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LioNeo project: a randomised double-blind clinical trial for nutrition of very-low-birth-weight infants.

Vicky Nogueira-Pileggi, Maria Carolina Achcar,Fábio Carmona,Adriana Carnevale da Silva,Davi Casale Aragon,Fabio da Veiga Ued,Mariana Moraes de Oliveira,Luciana Mara Monti Fonseca,Larissa Garcia Alves,Vanessa Silva Bomfim,Tania Maria Beltramini Trevilato, Mayara Condé Brondi Delácio, Cyntia Takeko Amorim Minakawa de Freitas, Viviane Dos Santos Porto, Daniela de Castro Barbosa Leonello, Natalia de Paiva Martins, Heloisa Gasparini Marigheti Brassaro,Marisa Márcia Muyssi-Pinhata,José Simon Camelo Junior

The British journal of nutrition(2022)

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Abstract
We assessed the effectiveness of lyophilised banked human milk (HM) as a fortifier to feed very-low-birth-weight infants (VLBWI). This study aimed to evaluate the safety and tolerability of HM with HM lyophilisate as an additive compared with the standard additive (cows' milk protein). In this phase I double-blind randomised controlled clinical trial, set in the intensive and intermediate care units of a tertiary hospital, forty VLBWI were enrolled and allocated into two groups: HM plus HM lyophilisate (LioNeo) or HM plus commercial additive (HMCA). The inclusion criteria were preterm infants, birth weight 750-1500 g, small or adequate for gestational age, exclusively receiving donor HM, volume ≥ 100 ml/kg per d and haemodynamically stable. Participants were followed up for 21 consecutive days. The primary outcome measures were necrotising enterocolitis (NEC), late-onset sepsis (LOS), death, gastrointestinal (GI) bleeding or perforation, diarrhoea, regurgitation, vomiting and abdominal distension. The LioNeo and HMCA groups had similar weights at baseline. The regression models showed no differences between the groups in terms of the primary outcomes. Diarrhoea, GI perforation, NEC and LOS were absent in the LioNeo group (one LOS and one NEC in the HMCA group). Multiple regression analysis with the total volume of milk as a covariate did not show significant differences. The lyophilisation of donor HM was considered safe and tolerable for use in stable haemodynamically VLBWI.
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Key words
Human milk,Human milk bank,Lyophilisate,Necrotising enterocolitis,Preterm newborn,Very-low-birth-weight infants
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