The Project Lioneo: Nutrition of Very Low Birthweight Newborns Using a Concentrate with Human Milk Lyophilisate: Phase 1 Study for Safety and Tolerability

Introduction A human milk concentrate using lyophilizate from banked human milk has been recently developed. Preclinical tests showed that the human milk with human lyophilisate has an adequate nutrient composition, physical-chemical and bacteriological stability, immediately and after 3 and 6 months stored in freezer −20°C. This study aims to assess safety and tolerability of the human milk with human milk additive compared with the standard additive (cow’s protein milk).