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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 我们建议评估用纯母乳蛋白饮食与含牛奶蛋白饮食喂养腹壁缺陷（AWD）婴儿的短期效果。婴儿的母亲将提供自己的母乳，并在可用时使用。饮食的其余部分将包括捐赠的母乳。如果需要，将使用母乳强化剂 (HMF) 来完成母乳强化。比较将基于全肠外营养 (TPN) 天数以及完全肠内喂养天数 (150 mL/kg/天)、培养证实的败血症、坏死性小肠结肠炎 (NEC)、死亡、生长、胆汁淤积等主要终点、峰值碱性磷酸酶活性以及喂养不耐受的发生率。对照组将是 2006 年至 2009 年期间照顾的匹配婴儿组（每个登记婴儿有 2 个历史对照）。还将对 2006 年至 2009 年的婴儿与当前队列的婴儿进行总体比较。 我们假设，仅喂养母乳蛋白（与牛奶蛋白）的患有 AWD 的婴儿将具有改善的喂养耐受性（定义为完全喂养天数和总 TPN 天数），并且长期肠外营养的并发症较少（例如感染、TPN 相关肝病和死亡）。 我们将进行一项病例对照队列研究，以评估使用母乳营养对 AWD 婴儿的潜在短期益处。婴儿的母亲将提供自己的母乳（妈妈自己的乳汁，MOM），如有可用，将使用母乳。饮食的其余部分将包括捐赠的母乳。如果需要，将使用母乳强化剂 (HMF) 来完成母乳强化。 DHM 和基于母乳的 HMF 将由 Prolacta Biosciences, Inc. 提供。结果将与方案 H-23634 的历史对照进行比较。 比较将基于全肠外营养 (TPN) 天数以及完全肠内喂养天数 (150 mL/kg/天)、培养证实的败血症、坏死性小肠结肠炎 (NEC)、死亡、生长、胆汁淤积等主要终点、峰值碱性磷酸酶活性（AP）以及喂养不耐受的发生率。对照组将是 2006 年至 2009 年期间照顾的匹配婴儿组（每个登记婴儿有 2 个历史对照）。还将对 2006 年至 2009 年的婴儿与当前队列的婴儿进行总体比较。