Structured lactation support for mothers of very low birthweight preterm infants and establishment of human donor milk banks in German NICUs (Neo-MILK): protocol for a hybrid type 1 effectiveness-implementation cluster-randomised controlled trial.

backgroundHuman milk, especially mother's own milk (MOM), is vital for newborns and crucial for very low birthweight (VLBW, <1500 g) preterm infants, who face increased vulnerability. As the production of MOM may be impeded due to preterm birth, it is important to provide lactation support and establish human donor milk (HDM) banks to provide HDM when MOM is fully or initially absent. This protocol describes the design of a study evaluating the effectiveness, implementation and economic aspects of an intervention, which aims to ensure access to MOM or HDM for VLBW infants from the first day of life in German neonatal intensive care units (NICUs). METHODS AND ANALYSIS: The hybrid type 1 effectiveness-implementation cluster-randomised controlled trial, using a stepped-wedge design, will be conducted in 15 level I and level II NICUs across Germany over 26 months. VLBW infants and their mothers will receive either standard care or the Neo-MILK intervention according to the NICU's group status. The primary outcome is the proportion of VLBW infants exclusively fed with MOM at NICU discharge. Secondary outcomes at infant level include feeding patterns, complications, length of stay and frequency of feeding with HDM. Maternal-level secondary outcomes cover lactation/breastfeeding decision and behaviour. A process evaluation and an economic analysis will accompany the study. The data set comprises survey and interview data and routinely collected data from medical records. Statistical analysis will be performed using generalised linear mixed models. ETHICS AND DISSEMINATION: Data collection, storage and analysis comply with current data protection regulations. This study has 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 will be disseminated through peer-reviewed publications and on the project website. TRIAL REGISTRATION NUMBER: DRKS00025058.