Active Bottle for Home Care of Dysphagic Infants - Phase II

描述(申请人提供)：患有先天性心脏病的早产儿和足月儿通常会出现神经性吞咽困难，这是一种危及生命的疾病，其特征是在母乳和奶瓶喂养过程中吞咽和呼吸难以协调，导致体重无法增加，并由于液体进入肺部而增加肺炎或死亡的风险。 在第一阶段，Infscitex成功地设计和制造了一个计算机控制的奶瓶喂养系统原型，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稠度的液体。 第二阶段在活性奶瓶的设计和性能方面取得了几项重大进展，这些进展来自第一阶段的台架测试和戈德菲尔德博士正在进行的早产儿吞咽研究。用于神经源性吞咽困难婴儿的活性瓶子在第二阶段通过临床试验进行评估，该临床试验包括分配稀液或稠液。同时，活性奶瓶正朝着商业化的家庭护理产品迈进。 在整个项目过程中，Infvocitex的工程团队与波士顿儿童医院和贝丝以色列女执事医疗中心的临床团队密切合作，将确保活性瓶子的临床试验取得成功。积极的临床结果，以及活动奶瓶朝着更符合人体工程学、更便宜的家庭护理系统的演变，将使因神经源性言语障碍导致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展，并加速神经源性吞咽困难婴儿的NICU出院，降低NICU成本，使婴儿更早回家。 公共卫生相关性胎龄不足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过程中也更有可能出现吞咽和其他协调问题。由神经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，最终在出院后的长期家庭护理期间，患有神经源性吞咽困难的婴儿可能需要一种喂养方案，以控制正在喂给他们的液体的性质。这项研究旨在开发一种计算机控制的母乳输送系统，该系统将1)鼓励和维持神经源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展，3)加速神经源性吞咽困难婴儿的NICU出院，降低NICU费用，并使婴儿更早回家。

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.