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).

Materials and Methods The study is a double-blind, randomized, controlled clinical trial. Forty very low birth weight infants (VLBWI) were divided in two groups, human milk plus human lyophilizate (LioNeo), and human milk plus commercial additive (LHFM85). Inclusion criteria: preterm babies (<37 weeks’ gestational age [wGA]), birthweight 750 to 1,500 g, small or adequate for gestational age, receiving exclusively human milk, volume equals to 100 mL/kg/day or higher, hemodynamically stable, and whose parents or responsibles signed the informed consent. Exclusion criteria were large for gestational age, malformations, grade III and IV for peri and intraventricular hemorrhages and children from underage mothers without a responsible companion. Participants were computer randomly assigned to receive either LioNeo or LHFM85 during 21 consecutive days.

Main Outcomes are necrotizing enterocolitis (NEC), late-onset neonatal sepsis and death, gastrointestinal bleeding and perforation, diarrhea, regurgitation, vomiting, and abdominal distension (>10%).

Results The main characteristics were similar between the groups: 1,220 ± 200 g and 30.4 ± 2.7 wGA for LioNeo group and 1,219 ± 204 g and 29.7 ± 1.8 wGA for LCFM85 group at baseline. The regression model based on a double Poisson distribution showed no differences between groups comparing the means of adverse outcomes. Diarrhea, gastrointestinal perforation, NEC, and neonatal sepsis were not observed in the group LioNeo and therefore were not statistically compared (one late onset sepsis and one NEC in group LCFM85). We also compared groups using a regression model with total volume of milk as an adjusted variable and there were no differences between the groups. We had no deaths during the study. Babies from both groups grew up similarly.

Conclusion The lyophilizate of human milk was considered safe and tolerable to use in hemodynamically stable VLBWI.

Conflict of Interest

None declared.