CALCIUM ABSORPTION IN NEONATES FED WITH MOTHER'S MILK FORTIFIED WITH A DONOR

用捐赠者强化母乳喂养的新生儿的钙吸收

• 批准号: 7950643
• 负责人: STEVEN A ABRAMS
• 金额: $ 0.24万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7950643
• 关键词: Biological; Biological Availability; Body Composition; Body Weight; Bone Growth; Breast Feeding; Calcium; Cattle; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Data; Development; Effectiveness; Funding; Grant; Growth; Human Milk; Individual; Infant; Infection; Infection prevention; Institution; Intake; Milk; Milk Proteins; Minerals; Mothers; Necrotizing Enterocolitis; Neonatal; Nutrient; Nutritional Requirements; Outcome; Physiologic calcification; Powder dose form; Premature Infant; Proteins; Protocols documentation; Research; Research Personnel; Resources; Risk; Source; Testing; United States National Institutes of Health; Very Low Birth Weight Infant; base; bone; calcium absorption; design; efficacy trial; feeding; meetings; neonate; nutrition; premature

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Breast milk is considered the nutrition of choice for infants, including premature infants in the Neonatal ICU (NICU). In the case of very low birth weight (VLBW) infants, this milk is generally supplemented with a human milk fortifier (HMF) in order to provide the additional nutrients that these babies require. We propose to investigate a HMF made from pasteurized donor human milk, in particular regarding calcium absorption, growth, bone mineral status, body composition, and feeding tolerance. We hypothesize that these study parameters will result in adequate outcomes with the use of the donor milk based HMF. The use of a human milk fortifier made from pasteurized donor human milk will provide adequate calcium absorption to preterm infants. In addition, this new fortifier will provide adequate growth and bone mineralization. SPECIFIC AIMS: Primary Aim: To determine calcium absorption in premature infants fed mother's own milk fortified with pasteurized donor human milk fortifier. Secondary Aims: (1) To evaluate the growth, bone mineral status, and body composition of premature infants fed mother's own milk fortified with pasteurized donor human milk fortifier, and, (2) To assess feeding tolerance (pilot data) in infants fed mother's own milk fortified with pasteurized donor human milk. BACKGROUND AND SIGNIFICANCE:Infants who are premature and below about 2.0 kg have unique nutritional requirements including a need for higher intakes of protein and minerals on a body weight basis than full-term infants. Routine cow's milk based formula as well as mother's own milk are insufficient to meet those requirements. Therefore, virtually all infants < 2.0 kg are fed either their own mother's milk fortified with a cow's milk based powdered infant fortifier or, if the mother does not proved an adequate volume of her milk or chooses not to breast feed, they will receive a cow's milk based formula designed for premature infants. Although these products have been used for many years and have been shown to be relatively safe and effective, persistent concerns exist regarding an increased risk of infections and necrotizing enterocolitis (NEC) in premature infants who receive cow's milk based feeding products. It has been shown that feeding tolerance is enhanced and NEC risk is decreased in infants receiving human milk, although the specific benefits of avoiding all cow's milk protein are uncertain. The possibility of safely and effectively avoiding the use of all cow's milk based products has recently become possible due to the development of a human milk-based fortifier made from pasteurized donor human milk (Prolact-plus, Prolacta Bioscience, Monrovia, CA). The effectiveness of this fortifier in preventing infections and NEC will be tested in a multi-center trial in 2007. To date, it has been used only in individual cases and in smaller growth trials. However, the biological equivalence of using this newer donor milk product is not known. Specifically, the appropriate level and bioavailability of calcium, which is critical for preterm infants has not been tested from a donor milk product such as the Prolact-Plus. Therefore, we are conducting this study to determine the calcium and bone mineral effects of this product, using a protocol similar to that which will be used in the upcoming multi-center efficacy trial.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 母乳被认为是婴儿的营养选择，包括新生儿ICU（NICU）中的早产儿。在极低出生体重（VLBW）婴儿的情况下，这种牛奶通常补充有人乳强化剂（HMF），以提供这些婴儿所需的额外营养素。我们建议研究由巴氏灭菌供体人乳制成的HMF，特别是关于钙吸收、生长、骨矿物质状态、身体组成和喂养耐受性。我们假设，这些研究参数将导致使用供体乳汁为基础的HMF的充分结果。 使用由巴氏灭菌的供体人乳制成的人乳强化剂将为早产儿提供足够的钙吸收。此外，这种新的强化剂将提供足够的生长和骨矿化。 具体目标：主要目的：测定母乳中添加巴氏灭菌供体人乳强化剂的早产儿钙吸收情况。 次要目标：（1）评价用巴氏灭菌供体人乳强化剂强化的母乳喂养的早产儿的生长、骨矿物质状态和身体组成，（2）评估用巴氏灭菌供体人乳强化的母乳喂养的婴儿的喂养耐受性（试点数据）。 背景和意义：早产儿和低于约2.0 kg的婴儿具有独特的营养需求，包括需要比足月婴儿更高的蛋白质和矿物质摄入量（基于体重）。常规的以牛奶为基础的配方奶以及母亲自己的牛奶不足以满足这些要求。因此，几乎所有< 2.0 kg的婴儿都被喂食用基于牛乳的粉末状婴儿强化剂强化的他们自己的母乳，或者如果母亲没有证明足够的母乳量或选择不母乳喂养，他们将接受为早产儿设计的基于牛乳的配方奶粉。尽管这些产品已经使用多年，并且已经被证明是相对安全和有效的，但对于接受基于牛奶的喂养产品的早产儿中感染和坏死性小肠结肠炎（NEC）的风险增加存在持续的担忧。研究表明，母乳喂养的婴儿喂养耐受性增强，NEC风险降低，尽管避免所有牛奶蛋白的具体益处尚不确定。 最近，由于开发了一种由巴氏灭菌供体人乳制成的人乳强化剂（Prolact-plus，Prolacta Bioscience，蒙罗维亚，CA），安全有效地避免使用所有基于牛乳的产品的可能性已成为可能。这种强化剂在预防感染和NEC方面的有效性将在2007年的多中心试验中进行测试。迄今为止，它仅用于个别病例和较小的生长试验。然而，使用这种较新的供体奶制品的生物等效性尚不清楚。具体来说，钙的适当水平和生物利用度，这是早产儿的关键还没有从捐赠的奶制品，如催乳素加测试。因此，我们正在进行这项研究，以确定该产品的钙和骨矿物质的影响，使用的方案类似于即将进行的多中心疗效试验。