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

这个子项目是许多利用资源的研究子项目之一 由NIH/NCRR资助的中心拨款提供。子项目的主要支持 而子项目的主要调查员可能是由其他来源提供的， 包括其它NIH来源。 列出的子项目总成本可能 代表子项目使用的中心基础设施的估计数量， 而不是由NCRR赠款提供给子项目或子项目工作人员的直接资金。 摘要 我们建议评估喂养腹壁缺陷（AWD）的婴儿与完全母乳蛋白的饮食相比，包括牛奶蛋白的饮食的短期影响。婴儿母亲将提供自己的母乳，并在可用时使用。其余饲料将由供体人乳组成。如果需要，将使用基于人乳的人乳强化剂（HMF）完成人乳强化。比较将基于主要终点全胃肠外营养（TPN）天数以及至完全肠内喂养（150 mL/kg/天）的天数、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、碱性磷酸酶活性峰值和喂养不耐受的发生率。对照组将是2006-2009年期间接受护理的婴儿的匹配组（每例入组婴儿有2个历史对照）。还将对2006-2009年的婴儿和目前的婴儿进行总体比较。 I. 假设 我们假设，仅喂养人乳蛋白（与牛乳蛋白相比）的AWD婴儿喂养耐受性改善（定义为至完全喂养的天数和总TPN天数），长期肠外营养并发症（如感染、TPN相关肝病和死亡）较少。 二. 具体目标 我们将进行一项病例对照、队列研究，以评估AWD婴儿使用人乳为基础的营养品的潜在短期获益。婴儿的母亲将提供自己的母乳（母亲自己的乳汁），并在可用时使用。其余饲料将由供体人乳组成。如果需要，将使用基于人乳的人乳强化剂（HMF）完成人乳强化。DHM和基于人乳的HMF将由Prolacta Biosciences，Inc.提供。将结果与方案H-23634的历史对照进行比较。 比较将基于主要终点全胃肠外营养（TPN）天数以及至完全肠内喂养（150 mL/kg/天）的天数、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、碱性磷酸酶活性峰值（AP）和喂养不耐受的发生率。对照组将是2006-2009年期间接受护理的匹配婴儿组（每名入组婴儿有2个历史对照）。还将对2006-2009年的婴儿和目前的婴儿进行总体比较。

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.