Objective To describe the growth velocity percentile curves under breast feeding for 3 months for healthy breastfed infants aged 1 to 2 months,which can provide a more comprehensive reference for the evaluation of infant growth and development.Methods A multi-center randomized clinical trial was performed.1~2 months old infants(gestational age ≥37 weeks)fed with formula milk only for mothers' own problems presented in child health clinics of six study settings were included in formula powder group(and then randomly assigned to commercially available formula subgroup 1 or commercially available formula subgroup 2);In the same study setting,1~2 months old infants(gestational age ≥37 weeks)with exclusively breast feeding matched by gender and body weight with formula powder group were included in breast feeding group.The primary outcomes were growth velocity of height,body weight and head circumference at 1,2 and 3 months.The monthly growth velocity was equal to [(measured value at this actual follow-up time-measured value at last actual follow-up time)/(this actual follow-up time-the last actual follow-up time)d] ×30.The secondary outcomes were ①the stool character and defecation frequency at the enrolment and 1,2 and 3 months after enrolment.The parents collected fresh stool and snapped photos on their phones and the stool characters were judged according to Bristol stool shape chart.②Incidence of adverse events and serious adverse events over the trial period.Full analysis set(FAS)for effectiveness analysis and evaluation of defecation frequency and stool character and safety set(SS)for adverse events were performed.The coefficient of skewness-median-coefficient of variation(LMS)method was applied to calculate smoothed height,body weight and head circumference percentiles(P3、P5、P10、P25、P50、P75、P90、P95、P97)at 1,2,3 months by LMS software.Results From May 6,2016 to October 30,2016,152 infants were included in formula powder group and 72 in breast feeding group respectively(SS).The numbers of drop-out were 24 in formula powder group and 3 in breast feeding group.The numbers of participants included in FAS were 128 for formula powder group and 69 for breast feeding group respectively.There was no significant difference in gender,day age at enrolment,height,body weight,gestational age and delivery mode between two groups(FAS).①In breast feeding group,the growth velocity of height was 3.1±1.4 cm at 1 month,3.0±0.8 cm at 2 months and 2.7±0.6 cm at 3 months,which showed a downward trend month by month;the growth velocity of body weight was 951±371 g at 1 month,824±278 g at 2 months and 749±219 g at 3 months,which showed a downward trend month by month;the growth velocity of head circumference was 1.5±0.7 cm at 1 month,1.4±0.5 cm at 2 months and 1.3±0.3 cm at 3 months,which showed a slow downward trend month by month.② No significant difference was found between formula powder group and breast feeding group in the growth velocity of height,body weight and circumference at 1,2 and 3 months respectively.The growth velocity of height,body weight and circumference in formula powder group also showed a downward trend month by month.③There was significant difference in both defecation frequency and stool character at enrolment,1,2 and 3 months between formula powder group and breast feeding group.④None of adverse events was considered directly attributable to formula powder or breast feeding in totally 224 infants during the study period.Conclusion The growth velocity of height,body weight and head circumference under breast feeding for 3 months of Chinese healthy breast feeding infants aged 1~2 months showed a downward trend month by month.The downward change month by month of growth velocity in head circumference was slower than that of height and body weight.The growth velocity trend in formula powder feeding infants was similar to that in breast feeding infants.%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.④224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.
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