我们的目的是使用随机双盲试验来确定饲喂基于山羊奶的婴儿配方奶粉(GMF)的新生儿的生长和安全性参数。其中牛奶配方(CMF)作为对照,母乳喂养(BF)作为参考。
从25个欧洲研究中心招募了年龄达14天的健康足月婴儿(n=218),并随机分配到GMF或CMF。重量,长度,在基线测量头围,在研究诊所的14、28、56、84和112天。记录不良事件和粪便特征,反流,挑剔,绞痛,父母在3天的日记中自我报告了胀气。将人体测量值转换为WHO标准化的年龄和性别调整的z评分。协方差分析和线性混合模型用于统计分析生长,同时在研究母乳喂养组(n=86)时调整潜在的混杂因素。
比较GMF与CMF组,112天干预后,体重增加[平均差227.8g(95%CI-16.6~-439.0)]和人体测量的z评分相似.从84天开始,婴儿配方奶粉组的平均(SD)体重z评分高于BF组(GMF:0.28(0.84),CMF:0.12(0.88),BF-0.19(1.02),P<0.05),而身长和头围z评分相似。严重不良事件和反流的发生率,挑剔,绞痛,三组的肠胃胀气相似。
我们的数据表明GMF提供了足够的增长,具有良好的耐受性,并且在婴儿中使用是安全的。
We aimed to determine the growth and safety parameters in newborns fed a goat milk based infant formula (GMF) using a randomized double-blind
trial, in which a cow milk formula (CMF) served as a control and a breast fed (BF) group as a reference.
Healthy term infants (n = 218) aged up to 14 days were recruited from 25 European
study centers and randomized to GMF or CMF. Weight, length, head circumference were measured at baseline, and at 14, 28, 56, 84, and 112 days at the
study clinics. Adverse events were recorded and stool characteristics, reflux, fussiness, colic, and flatulence were self-reported by parents in 3-day diaries. Anthropometric measurements were transformed to WHO standardized age- and sex-adjusted z -scores. Analyses of covariance and linear mixed modeling were used to statistically analyze growth, while adjusting for potential confounders when studying the breast-fed group (n = 86).
Comparing the GMF to the CMF group, weight gain [mean difference 227.8 g (95% CI -16.6 to -439.0)] and z-scores for anthropometric measurements were similar after 112 days intervention. Infant formula groups showed greater mean (SD) weight z-scores than the BF group from 84 days onwards (GMF: 0.28 (0.84), CMF: 0.12 (0.88), BF -0.19 (1.02), P < 0.05), whereas length and head circumference z-scores were similar. Incidences of serious adverse events and reflux, fussiness, colic, and flatulence were similar among the three groups.
Our data demonstrate that GMF provides adequate growth, has a good tolerability, and is safe to use in infants.