Active Bottle for Home Care of Dysphagic Infants - Phase II

用于吞咽困难婴儿家庭护理的主动奶瓶 - 第二阶段

基本信息

批准号：
7482655
负责人：
EUGENE C GOLDFIELD
金额：
$ 74.97万
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：
2005-06-01 至 2010-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7482655
关键词：
Aftercare Blood Boston Bottle feeding Brain Injuries Breast Breathing Caring Cessation of life Clinical Clinical Research Clinical Trials Collaborations Computer software Computers Condition Decision Making Deglutition Deglutition Disorders Development Devices Diagnosis Dysphasia Engineering Ensure Evolution Exhibits Failure Family Feeding behaviors Gestational Age Home environment Hospitals Infant Infant formula Israel Life Liquid substance Lung Medical center Milk Motor Activity Neurologic Neurologic Examination Nurses Oral Pediatric Hospitals Phase Physicians Pneumonia Premature Infant Process Progress Reports Property Protocols documentation Public Health Research Respiration Risk Safety Signal Transduction Site Small Business Funding Mechanisms Small Business Innovation Research Grant System Technology Testing Thick Time Update Week Weight Gain base care systems concept congenital heart disorder cost design ergonomics experience feeding improved patient home care programs prototype respiratory sensor sucking

项目摘要

DESCRIPTION (provided by applicant): Prematurely born infants and term infants with congenital heart disease often develop neurogenic dysphagia, a life-threatening condition characterized by difficulty in coordinating swallowing and breathing during breast and bottle feeding, resulting in a failure to gain weight and increased risk of pneumonia or death, due to taking fluid into the lungs. During Phase I, Infoscitex successfully designed and built a prototype of a computer-controlled bottle feeding system for dispensing either thin-consistency or nectar-thick fluids to dysphagic infants on the basis of sucking and respiration sensor signals. Phase II makes several major advances in the design and capabilities of the active bottle that have resulted from the Phase I bench tests and Dr. Goldfield's ongoing research into swallowing by premature infants. The Active Bottle for infants with neurogenic dysphagia is evaluated during Phase II by means of a clinical trial consisting of tests involving dispensing of thin or thick fluids. At the same time, the Active Bottle is advanced towards a commercial home-care product. Close collaboration between the engineering team at Infoscitex and the clinical teams at both Children's Hospital Boston and Beth Israel Deaconess Medical Center throughout the project, will ensure that clinical trials with the Active Bottle are successful. Positive clinical results, along with the evolution of the Active Bottle towards a more ergonomic, less expensive, home care system will allow infants with feeding problems caused by neurogenic dysphasia a safer and more effective means for feeding, while reducing development of aspiration-induced pneumonia, and hastening NICU discharge of infants with neurogenic dysphagia, reducing NICU cost and allowing infants to come home to their families sooner. PUBLIC HEALTH RELEVANCE Premature infants born less than 33 weeks gestational age, or born at term with congenital heart disease, have a higher risk of brain injury than healthy term infants. These two groups of infants are also more likely to experience swallowing and other coordination problems during bottle feedings. Swallowing disorder due to neurological abnormality is called neurogenic dysphagia. During care in the NICU, and eventually during the long term home care after hospital discharge, infants with neurogenic dysphagia may require a feeding protocol that manipulates the properties of the fluids being fed to them. This research is aimed at the development of a computer-controlled milk delivery system that would 1) encourage and maintain proper oral feeding behavior in infants with neurogenic dysphagia, 2) reduce development of aspiration-induced pneumonia, 3) hasten NICU discharge of infants with neurogenic dysphagia, reducing NICU cost, and allowing infants to come home to their families sooner.

描述（由申请人提供）：患有先天性心脏病的早产儿和足月儿经常会出现神经源性吞咽困难，这是一种危及生命的疾病，其特征是在母乳喂养和奶瓶喂养期间难以协调吞咽和呼吸，导致体重增加失败，体重增加。由于将液体吸入肺部而导致肺炎或死亡的风险。在第一阶段，Infoscitex 成功设计并构建了计算机控制奶瓶喂养系统的原型，该系统可根据吸吮和呼吸传感器信号向吞咽困难的婴儿分配稀稠或花蜜浓稠的液体。第二阶段在主动奶瓶的设计和功能方面取得了几项重大进步，这些进步是第一阶段的台架测试和 Goldfield 博士正在进行的早产儿吞咽研究的结果。用于患有神经源性吞咽困难的婴儿的活性奶瓶在第二阶段通过临床试验进行评估，该临床试验包括涉及稀薄或浓稠液体分配的测试。同时，活性瓶也向商业化家庭护理产品迈进。 Infoscitex 的工程团队与波士顿儿童医院和贝斯以色列女执事医疗中心的临床团队在整个项目中密切合作，将确保 Active Bottle 的临床试验取得成功。积极的临床结果，加上活性奶瓶向更符合人体工程学、更便宜的家庭护理系统的发展，将使因神经源性语言障碍引起的喂养问题的婴儿成为更安全、更有效的喂养方式，同时减少吸入性肺炎的发生，并加快神经源性吞咽困难婴儿从 NICU 出院，降低 NICU 费用，让婴儿更快回家与家人团聚。公共卫生相关性胎龄小于 33 周的早产儿或患有先天性心脏病的足月儿比健康足月儿的脑损伤风险更高。这两类婴儿在奶瓶喂养期间也更有可能出现吞咽和其他协调问题。由于神经系统异常而导致的吞咽障碍称为神经源性吞咽困难。在新生儿重症监护室的护理期间，以及最终在出院后的长期家庭护理期间，患有神经性吞咽困难的婴儿可能需要一种喂养方案来控制喂养给他们的液体的特性。本研究旨在开发计算机控制的输奶系统，该系统能够 1) 鼓励和维持神经源性吞咽困难婴儿的正确经口喂养行为，2) 减少吸入性肺炎的发展，3) 加速患有神经源性吞咽困难的婴儿从 NICU 出院。神经源性吞咽困难，降低新生儿重症监护病房 (NICU) 费用，并让婴儿更快回家与家人团聚。