建立母乳喂养1、2和3月时生长速率曲线——基于母乳与配方粉喂养的多中心随机对照试验

发布时间：2018-04-16 03:21

本文选题：婴儿 + 母乳喂养　；参考：《中国循证儿科杂志》2017年02期

【摘要】：目的建立1~2月龄健康婴儿母乳喂养1、2和3月时的生长速率百分位曲线,为评价生长发育提供更全面的参考。方法采用多中心RCT方案,6个研究现场儿童保健科体检的胎龄37周、1~2月龄、性别不限、自动放弃母乳喂养的婴儿为配方粉组(按随机化原则分配至配方粉1亚组和配方粉2亚组),在相同研究现场与配方粉组单号性别、体重匹配的胎龄37周、1~2月龄、坚持母乳喂养的婴儿进入母乳组。主要观察指标为入组1、2和3月时身长、体重和头围的生长速率,月生长速率=[(本次随访的测量值-上次随访的测量值)/(本次实际随访时间-上次实际随访时间)天〗×30。次要观察指标:(1)入组1、2和3月时的大便形状和次数,根据婴儿家长手机拍摄新鲜大便照片按Bristol大便形状7分型图判断便型;(2)研究期间发生的不良事件。生长速率和便次、便型采用全分析集(FAS)分析,不良反应采用安全集(SS)分析。应用LMS软件,以偏度-中位数-变异系数(LMS)法表现入组1、2和3月时身长、体重和头围的生长速率的百分位数。结果 2016年5月6日至2016年10月30日征集到符合本研究纳入和排除标准的(SS集)配方粉组152名和母乳组72名,2组分别有24名和3名退出,FAS集分别为128名和69名。2组性别、入组时日龄、身长、体重、胎龄和生产方式差异无统计意义。(1)母乳组喂养1、2和3月时身长增长速率(厘米/月)分别为3.1±1.4、3.0±0.8和2.7±0.6,呈逐月下降趋势;体重增长速率(克/月)分别为951±371、824±278和749±219,呈逐月下降趋势;头围增长速率(厘米/月)分别为1.5±0.7、1.4±0.5和1.3±0.3,下降趋势缓慢。(2)在喂养1、2和3月时,配方粉组与母乳组身长、体重和头围增长速率差异均无统计学意义,亦呈逐月下降趋势。(3)入组时及喂养1、2和3月时,配方粉组大便次数和形状与母乳组差异有统计学意义。(4)224名(SS集)婴儿均未发生与配方粉或母乳喂养有直接关系的不良反应事件。结论 1~2月健康婴儿母乳喂养1、2和3月时身长、体重增长速率呈逐月下降趋势,头围增长速率下降趋势较身长和体重缓慢。配方粉喂养生长速率趋势同母乳。
[Abstract]:Objective to establish the growth rate percentile curves of 1-month and 2-month old healthy infants after breast-feeding for 1 and 3 months, so as to provide a more comprehensive reference for the evaluation of growth and development.Methods the gestational age of 37 weeks and 2 months was measured by multi-center RCT regimen. The age of gestational age was not limited to the age of 37 weeks or 2 months, and there was no restriction on sex.Infants who voluntarily forgo breastfeeding were assigned to formula powder group (randomly assigned to formula powder subgroup 1 and formula powder 2 subgroup). In the same study, the single sex and body weight matched gestational age of 37 weeks and 12 months of age were measured in the same study field with formula powder group.Babies who are breastfed enter the breast milk group.The main outcome measures were the body length, body weight and growth rate of the head circumference, and the monthly growth rate = [(the measured value of this follow-up-the measured value of the last follow-up)] 脳 30 days.Second, we should observe the shape and times of defecation at 1 / 2 and 3 months after 1: 1) and judge the adverse events according to the Bristol stool shape 7 type map according to the fresh defecation photos taken by the parents' mobile phone.The growth rate and feces were analyzed by FAS-FASA, and the adverse reactions were analyzed by safety cluster analysis (SSSS).By using LMS software, the percentiles of body length, body weight and growth rate of head circumference were measured by deviation median coefficient of variation (LMS) method at 1 ~ 2 and 3 months.Results from May 6, 2016 to October 30, 2016, 24 of 152 patients in the formula powder group and 72 in the breast milk group were recruited to meet the criteria for inclusion and exclusion of the study. The sex of the two groups were 128 and 69, respectively, and that of the two groups were 128 and 69, respectively.There was no significant difference in age, body length, body weight, gestational age and mode of production. The growth rate of body length (cm / month) was 3.1 卤1.4 卤3.0 卤0.8 and 2.7 卤0.6 in breast feeding group and 3 months, respectively, showing a decreasing trend month by month.The growth rate of body weight (g / month) was 951 卤371824 卤278,749 卤219g / month, and the growth rate of head circumference (cm / month) was 1.5 卤0.71.4,0.5,1.3 卤0.3, respectively.There was no significant difference in body weight and growth rate of head circumference.The number and shape of defecation in formula powder group were significantly different from those in breast milk group. There were no adverse events in infants with direct relation to formula powder or breast feeding.Conclusion the body length of healthy infants during 1 ~ 2 months and 3 months after breast-feeding showed a decreasing trend of body weight growth, and the decreasing trend of head circumference growth rate was slower than that of body length and body weight.The growth rate of formula powder is the same as that of breast milk.
【作者单位】：母乳与配方粉喂养多中心随机对照试验协作组;《中国循证儿科杂志》编辑部;福建省漳州市东浦头社区卫生服务中心;陕西省宝鸡市妇幼保健院;海南省妇幼保健院;陕西省宝鸡市眉县妇幼保健院;海南省海口市妇幼保健院;福建省漳州市芗城区天宝镇中心卫生院;福建省漳州市医院;陕西省眉县中医医院;复旦大学上海医学院统计学教研室;
【分类号】：R174.4

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