Active Bottle for Preterm Infant Oral Feeding

2000年，在美国约400万例活产婴儿中，11.6%或约471，000例婴儿出生时妊娠不足37周（Martin等人）。早产儿可能会在新生儿重症监护室（NICU）中度过数天或数周，在那里他们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服喂养，并且可以消化母乳或配方奶粉（Schanler & Lau）。对于其他方面健康的早产儿，经口喂养困难是最重要的 长期重症监护的决定因素（Eichenwald等人）。经口进食困难的一个基本组成部分是呼吸与吸吮和吞咽的协调。 提出了一种计算机控制的主动奶瓶母乳输送系统的开发和临床评价，旨在促进呼吸与吸吮和吞咽的协调，并减少早产儿留在重症监护室的天数。持续的口服喂养问题可能导致严重的健康后果，包括营养不良和智力发育受损（Jones，Morgan &谢尔顿）。此外，据估计，在美国，新生儿重症监护的成本范围在每个患者50，000美元至100，000美元之间（Zupancic等人）。减少与经口喂养困难相关的NICU天数可以大大降低这种成本和喂养相关的风险。 健康问题 第一阶段是发展进程中合乎逻辑的第一步。它包括四个步骤：活性瓶的组装、台架测试和校准;模拟婴儿使用;通过与卫生专业人员接触评估人为因素;以及为第二阶段做准备，在第二阶段中，将对婴儿进行瓶测试。首先，构建原型并进行台架测试，以确认传感器，流量控制组件和控制器按预期工作。第二，“回放”先前记录的来自健康足月婴儿的初步研究的吮吸和呼吸波形，并且确定瓶控制器是否正确地使用 记录的信号来调节奶瓶中的牛奶流量。第三，我们进行人为因素评估的积极瓶设计，要求卫生专业人员举行和工作的原型。我们以在第二阶段期间开始婴儿测试所需的任务结束。

Of approximately 4 million live births in the United States 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.). A fundamental component of oral feeding difficulty is coordination of breathing with sucking and swallowing. The development and clinical evaluation of a computer-controlled active bottle milk delivery system is proposed, aimed at promoting coordination of breathing with sucking and swallowing, and reducing the number of days that preterm infants remain in intensive care. 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 United States, 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. Phase I represents a logical first step in the development process. It consists of four steps: assembly, bench test and calibration of the active bottle; simulation of use by human infants; evaluation of human factors through contact with health professionals; and preparation for a Phase II in which the bottle would be tested with infants. First, a prototype is built and bench-tested to confirm that the sensors, flow control components and controller are working as intended. Second, previously recorded sucking and breathing waveforms from a pilot study of healthy term infants is "played back," and it is determined if the bottle controller correctly uses the recorded signals to regulate milk flow from the bottle. Third, we conduct human factors evaluation of the active bottle design by asking health professionals to hold and work with the prototype. We conclude with tasks necessary to begin testing with infants during a Phase II.