Structured Lactation Support and Establishment of Human Donor Milk Banks in Neonatal Centres

Human milk, especially mother's own milk (MOM), is vital for newborns and crucial for very low birth weight (VLBW, under 1500 grams) preterm infants, who face increased vulnerability. As the production of MOM may be impeded by preterm birth, lactation support and the establishment of human donor milk banks (HDMBs) played an important role in providing human donor milk (HDM) when MOM was fully or initially absent. The study evaluated the effectiveness, implementation and economic aspects of an intervention that aimed to ensure access to MOM or HDM for VLBW infants from the first day of life in German neonatal intensive care units (NICUs). The study was designed as a hybrid type 1 effectiveness-implementation cluster-randomised controlled trial (c-RCT) using a stepped-wedge design and was conducted in 15 level I and level II NICUs across Germany over 26 months. VLBW infants and their mothers received either standard care or the Neo-MILK intervention according to the NICU's group status. The primary outcome was the proportion of VLBW infants exclusively fed with MOM at NICU discharge. Secondary outcomes at infant level included feeding patterns, complications, length of stay and frequency of feeding with HDM. Maternal-level secondary outcomes covered lactation and breastfeeding decision and behaviour. A process evaluation and an economic analysis accompanied the study. The data set comprised primary quantitative and qualitative data as well as secondary data from medical records. Statistical analysis was performed using generalised linear mixed models. Data collection, storage and analysis complied with current data protection regulations. The study received ethical approval from the Ethics Committee of the Medical Faculty of the University of Cologne and the local ethics committees of the participating NICUs. Results were disseminated through peer-reviewed publications and on the project website.