CLINICAL EVALUATION OF POWDERED FORMULA IN PREMATURE INFANTS AFTER DISCHARGE

本研究旨在评估一种实验性配方奶粉 （NeoCare 22）含有更大的蛋白质与能量比和更高的蛋白质与能量比。 蛋白质和矿物质的浓度，以确定是否早产儿 将有更大的追赶增长和骨矿化超过12- 一个月的时间比类似的婴儿喂养一个标准的长期配方奶粉 （Similac 20）。 该研究将检验以下假设： 喂养NeoCare的健康早产儿的骨骼矿化 配方奶粉将不大于喂养Similac的婴儿 在出院后的前12个月内， 主 感兴趣的变量包括重量和长度增量以及总 身体骨骼质量。 蛋白质和矿物质生化指标，身体 组成（瘦体重，%体脂）和喂养耐受性将是 次要变量。 NeoCare配方含有30%以上的蛋白质， 更多的钙和磷，和75%以上的锌比Similac;两者都是铁强化。 贝勒研究中心将入组30名婴儿，共68名 预计将完成多中心研究。 从他们到达 1.8出院前体重为kg，研究婴儿将 喂食NeoCare（NC）或含铁（SWI）粉末配方的类似物作为唯一的 母乳喂养至出院后12个月。 婴儿将被纳入 当他们达到1.8公斤，完全口服喂养时，研究。 他们 将被随机分配至研究组（NC与SWI），所有配方奶粉 和混合设备将提供给医院和家庭， 罗斯实验室。 研究入组后，将有5项计划研究 分别于出院后8、16、26、40、52 wk处死动物，测定生长情况。 三天的牛奶摄入量记录和喂养耐受性日记将 在医院内和所有访视时采集。血清白蛋白，前白蛋白， 视黄醇结合蛋白、钙、磷、碱性磷酸酶和骨钙素 将在研究入组时以及16和52周时测量。 全身 使用DEXA（双能X射线吸收测定法，QDR 2000， 使用[40]K计数测量Hologic）和瘦体重， 研究开始时以及8、16和52周时，婴儿正在睡觉， 不是镇静剂。 婴儿行为、喂养和粪便排泄以及配方奶粉 父母在8岁和16岁时填写满意度问卷 wk.

This study is designed to evaluate an experimental powdered formula (NeoCare 22) containing a greater protein to energy ratio and higher concentrations of protein and minerals to determine if preterm infants will have greater catch-up growth and bone mineralization over a 12- month period than similar infants fed a standard term powdered formula (Similac 20). The study will test the following hypothesis: growth and skeletal mineralization of healthy preterm infants fed NeoCare powdered formula will be no greater than for infants fed Similac powdered formula during the first 12 months post-discharge. The primary variables of interest include weight and length increments and total body skeletal mass. Protein and mineral biochemical indices, body composition (lean body mass, %body fat), and feeding tolerance will be secondary variables. NeoCare formula contains 30% more protein, 50% more Ca and P, and 75% more zinc than Similac; both are iron fortified. 30 infants will be enrolled at the Baylor site, a total of 68 are expected to complete the multicenter study. From the time they reach 1.8 kg body weight prior to hospital discharge, study infants will be fed NeoCare (NC) or similac with Iron (SWI) powdered formula as the only milk feeding to 12 months post-discharge. Infants will be enrolled into the study when they reach 1.8 kg and are completely fed orally. They will be randomized to study group (NC vs. SWI) and all powdered formulas and mixing equipment will be provided to the hospital and families by Ross Laboratories. After study entry, there will be 5 scheduled study wisits, 8,16,26,40, & 52 wk after hospital discharge, to measure growth. Three-day milk intake records and feeding tolerance diaries will be collected in-hospital and at all visits. Serum albumin, prealbumin, retinol-binding protein, Ca, P, alkaline phosphatase, and osteocalcin will be measured at study entry and at 16 and 52 wk. Total body mineralization using DEXA (dual energy x-ray absorptiometry, QDR 2000, Hologic) and lean body mass using [40]K counting will be measured at study entry and at 8,16, and 52 wk while the infants are sleeping but not sedatd. Infant behavior, feeding and stool paterns, and formula satisfaction questionnaires wil be completed by the parents at 8 and 16 wk.