A Novel Orogastric/Nasogastric Feeding Tube for Optimizing Nutritional Administration in the Neonatal Intensive Care Unit Population

用于优化新生儿重症监护病房人群营养管理的新型口胃/鼻胃饲管

• 批准号: 10437792
• 负责人: Daniel Rogers Burnett
• 金额: $ 57.58万
• 依托单位: THERANOVA, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10437792
• 关键词: Adopted; Adverse event; Algorithms; Anatomy; Auscultation; Blinded; Bottle feeding; Breast Feeding; Calories; Capnography; Carbon Dioxide; Clinical; Clinical Research; Cognitive; Data; Detection; Development; Devices; Duodenum; Early Diagnosis; Ensure; Enteral Feeding; Enteral Nutrition; Equilibrium; Esophagus; Feedback; Feeds; Future; Gastric Feeding Tubes; Goals; Growth; Growth and Development function; Hospitals; Impairment; Infant; Infant Development; Lead; Length; Length of Stay; Life; Link; Literature; Location; Lung; Measures; Methods; Modeling; Monitor; Morbidity - disease rate; Navigation System; Neonatal Intensive Care Units; Nurses; Nutrient; Nutrition management; Nutritional; Observational Study; Outcome; Patients; Phase; Polyurethanes; Population; Pre-Clinical Model; Procedures; Protocols documentation; Randomized; Reporting; Residual state; Savings; Source; Specificity; Standardization; Stomach; Stomach Content; System; Techniques; Temperature; Time; Training; Weight; Weight Gain; Work; base; blind; electric impedance; evidence base; feeding; improved; innovation; meetings; mortality; nasogastric feeding; neonate; next generation; novel; nutrition; pediatric patients; porcine model; respiratory; sensor; standard of care

Abstract Annually, more than one million pediatric patients require enteral nutrition (EN) in the U.S. For patients in the neonatal intensive care unit (NICU), providing nutrition is especially critical to ensuring that proper growth and development occur. While EN is life-saving, feeding tubes (FTs) have seen limited innovation in recent years, even though they can be a source of complications. Today, FTs are placed blindly at the bedside in the NICU. FT misplacement into the duodenum, esophagus, and lungs is associated with complications that can lead to prolonged hospital stays, morbidity, and, in rare cases, mortality. Each NICU relies on a combination of methods for placement confirmation, which include FT insertion length, auscultation, capnography, and aspiration of gastric residuals. Each method has limitations, resulting in high misplacement rate overall (4-59% reported in the literature). Thus, there is an urgent need in the NICU for a smart FT that can provide safe navigation and evidence-based confirmation of gastric placement. EN management is also a central and ubiquitous priority for neonatologists. Many hospitals have adopted standardized feeding protocols, but personalizing nutrition management to each infant’s specific needs may improve development and overall outcomes. While appropriately advancing feeds is a priority, there is a delicate balance to achieve this while avoiding feeding intolerance (FI) and its complications. Accordingly, real-time, specific feedback regarding changes in infant digestive status may enable maximized nutrient delivery with early detection of FI. To meet the need for a next- generation FT, TheraNova has developed the Gravitas System, a smart FT that provides: (1) an evidence-based approach to guide and verify gastric placement and (2) a unique gastric status metric to guide nutrition management based on automated tracking of stomach contents. The Gravitas System consists of (1) an FT with embedded sensors and (2) a monitor which consists of an electronic controller and user-interface display. In our Phase I work, we confirmed the ability to accurately classify the anatomic location of the FT in a pre-clinical model and to measure the concentration of stomach contents in a bench-top model. The overall goal of this Phase II proposal is to validate the Gravitas System in NICU patients. First, we will conduct an observational study in the NICU to collect data for optimization of our FT placement algorithm (Aim 1). Second, using the optimized algorithm, we will conduct a pivotal study in the NICU to validate the accuracy of Gravitas FT placement vs. standard, blind placement (Aim 2). Third, in both of these studies, after FT insertion and throughout EN management, we will continuously record stomach contents to develop our gastric status algorithm for providing real-time data to clinicians regarding the patient’s digestive status (Aim 3). Successful completion of this proposed effort will support 510(k) clearance of the Gravitas System for guiding and confirming accurate FT placement in neonates. Data on gastric status tracking (Aim 3) will also enable a follow-on clinical study to validate this novel feature.

抽象的 每年，超过一百万的儿科患者在美国需要肠内营养（EN）。 新生儿重症监护病房（NICU）提供营养对于确保适当的增长和 发展发生。尽管EN正在挽救生命，但近年来的喂食管（FT）的创新有限，但 即使它们可能是并发症的根源。如今，FTS盲目地放在NICU的床边。 ft放置在十二指肠，食道和肺部与可能导致的并发症有关 长时间住院，发病率，在极少数情况下死亡。每个NICU都依赖于方法的组合 用于放置确认，其中包括ft插入长度，听诊，胶囊和抽吸 胃残差。每种方法都有局限性的局限 文献）。这就是NICU迫切需要智能FT，可以提供安全的导航和 基于证据的胃放置确认。 en管理也是一个核心和无处不在的优先事项 新生儿学家。许多医院已经采用了标准化的喂养方案，但是个性化营养 每个婴儿的特定需求的管理可能会改善发展和整体成果。尽管 适当前进的饲料是优先的，在避免进食的同时，有一个微妙的平衡可以实现这一目标 intlerance（FI）及其并发症。根据实时，有关婴儿变化的具体反馈 消化状态可以通过FI的早期检测到最大的营养递送。满足下一步的需求 Theranova一代FT已开发了Gravitas System，这是一个提供的智能FT：（1）基于证据的 指导和验证胃位置的方法以及（2）独特的胃状态指标来指导营养 基于压力内容自动跟踪的管理。引力系统由（1）ft组成 嵌入式传感器和（2）由电子控制器和用户界面显示组成的监视器。在我们的 第一阶段的工作，我们确认能够准确地对FT进行准确分类的能力 模型并测量台式模型中摊位含量的浓度。总体目标 第二阶段的建议是验证NICU患者的重力系统。首先，我们将进行观察 在NICU中研究以收集数据以优化我们的FT放置算法（AIM 1）。第二，使用 优化的算法，我们将在NICU中进行一项关键研究，以验证Gravitas ft的准确性 位置与标准，盲位（AIM 2）。第三，在这两项研究中，英尺插入和整个整个 管理层，我们将继续记录胃内容物，以开发我们的胃状态算法 向临床医生提供有关患者消化状况的实时数据（AIM 3）。成功完成 这项提出的努力将支持重力系统的510（k）清除，以指导和确认准确的ft 放置在新生儿中。有关胃状态跟踪的数据（AIM 3）还将使后续临床研究能够 验证这个新颖的功能。