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

基本信息

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
项目类别：
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

项目摘要

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.

该副本是利用众多研究子项目之一由NIH/NCRR资助的中心赠款提供的资源。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构是对于中心，这不一定是调查员的机构。与包括牛奶蛋白在内的饮食相比，我们建议评估腹壁缺陷（AWD）的喂养婴儿的短期影响（AWD）的作用。婴儿的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。我们假设，喂养仅喂养人奶蛋白的AWD的婴儿（VS牛奶蛋白）将提高喂养耐受性（由几天的全部饲料和总TPN天数定义），并且长期肠胃外营养的并发症（例如感染，TPN相关的肝病和死亡）的并发症较少。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。婴儿的母亲将提供自己的母乳（母亲的牛奶，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。