CLINICAL TRIAL: EARLY TREATMENT OF ALS WITH NUTRITION AND NIPPV

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项涉及11个子站的先导性研究，目的是测试NIPPV和营养管理对ALS患者的疗效。6个站点将参与早期NIPPV干预，5个站点将参与营养管理干预，每个站点将招募20名患者。 NIPPV研究机构的主要目标是开发和验证提高NIPPV耐受性的策略，确定影响这种治疗方式接受的因素，并评估早期呼吸衰竭的措施。早期营养管理部门的主要目标是开发和验证确定ALS患者能量平衡的方法，这些方法将适用于营养和NIPPV的多中心III期研究。

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. This is a pilot study involving 11 sub-sites to test the efficacy with NIPPV and nutritional management in patients with ALS. Six sites will be involved with early NIPPV intervention, and five sites will be involved in nutritional management intervention, and each site will recruit 20 patients. The primary goals of the NIPPV study arm are to develop and validate strategies to improve tolerability of NIPPV, to identify factors that influence acceptance of this treatment modality, and to evaluate measures of early respiratory failure. The primary goals of the early nutrition management arm are to develop and validate methods to determine energy balance in ALS patients that will be applicable to a multicenter Phase III study of nutrition and NIPPV.