LioNeo project: a randomised double-blind clinical trial for nutrition of very-low-birth-weight infants.
Vicky Nogueira-PileggiMaria Carolina AchcarFábio CarmonaAdriana Carnevale da SilvaDavi Casale AragonFabio da Veiga UedMariana Moraes de OliveiraLuciana Mara Monti FonsecaLarissa Garcia AlvesVanessa Silva BomfimTania Maria Beltramini TrevilatoMayara Condé Brondi DelácioCyntia Takeko Amorim Minakawa de FreitasViviane Dos Santos PortoDaniela de Castro Barbosa LeonelloNatalia de Paiva MartinsHeloisa Gasparini Marigheti BrassaroMarisa Márcia Muyssi-PinhataJosé Simon CameloPublished in: The British journal of nutrition (2022)
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.
Keyphrases
- low birth weight
- human milk
- preterm infants
- preterm birth
- clinical trial
- double blind
- gestational age
- birth weight
- late onset
- placebo controlled
- study protocol
- open label
- phase ii
- phase iii
- randomized controlled trial
- weight gain
- palliative care
- quality improvement
- early onset
- intensive care unit
- physical activity
- aortic valve
- insulin resistance
- coronary artery disease
- pain management