Oliveira Renata G, Achcar-Feih Maria C, Nogueira-Pileggi Vicky, Carnevale-Silva Adriana, Carmona Fabio, Aragon Davi C, Oliveira Mariana M, Fonseca Luciana M M, Alves Larissa G, Bomfim Vanessa S, Trevilato Tânia M B, Spido-Dias Isabela, Ued Fabio V, Mussi-Pinhata Marisa M, Camelo Jose S
Department of Pediatrics, Ribeirão Preto Medical School, University of São Paulo, Brazil.
Department of Maternal-Infantile and Public Health, Nursing School of Ribeirão Preto, University of São Paulo, Brazil.
J Pediatr (Rio J). 2025 Mar-Apr;101(2):187-193. doi: 10.1016/j.jped.2024.08.007. Epub 2024 Oct 5.
The aim of this study was to assess whether the micronutrients zinc and copper, provided by human milk additives, are sufficient for very low birth weight preterm infants.
A phase 1 randomized double-blind controlled trial was conducted with very low birth weight preterm infants. This is a secondary analysis of copper and zinc. Sixty-six newborns were part of the initial sample, with forty participating and reaching the final stage of the study. Inclusion criteria were: gestational age less than 37 weeks, birth weight greater than or equal to 750 g and less than or equal to 1500 g, small or appropriate for gestational age, exclusively receiving human milk at a volume greater than or equal to 100 mL per kilogram per day, and hemodynamically stable. Participants were randomly assigned to two groups: intervention, Lioneo (received human milk with additive based on lyophilized human milk), n = 20, and control, HMCA (received human milk with commercial additive based on cow's milk protein), n = 20, and their serum levels of zinc and copper were measured on the first and twenty-first days.
There was a reduction in intragroup zinc serum levels from the first to the twenty-first day of the study (p < 0.01). There was no intergroup difference. No difference was found in serum copper levels.
Human milk additives were not sufficient to maintain adequate zinc serum levels in very low birth weight newborns. It was not possible to affirm whether human milk additives were sufficient to maintain adequate serum copper levels in the studied sample. UTN: U1111-1220-0550.
本研究旨在评估人乳添加剂提供的微量营养素锌和铜是否足以满足极低出生体重早产儿的需求。
对极低出生体重早产儿进行了一项1期随机双盲对照试验。这是对铜和锌的二次分析。初始样本中有66名新生儿，40名参与并进入研究的最后阶段。纳入标准为：胎龄小于37周，出生体重大于或等于750克且小于或等于1500克，小于或适于胎龄，每天仅接受大于或等于每千克100毫升的人乳，且血流动力学稳定。参与者被随机分为两组：干预组，Lioneo（接受含基于冻干人乳的添加剂的人乳），n = 20；对照组，HMCA（接受含基于牛乳蛋白的商业添加剂的人乳），n = 20，并在第1天和第21天测量他们的血清锌和铜水平。
在研究的第1天到第21天，组内血清锌水平有所下降（p < 0.01）。组间无差异。血清铜水平未发现差异。
人乳添加剂不足以维持极低出生体重新生儿的血清锌水平。无法确定人乳添加剂是否足以维持研究样本中的血清铜水平。试验编号：U1111-1220-0550。
