CLINICAL EVALUATION OF POWDERED FORMULA IN PREMATURE INFANTS AFTER DISCHARGE

早产儿出院后配方粉的临床评估

• 批准号: 6277980
• 负责人: RICHARD J. SCHANLER
• 金额: $ 2.57万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6277980
• 关键词: baby food; body composition; clinical research; consumer product; developmental nutrition; dietary constituent; dietary mineral; human subject; human therapy evaluation; infant human (0-1 year); longitudinal human study; low birth weight infant human; milk; normal ossification; nutrition related tag; photon absorptiometry; posthospitalization care; questionnaires

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.

本研究旨在评估实验性配方奶粉 (NeoCare 22) 含有更高的蛋白质能量比和更高的 蛋白质和矿物质的浓度以确定是否是早产儿 在 12 年内将有更大的追赶性生长和骨矿化 与喂养标准配方奶粉的类似婴儿相比，一个月的周期 （类似20）。 该研究将检验以下假设：增长 NeoCare 喂养的健康早产儿的骨骼矿化和骨骼矿化 配方奶粉不会大于 Similac 喂养的婴儿 出院后前 12 个月内服用配方奶粉。 初级 感兴趣的变量包括重量和长度增量以及总计 身体骨骼质量。 蛋白质和矿物质生化指标、身体 成分（去脂体重、体脂百分比）和喂养耐受性将 次要变量。 NeoCare 配方中蛋白质含量增加 30%、50% 比 Similac 更多的钙和磷，以及 75% 的锌；两者都是铁强化的。 贝勒中心将招募 30 名婴儿，总共 68 名 预计完成多中心研究。 从他们到达的那一刻起 出院前体重为 1.8 公斤，研究婴儿将 只喂 NeoCare (NC) 或含铁 (SWI) 的 similac 配方奶粉 哺乳至出院后 12 个月。 婴儿将被录取 当它们达到 1.8 公斤并且完全口服喂养时进行研究。 他们 将被随机分配到研究组（NC 与 SWI）和所有配方奶粉 和混合设备将提供给医院和家庭 罗斯实验室。 入学后，将有5次预定的学习 出院后 8、16、26、40 和 52 周进行观察，以测量生长情况。 三天的牛奶摄入量记录和喂养耐受性日记将被记录 在医院内和每次就诊时收集。血清白蛋白、前白蛋白、 视黄醇结合蛋白、Ca、P、碱性磷酸酶和骨钙素 将在研究开始时以及第 16 周和第 52 周进行测量。 全身 使用 DEXA（双能 X 射线吸收法，QDR 2000， Hologic）和使用 [40]K 计数的去脂体重将在 研究开始时以及第 8、16 和 52 周时婴儿正在睡觉，但是 不是sedatd。 婴儿行为、喂养和粪便模式以及配方奶粉 家长将在8岁和16岁时完成满意度调查问卷 一周。