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

摘要 在美国，每年有超过一百万的儿科患者需要肠内营养（EN）。 新生儿重症监护室（NICU），提供营养是特别重要的，以确保适当的增长和 发展发生。虽然EN可以挽救生命，但近年来饲管（FT）的创新有限， 即使它们可能是并发症的来源。今天，FT被盲目地放置在NICU的床边。 FT错位进入十二指肠、食管和肺与并发症相关，可导致 延长住院时间，发病率，以及在极少数情况下的死亡率。每个新生儿重症监护室都依赖于一种方法的组合 用于放置确认，包括FT插入长度、听诊、二氧化碳描记和抽吸 胃残留物每种方法都有局限性，导致整体错位率较高（2011年报告为4-59%）。 文学）。因此，NICU迫切需要一种智能FT，它可以提供安全的导航， 胃放置的循证确认。EN管理也是一个中心和普遍存在的优先事项， 医学家。许多医院采用了标准化的喂养方案，但个性化的营养 对每一个婴儿的特殊需要进行管理可以改善发展和总体结果。而 适当地推进饲料是一个优先事项，有一个微妙的平衡，以实现这一点，同时避免喂养 不耐受（FI）及其并发症。因此，关于婴儿的变化的实时、具体的反馈可以被实现。 消化状态可以通过早期检测FI实现最大化的营养输送。为了满足下一个- TheraNova开发了Gravitas系统，这是一种智能FT，可提供：（1）基于证据的 指导和验证胃放置的方法和（2）指导营养的独特胃状态指标 基于胃内容物的自动跟踪的管理。Gravitas系统包括（1）FT， 嵌入式传感器和（2）由电子控制器和用户界面显示器组成的监视器。在我们 在第一阶段的工作中，我们证实了在临床前检查中准确分类FT解剖位置的能力。 模型，并在台式模型中测量胃内容物的浓度。这个项目的总体目标是 II期提案旨在确认Gravitas系统在NICU患者中的应用。首先，我们将进行一次观察 在NICU中进行研究，以收集数据，用于优化我们的FT放置算法（目标1）。第二，使用 优化算法，我们将在NICU进行关键研究，以验证Gravitas FT的准确性 放置与标准盲放置（目标2）。第三，在这两项研究中，在FT插入后和整个过程中， EN管理，我们将持续记录胃内容物，以制定胃状态算法， 向临床医生提供关于患者消化状态的实时数据（目标3）。成功完成 这项提议的工作将支持重力系统的510（k）许可，以指导和确认准确的FT 在新生儿中放置。关于胃状态跟踪的数据（目标3）也将使后续临床研究成为可能， 验证这个新功能。

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.