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100多万儿童患者需要肠内营养(EN)。 新生儿重症监护病房(NICU)，提供营养对于确保适当的生长和 发展发生了。虽然EN是救命的，但喂养管(FTs)近年来的创新有限， 尽管它们可能是并发症的来源。今天，FTs被盲目地放置在NICU的床边。 FT错位进入十二指肠、食道和肺部与并发症有关，可导致 长时间住院、发病率，以及在极少数情况下的死亡率。每个NICU都依赖于多种方法的组合 用于位置确认，包括FT插入长度、听诊、二氧化碳造影术和吸入 胃残留物。每种方法都有局限性，导致总体错置率较高(报告为4%-59% 文学)。因此，NICU迫切需要一种能够提供安全导航和 胃放置的循证确认。EN管理也是一个核心和普遍的优先事项 新生儿科医生。许多医院采用了标准化的喂养方案，但个性化的营养 对每个婴儿的特定需求进行管理可能会改善发育和总体结果。而当 适当推进饲料是当务之急，在避免喂食的同时实现这一点是一个微妙的平衡 不容忍(FI)及其并发症。因此，关于婴儿变化的实时、特定的反馈 消化状态可以在早期检测FI的情况下最大限度地提供营养。为了满足对下一个的需求- 一代FT，TheraNova开发了Gravitas系统，这是一种智能FT，提供：(1)基于证据的 指导和验证胃放置的方法和(2)指导营养的唯一胃状态指标 基于胃内容物自动跟踪的管理。重力系统由(1)一个FT和 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。在我们的 第一阶段的工作，我们确认了在临床前对FT的解剖位置进行准确分类的能力 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 第二阶段的建议是验证NICU患者的Gravitas系统。首先，我们将进行一次观测 在NICU进行研究，收集数据以优化我们的FT布局算法(目标1)。第二，使用 优化的算法，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、盲目放置(目标2)。第三，在这两项研究中，在FT插入之后和整个过程中 在管理过程中，我们将持续记录胃内容物，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态的实时数据(目标3)。成功完成 这项拟议的工作将支持重力系统的510(K)清除，以指导和确认准确的FT 放置在新生儿体内。关于胃状态跟踪的数据(AIM 3)还将使后续临床研究能够 验证这一新功能。

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.