EVALUATION OF THE USE OF DONOR HUMAN MILK FOR INFANTS WITH ABDOMINAL WALL DEFECT

这个子项目是利用资源的许多研究子项目之一。 由NIH/NCRR资助的中心拨款提供。对子项目的主要支持 子项目的首席调查员可能是由其他来源提供的， 包括美国国立卫生研究院的其他来源。为子项目列出的总成本可能 表示该子项目使用的中心基础设施的估计数量， 不是由NCRR赠款提供给次级项目或次级项目工作人员的直接资金。 摘要 我们建议评估用全人乳蛋白饮食喂养腹壁缺陷(AWD)婴儿的短期效果，并与包括奶牛乳蛋白的饮食进行比较。婴儿母亲将提供她们自己的母乳，当有母乳供应时将使用这些母乳。其余的饮食将由捐赠者的母乳组成。如果需要，将使用以母乳为基础的母乳强化剂(HMF)来强化母乳。比较将基于完全肠外营养(TPN)天数和完全肠道喂养天数(150毫升/公斤/天)、培养证实的脓毒症、坏死性小肠结肠炎(NEC)、死亡、生长、胆汁淤积、碱性磷酸酶峰值活性和喂养不耐受发生率的主要终点。对照组将是2006-2009年间护理的匹配婴儿组(每个登记的婴儿有两个历史对照)。还将对2006-2009年的婴儿和目前的队列进行总体比较。 一、假说 我们假设，完全喂食人类乳蛋白(与奶牛乳蛋白相比)的AWD婴儿将有更好的喂养耐受性(根据从完全喂养到完全喂养的天数和总TPN天数来定义)，并且较少出现长期肠外营养的并发症(如感染、TPN相关的肝脏疾病和死亡)。 二、具体目标 我们将进行病例对照、队列研究，以评估使用母乳为基础的营养对患有AWD的婴儿的潜在短期益处。婴儿母亲将提供她们自己的母乳(母亲自己的牛奶，妈妈)，当可用时将使用。其余的饮食将由捐赠者的母乳组成。如果需要，将使用以母乳为基础的母乳强化剂(HMF)来强化母乳。脱氢表雄酮和以人奶为基础的羟甲基纤维素钠将由普罗拉科塔生物科学公司提供。结果将与H-23634方案中的历史对照进行比较。 比较将基于完全肠外营养(TPN)天数和完全肠道喂养天数(150毫升/公斤/天)、培养证实的脓毒症、坏死性小肠结肠炎(NEC)、死亡、生长、胆汁淤积、碱性磷酸酶峰值(AP)和喂养不耐受发生率的主要终点。对照组将是2006-2009年间护理的匹配婴儿组(每个登记的婴儿有两个历史对照)。还将对2006-2009年的婴儿和目前的队列进行总体比较。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. ABSTRACT We propose to evaluate the short-term effects of feeding infants with abdominal wall defects (AWD) with a diet of entirely human milk protein compared with a diet including cows milk protein. Infants mothers will provide their own breast milk which will be used when available. The remainder of the diet will consist of donor human milk. If needed, human milk fortification will be accomplished using a human milk based human milk fortifier (HMF). Comparisons will be based on the primary endpoint of days of total parenteral nutrition (TPN) as well as days to full enteral feeding (150 mL/kg/day), culture-proven sepsis, necrotizing enterocolitis (NEC), death, growth, cholestasis, peak alkaline phosphatase activity, and incidence of feeding intolerance. The comparison group will be a matched group of infants (2 historical controls for each enrolled infant) cared for between 2006-2009. Overall comparisons will also be made between infants from 2006-2009 and the current cohort. I. HYPOTHESIS We hypothesize that infants with AWD that are fed exclusively human milk protein (vs cows milk protein) will have improved feeding tolerance (as defined by days to full feeds and total TPN days) and have less complications of long term parenteral nutrition (such as infection, TPN related liver disease and death). II. SPECIFIC AIMS We will conduct a case control, cohort study to evaluate the potential short-term benefits of using human milk based nutrition for infants with AWD. Infants mothers will provide their own breast milk (mothers own milk, MOM) which will be used when available. The remainder of the diet will consist of donor human milk. If needed, human milk fortification will be accomplished using a human milk based human milk fortifier (HMF). The DHM and human milk based HMF will be provided by Prolacta Biosciences, Inc. Outcomes will be compared to historical controls from protocol H-23634. Comparisons will be based on the primary endpoint of days of total parenteral nutrition (TPN) as well as days to full enteral feeding (150 mL/kg/day), culture-proven sepsis, necrotizing enterocolitis (NEC), death, growth, cholestasis, peak alkaline phosphatase activity (AP), and incidence of feeding intolerance. The comparison group will be a matched group of infants (2 historical controls for each enrolled infant) cared for between 2006-2009. Overall comparisons will also be made between infants from 2006-2009 and the current cohort.