A Noninvasive Portable Device to Evaluate Feeding Problems in Infants

描述（由申请人提供）：喂养问题是新生神经损伤的常见先兆，也是婴儿从医院托儿所过渡到出院的主要障碍。严重的问题往往需要反复住院和管饲。难治性喂养问题是造成保健费用高昂的主要原因。在没有任何局部神经症状的情况下，新生儿吸吮功能障碍与24个月大时明显的发育迟缓相关。据估计，57-92%的脑损伤婴儿有吞咽困难，长期营养不良、生长障碍和死亡率较高的风险较高。 早期、准确的诊断对这些婴儿有很大帮助，因为他们会在更早的年龄接受最适当的治疗。 我们描述了一种新的设备（Orometer）和数据分析系统（吸吮编辑器），我们已经开发出量化营养吸吮行为和结果时，它被用来测试正常的足月婴儿，早产儿，婴儿喂养问题和严重疾病。我们研究了一个有趣的结果，在一个小样本的婴儿粘膜下腭裂和腭咽功能不全。 我们假设，婴儿吸吮的定量和永久性记录与EEG，EKG或EMG相当，可能有助于补充目前用于评估婴儿出院前喂养能力的评分系统工具，并可能有助于预测长期结果，现在计划验证这一假设。 在我们的第一阶段和第二阶段SBIR赠款期间进行的工作已经确定，Orometer是便携式的，非侵入性的，并且它可以产生婴儿喂养期间发生的压力变化的持久和可靠的记录。它已经被证明是记录口腔运动行为的一个有价值的工具;它产生的记录是对主观喂养观察的一个有用的补充。我们将奋进将其迅速推向市场，仅仅是因为这些合理的原因，但我们有理由相信，当对更大的人群进行研究时，它将被证明具有更大的能力。 该提案旨在将Orometer的产品设计改进为可上市的模块化形式;在两个临床中心的目标人群中测试我们现有的原型;在两个临床中心进行扩展临床试验;并最终获得足够的数据来支持FDA批准重新设计的设备。我们将奋进建立Orometer的其他用途。最后，我们描述了专门的扩展，这个设备具有研究潜力。这些设计将扩展和量化同时观察吸吮，吞咽和呼吸，并允许认真的研究人员在新的深度研究所有三个重要功能的协调。 公共卫生相关性：这项研究很重要，因为它将产生一种产品，帮助临床医生更准确地观察婴儿喂养，从而改善对喂养困难的幼儿的护理。对于早产儿，临床医生将使用客观的测量来提高他们对这些婴儿何时可以在家庭环境中茁壮成长的理解，从而缩短住院时间，降低成本，减少家庭创伤，改善儿童营养。

DESCRIPTION (provided by applicant): Feeding problems are a frequent harbinger of nascent neurological damage and are a major obstacle in transitioning infants from hospital nursery to discharge. Severe problems often require repeated hospitalization and tube feeding. Refractory feeding problems contribute significantly to the high cost of health care. Dysfunctional sucking in the newborn, in the absence of any focal neurological symptoms, is known to correlate with developmental delay evident at 24 months of age. It is estimated that 57-92% of infants with brain damage have dysphagia and are at higher risk of long-term malnutrition, growth failure and higher mortality rates. Early, accurate diagnosis would be of great help to these infants, as they would receive the most appropriate treatment at an earlier age. We describe a novel device (an Orometer) and data analytical system (Suck Editor) that we have developed to quantify nutritive sucking behavior and the results when it is used to test normal full-term infants, premature infants, infants with feeding problems and serious illness. We examine an intriguing result in a small sample of infants with submucosal cleft palate and velopharyngeal insufficiency. We posited that a quantitative and permanent record of infant sucking comparable to EEG, EKG or EMG might be of value in supplementing the current scoring systems tools used to assess an infant's feeding competence prior to discharge and perhaps of value for predicting long-term outcome, and now plan to test that hypothesis. Work conducted during our Phase I and Phase II SBIR grants has established that the Orometer is portable, noninvasive, and that it produces durable and reliable records of pressure changes which occur during infant feeding. It has already been proved to be a valuable tool for documenting oral-motor behavior; the records it produces are a useful supplement to subjective feeding observations. We will endeavor to bring it to market quickly for these sound reasons alone, but we have reason to believe that when larger populations are studied, it will prove capable of far more. This proposal seeks to refine the product design of the Orometer to a market-ready modular form; test our existing prototypes in two clinical centers in targeted populations-of-interest; perform expanded clinical trials in two clinical centers; and finally obtain sufficient data to support FDA approval for the re-engineered device. We will endeavor to establish additional uses for the Orometer. Finally, we describe specialized extensions of this device which hold research potential. These designs will extend and quantify simultaneous observations of suck, swallow and breathing, and allow serious researchers to study the coordination of all three vital functions in new depth. PUBLIC HEALTH RELEVANCE: This research is important because it will produce a product to help clinicians observe infant feeding more accurately, leading to improved care for young infants with feeding difficulties. For premature infants, clinicians will use objective measurement to improve their understanding of when such infants can thrive in a home environment, leading to shorter hospital stays, lower costs, less trauma for families, and improved childhood nutrition.