Active Bottle for Preterm Infant Oral Feeding

用于早产儿口服喂养的活性奶瓶

基本信息

批准号：
7122332
负责人：
JAMES Hunter GOLDIE
金额：
$ 59.94万
依托单位：
INFOSCITEX CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2005
资助国家：
美国
起止时间：
2005-09-16 至 2008-12-31
项目状态：
已结题

项目摘要

DESCRIPTION (provided by applicant): Of approximately 4 million live births in the U.S. in year 2000, 11.6 percent or about 471,000 infants were born less than 37 weeks gestation (Martin et al). Preterm infants may spend days or weeks in a neonatal intensive care unit (NICU), where they are nutritionally supported by nasogastric feeding tube, until they are capable of oral feeding by means of sucking and swallowing and can digest human milk or formula (Schanler & Lau). For otherwise healthy preterm infants, oral feeding difficulty is the single most important determinant of prolonged stays in intensive care (Eichenwald et al). Serious health consequences can result from persistent oral feeding problems, including malnutrition and impaired intellectual growth (Jones, Morgan & Shelton). Moreover, it is estimated that in the U.S., the cost of neonatal intensive care ranges between 50,000 and 100,000 dollars per patient (Zupancic et al). A reduction in number of NICU days associated with oral feeding difficulty could substantially reduce this cost and the risk of feeding-related health problems. The Phase II will undertake a clinical research program to evaluate both safety and proof-of-concept of a computer-controlled active bottle milk delivery system developed and tested in the laboratory during the Phase I. This system is designed to promote coordination of breathing with sucking and swallowing and to reduce the number of days that preterm infants remain in intensive care. Engineers at Infoscitex will provide the necessary active bottle systems, including bottles, electronics and control, and disposable components to conduct the clinical research at Children's Hospital Boston (CHB) and Beth Israel Deaconess Medical Center (BIDMC). Subjects will be 32 infants receiving care in the Neonatal Intensive Care Units (NICUs) at CHB and BIDMC, who are 32 to 34 weeks post conceptional age at the first test and are healthy except for their early birth. In addition, the Phase II project team will work with caregivers to conduct a human factors evaluation of the active bottle design.

描述（由申请人提供）： 2000 年，美国大约有 400 万活产婴儿，其中 11.6%（即大约 471,000 名婴儿）出生时间不足 37 周（Martin 等人）。早产儿可能会在新生儿重症监护病房 (NICU) 中度过数天或数周，通过鼻饲管获得营养支持，直到他们能够通过吸吮和吞咽进行口腔喂养，并能够消化母乳或配方奶（Schanler 和刘）。对于健康的早产儿来说，经口喂养困难是延长重症监护时间的最重要的决定因素（Eichenwald 等）。持续的口腔喂养问题可能会导致严重的健康后果，包括营养不良和智力发育受损（Jones、Morgan 和 Shelton）。此外，据估计，在美国，每位患者的新生儿重症监护费用在 50,000 至 100,000 美元之间（Zupancic 等）。减少与经口喂养困难相关的新生儿重症监护室天数可以大大降低这种成本以及与喂养相关的健康问题的风险。第二阶段将开展一项临床研究计划，以评估第一阶段在实验室开发和测试的计算机控制主动瓶装牛奶输送系统的安全性和概念验证。该系统旨在促进呼吸与呼吸的协调。吸吮和吞咽，并减少早产儿在重症监护室的天数。 Infoscitex 的工程师将提供必要的主动瓶系统，包括瓶子、电子设备和控制装置以及一次性组件，以便在波士顿儿童医院 (CHB) 和贝斯以色列女执事医疗中心 (BIDMC) 进行临床研究。受试者是在 CHB 和 BIDMC 新生儿重症监护病房 (NICU) 接受护理的 32 名婴儿，他们在第一次测试时处于受孕后 32 至 34 周，除早产外均健康。此外，二期项目团队将与护理人员合作，对主动瓶设计进行人因评估。