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

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...

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Bibliographic Details
Published in:	British journal of nutrition Vol. 128; no. 12; pp. 2490 - 2497
Main Authors:	Nogueira-Pileggi, Vicky, Achcar, Maria Carolina, Carmona, Fábio, Carnevale da Silva, Adriana, Aragon, Davi Casale, da Veiga Ued, Fabio, Moraes de Oliveira, Mariana, Mara Monti Fonseca, Luciana, Garcia Alves, Larissa, Silva Bomfim, Vanessa, Beltramini Trevilato, Tania Maria, Condé Brondi Delácio, Mayara, Takeko Amorim Minakawa de Freitas, Cyntia, dos Santos Porto, Viviane, de Castro Barbosa Leonello, Daniela, de Paiva Martins, Natalia, Gasparini Marigheti Brassaro, Heloisa, Muyssi-Pinhata, Marisa Márcia, Camelo Junior, José Simon
Format:	Journal Article
Language:	English
Published:	Cambridge, UK Cambridge University Press 28-12-2022
Subjects:	Additives Animals Birth Weight Breast milk Cattle Clinical trials Cow's milk Diarrhea Distension Double-blind studies Enterocolitis Enterocolitis, Necrotizing Female Gastrointestinal diseases Gestational age Guardians Hospitals Humans Immunology Infant Infant, Newborn Infant, Premature Infant, Very Low Birth Weight Infants Innovative Techniques Low birth weight Milk Milk, Human Multiple regression analysis Necrosis Necrotizing enterocolitis Newborn babies Nurses Nutrition research Nutritionists Premature babies Proteins Regression models Regurgitation Sepsis Vomiting Weight Human milk Human milk bank Necrotising enterocolitis Lyophilisate Very-low-birth-weight infants Preterm newborn
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Summary:	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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3
ISSN:	0007-1145 1475-2662
DOI:	10.1017/S0007114521005110