A Noninvasive Portable Device to Evaluate Feeding Problems in Infants

描述(由申请人提供)：喂养问题是新生儿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试管喂养。难治性喂养问题极大地增加了保健费用。在没有任何局部神经系统症状的情况下，新生儿功能障碍的吸吮与24个月大时明显的发育迟缓有关。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、准确的诊断将对这些婴儿有很大帮助，因为他们将在更小的年龄接受最适当的治疗。我们描述了我们开发的一种新的设备(Oroeter)和数据分析系统(Suck Editor)，用于量化营养吸吮行为，以及用于测试正常足月儿、早产儿、有喂养问题和严重疾病的婴儿的结果。我们在一小部分患有黏膜下腭裂和腭咽闭合不全的婴儿样本中检验了一个有趣的结果。我们认为，与EEG、EKG或EMG类似的婴儿哺乳的定量和永久记录，可能对补充目前用于评估婴儿出院前喂养能力的评分系统工具有价值，也可能对预测长期结果有价值，现在计划检验这一假设。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证明，Oroeter是便携式的、非侵入性的，它可以产生持久可靠的婴儿喂养过程中压力变化的记录。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有用补充。仅出于这些合理的理由，我们将努力将其迅速推向市场，但我们有理由相信，当研究更多的人口时，它将被证明能够发挥更大的作用。该提案旨在将Oroeter的产品设计改进为面向市场的模块化形式；在目标人群中的两个临床中心测试我们现有的原型；在两个临床中心进行扩大的临床试验；并最终获得足够的数据，以支持FDA批准重新设计的设备。我们将努力为Oroeter建立更多的用途。最后，我们描述了该设备的专门化扩展，具有研究潜力。这些设计将扩展和量化对吸吮、吞咽和呼吸的同时观察，并允许认真的研究人员在新的深度研究所有这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的喂养，从而改善对喂养困难婴儿的护理。对于早产儿，临床医生将使用客观测量来提高他们对这类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、减少家庭创伤并改善儿童营养。

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.