Active Bottle for Preterm Infant Oral Feeding

用于早产儿口服喂养的活性奶瓶

• 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
• 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
• 来源: https://reporter.nih.gov/project-details/7122332
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; clinical research; computer assisted patient care; computer simulation; computer system design /evaluation; developmental nutrition; fluid flow; human subject; low birth weight infant human; microprocessor /microchip; milk; nutrition related tag; oral administration; oral behavior; patient monitoring device; premature infant human; pulmonary respiration; swallowing

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）： 在2000年，美国约有400万活出生中，有11.6％或约471,000名婴儿出生的妊娠不到37周（Martin等人）。早产儿可能会在新生儿重症监护病房（NICU）度过几天或几周，在那里他们得到鼻胃喂养管的营养支持，直到他们能够通过吮吸和吞咽来口服喂养，并可以消化人类牛奶或配方奶粉（Schanler＆Lau）。对于其他健康的早产儿，口服喂养困难是重症监护术长期住宿的最重要决定因素（Eichenwald等人）。持续的口服喂养问题，包括营养不良和智力增长受损（Jones，Morgan＆Shelton）可能会造成严重的健康后果。此外，据估计，在美国，新生儿重症监护的成本在每位患者50,000至100,000美元之间（Zupancic等人）。与口服喂养难度相关的NICU天数减少可以大大降低这一成本和与喂养相关的健康问题的风险。 第二阶段将采用临床研究计划，以评估在实验室中开发和测试的计算机控制的活跃奶牛输送系统的安全性和概念证明。该系统旨在促进呼吸和吞咽和吞咽的协调，并减少在强化护理中保持早产的天数。 Infoscitex的工程师将提供必要的活动瓶系统，包括瓶子，电子和控制，以及一次性组件，以在波士顿儿童医院（CHB）和Beth Israel Deaconess Medical Center（BIDMC）进行临床研究。受试者将是32名在CHB和BIDMC的新生儿重症监护病房（NICUS）接受护理的婴儿，在第一次测试时构思年龄32至34周，除早期出生外，他们还很健康。此外，第二阶段项目团队将与护理人员合作，对主动瓶设计进行人为因素评估。