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LioNeo Project - A randomized double-blind phase 2 clinical trial for nutrition of very-low-birth weight infants: A new gold standard?

2025-12-13 pediatrics Title + abstract only
View on medRxiv
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Fortification of human milk (HM) is essential to meet the nutritional needs of very low birthweight infants (VLBWI). Most available fortifiers are derived from cows milk, raising concerns about tolerability, immunogenicity and access in low-resource settings. LioNeo is a novel multinutrient fortifier produced exclusively from freeze-dried donor HM by a certified Human Milk Bank in Brazil. Preclinical and Phase 1 testing demonstrated safety and tolerability. This Phase 2 trial evaluated the effic...

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