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

腹壁缺陷婴儿使用供者母乳的评估

• 批准号: 8166750
• 负责人: STEVEN A ABRAMS
• 金额: $ 0.02万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8166750
• 关键词: Alkaline Phosphatase; Cattle; Cessation of life; Cholestasis; Cohort Studies; Computer Retrieval of Information on Scientific Projects Database; Defect; Diet; Enrollment; Enteral Feeding; Evaluation; Feeds; Funding; Grant; Growth; Human Milk; Incidence; Infant; Infant Care; Infection; Institution; Liver diseases; Matched Group; Milk; Milk Proteins; Mothers; Necrotizing Enterocolitis; Outcome; Parenteral Nutrition; Protocols documentation; Research; Research Personnel; Resources; Sepsis; Source; Total Parenteral Nutrition; United States National Institutes of Health; abdominal wall; base; case control; cohort; comparison group; feeding; fortification; improved; infant nutrition

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. 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 cow s milk protein. Infant s 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. We hypothesize that infants with AWD that are fed exclusively human milk protein (vs cow s 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). 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. Infant s mothers will provide their own breast milk (mother s 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.

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。 我们建议评价用完全人乳蛋白饮食喂养腹壁缺陷（AWD）婴儿与含牛乳蛋白饮食相比的短期效果。婴儿的母亲将提供自己的母乳，将在可用时使用。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。 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（定义为全喂养天数和总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。 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（母亲自己的母乳，母乳），将在可用时使用。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。