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: 8356736
• 负责人: STEVEN A ABRAMS
• 金额: $ 0.08万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-12-01 至 2011-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8356736
• 关键词: Alkaline Phosphatase; Cattle; Cessation of life; Cholestasis; Clinical Research; Cohort Studies; Defect; Diet; Enrollment; Enteral Feeding; Evaluation; Feeds; Funding; Grant; Growth; Human Milk; Incidence; Infant; Infant Care; Infection; Liver diseases; Matched Group; Milk; Milk Proteins; Mothers; National Center for Research Resources; Necrotizing Enterocolitis; Outcome; Parenteral Nutrition; Principal Investigator; Protocols documentation; Research; Research Infrastructure; Resources; Sepsis; Source; Total Parenteral Nutrition; United States National Institutes of Health; abdominal wall; base; case control; cohort; comparison group; cost; 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. 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.

该副本是利用资源的众多研究子项目之一 由NIH/NCRR资助的中心赠款提供。对该子弹的主要支持 而且，副投影的主要研究员可能是其他来源提供的 包括其他NIH来源。 列出的总费用可能 代表subproject使用的中心基础架构的估计量， NCRR赠款不直接向子弹或副本人员提供的直接资金。 抽象的 我们建议与包括牛奶蛋白在内的饮食相比，评估腹壁缺陷（AWD）的喂养婴儿的短期影响（AWD）的短期影响。婴儿母亲将提供自己的母乳，可在使用时使用。其余的饮食将由供体牛奶组成。如果需要，将使用基于人乳的人牛奶堡垒（HMF）来实现人力牛奶的强化。比较将基于全肠外营养（TPN）的主要终点，以及全肠内喂养的天数（150 mL/kg/day），培养物 - 预处理败血症，坏死性小肠结肠炎（NEC），死亡，生长，生长，胆汁疾病，胆汁疾病，胆碱，碱性磷酸酶活性峰值和喂养性无效性。比较组将是一组匹配的婴儿（每个注册婴儿的2个历史对照），在2006 - 2009年之间进行了匹配。从2006 - 2009年的婴儿和当前队列之间也将进行总体比较。 I.假设 我们假设，喂养仅喂养的AWD的婴儿（VS牛奶蛋白）将具有提高的喂养耐受性（由几天的全部饲料和TPN天数定义），并且长期肠胃外营养的并发症（例如感染，TPN相关肝病和死亡）的并发症较少。 ii。 具体目标 我们将进行一项案例控制，队列研究，以评估对患有AWD的婴儿使用基于人奶的营养的潜在短期益处。婴儿母亲将提供自己的母乳（母亲自己的牛奶，妈妈），可在使用时使用。其余的饮食将由供体牛奶组成。如果需要，将使用基于人乳的人牛奶堡垒（HMF）来实现人力牛奶的强化。 DHM和人乳基的HMF将由Prolacta Biosciences，Inc。提供的结果与H-23634方案的历史对照进行比较。 比较将基于全肠外营养（TPN）的主要终点以及全肠内喂养的天数（150 mL/kg/day），培养型败血症，坏死性小肠结肠炎（NEC），死亡，生长，生长，胆汁疾病，胆汁疾病，胆汁疾病，碱性磷酸酶活性（AP）和浓度的含量。比较组将是一组匹配的婴儿（每个注册婴儿的2个历史对照），在2006 - 2009年之间进行了匹配。从2006 - 2009年的婴儿和当前队列之间也将进行总体比较。