00
Total project budget: 4 419 466.98 PLN
Funding amount: 3 616 016.53 PLN