A RANDOMIZED, CONTROLLED TRIAL OF NUTRITIONAL SUPPORT IN PEDIATRIC STEM CELL TRS

儿科干细胞 TRS 营养支持的随机对照试验

• 批准号: 7951546
• 负责人: Robert s Venick
• 金额: $ 0.13万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951546
• 关键词: Affect; Body Composition; Body fat; Calories; Child; Childhood; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Controlled Clinical Trials; Dietary intake; Double-Blind Method; Dual-Energy X-Ray Absorptiometry; Energy Intake; Energy Metabolism; Funding; Grant; Indirect Calorimetry; Institution; Insulin Resistance; Lead; Measures; Methods; Mucositis; Nutritional; Nutritional Support; Oral; Parenteral Nutrition; Patients; Proteins; Protocols documentation; Randomized; Randomized Controlled Trials; Research; Research Personnel; Resources; Rest; Source; Stem cell transplant; Stem cells; Traumeel S; Treatment Protocols; United States National Institutes of Health; gastrointestinal; glycemic control; standard of care

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. Children undergoing stem cell transplantation (SCT) often require parenteral nutrition to provide adequate calories and protein due to severe mucositis and other gastrointestinal complications of the preparative regimen (1). Accurate provision of energy may reduce complications related to overfeeding (2) or underfeeding (3). We hypothesize that changes in body composition during SCT affect resting energy expenditure (REE), and that the standard approach to nutritional management of these patients may lead to overfeeding. We propose a randomized controlled trial to compare the nutritional effects of the standard method of nutritional support with an approach in which energy intake provided matches the resting energy expenditure as measured by indirect calorimetry. Specific Aims: To conduct a randomized, double-blinded controlled clinical trial among pediatric SCT patients comparing two methods of nutritional support: 1) standard of care (the provision of 130-150% of estimated basal energy needs via parenteral nutrition), and 2) an experimental protocol in which energy intake is titrated to match resting energy expenditure as measured by indirect calorimetry. A. Primary 1. To compare the effects of standard vs. titrated nutritional support in pediatric SCT patients on percent body fat, as measured by DXA. 2. To compare the effects of standard vs. titrated nutritional support in pediatric SCT patients on glycemic control and insulin resistance. 3. To measure serial changes in REE over the course of SCT with indirect calorimetry. 4. To correlate anticipated changes in REE with changes in body composition. B. Secondary 1.To measure resumption of oral dietary intake after SCT.

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。 接受干细胞移植（SCT）的儿童通常需要肠胃外营养，以提供足够的卡路里和蛋白质，这是由于严重的粘膜炎和制备方案的其他胃肠道并发症（1）。 精确提供能量可能会减少与过度喂养（2）或喂养不足有关的并发症（3）。 我们假设SCT期间身体成分的变化会影响静息能量消耗（REE），并且这些患者营养管理的标准方法可能导致过度喂养。 我们提出了一项随机对照试验，以将营养支持标准方法的营养效应与一种方法进行的方法进行比较，在该方法中，能量摄入提供的方法与通过间接量热法测量的静息能量相匹配。 具体目的：在小儿SCT患者中进行随机，双盲的对照临床试验，比较了两种营养支持方法：1）护理标准（提供130-150％的通过肠胃外营养估计的基础能量需求的130-150％），以及2）一种实验方案，在该方案中，能量进气可以通过滴定为静止的能量消耗，以通过Indirectriectirectriectriectriectriectriectirectriectirectriectirectirectirectirectirectirectirectirectirectirectirectirectirectirectirection。 A.主要 1。用DXA测量，比较小儿SCT患者对体内脂肪百分比的影响。 2。为了比较标准的滴定营养支持对小儿SCT患者对血糖控制和胰岛素抵抗的影响。 3。通过间接量热法测量SCT过程中REE的串行变化。 4。将REE的预期变化与身体成分的变化相关联。 B.次要 1.测量SCT后口服饮食摄入量的恢复。