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

• 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
• 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

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（由申请方提供）：患有先天性心脏病的早产儿和足月儿通常会发生神经性吞咽困难，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，导致体重无法增加，并因将液体吸入肺部而增加肺炎或死亡的风险。 在第一阶段，Infoscitex成功地设计和建造了一个计算机控制的奶瓶喂养系统的原型，用于根据吸吮和呼吸传感器信号向吞咽困难的婴儿分配稀稠度或花蜜粘稠的液体。 第二阶段在第一阶段的实验室测试和戈德菲尔德博士对早产儿吞咽的持续研究中，在活性奶瓶的设计和功能方面取得了几项重大进展。在第二阶段，通过临床试验（包括分配稀或稠液体的测试）对用于神经性吞咽困难婴儿的Active Bottle进行评价。同时，Active Bottle正朝着商业家庭护理产品的方向发展。 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，沿着Active Bottle向更符合人体工程学、更便宜的家庭护理系统的发展，将使患有神经性吞咽困难引起的喂养问题的婴儿获得更安全、更有效的喂养方式，同时减少吸入性肺炎的发生，并加速患有神经性吞咽困难的婴儿的NICU出院，降低NICU成本，并使婴儿更快地回家与家人团聚。 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，比健康足月儿有更高的脑损伤风险。这两组婴儿在奶瓶喂养期间也更有可能遇到吞咽和其他协调问题。由于神经系统异常引起的吞咽障碍称为神经源性吞咽困难。在NICU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，该方案可以控制喂养给他们的液体的性质。本研究旨在开发一种计算机控制的牛奶输送系统，该系统将1）鼓励和维持神经性吞咽困难婴儿的正确口服喂养行为，2）减少吸入性肺炎的发生，3）加速神经性吞咽困难婴儿的NICU出院，降低NICU成本，并使婴儿更快地回家与家人团聚。