Optical Tomography for Diagnosis of NEC

描述(由申请人提供)： 这项第一阶段的研究探讨了动态近红外光学断层扫描(DYNOT)技术作为一种准确的、无创的工具来评估有坏死性小肠结肠炎(NEC)风险的新生儿患者的小肠组织灌注的可行性。NEC是一种疾病过程，主要影响早产儿在开始喂养后一周至十天。NEC的死亡率为25%，是新生儿最常见的外科急症。保守的医疗治疗使60%-80%的NEC患者能够自发痊愈。然而，剩下的患者将迅速恶化，临床病程恶化，需要手术干预。由于90%的NEC风险患者是需要新生儿ICU管理的早产儿，比任何其他患者群体都要多，外科医生必须非常小心，不要对将会消失的患者进行手术，而对不会恢复的患者要尽可能早地进行手术。 该实验计划要求评估四个具体目标，并涉及在新生儿ICU环境中管理的受试者。第一个目标是进行技术开发和改进工作，目的是产生更可靠的数值方法，并设计一种具有新生儿腹部成像头的近红外光学层析成像设备。作为这一努力的补充，实验室研究将旨在确定从重建的图像数据中成功提取复杂生理信号的保真度。随着数据收集硬件和数值方法的优化，我们计划进行一项动物研究，目的是将肠缺血的光学断层扫描指标与仔猪的疾病分期联系起来。这些研究旨在评估这样一种假设，即通过定量和定性成像可以阐明NEC引起的肠缺血的程度。从那时起，将进行一项临床研究，旨在将受损小肠组织灌注的光学标记物与疾病分期和手术必要性相关联。这些研究旨在评估这样一种假设，即通过定量和定性成像，可以在早期区分这两类新生儿患者，从而为治疗NEC患者提供固有的准确手术时机。如果成功，预计计划中的研究将根据DYNOT的框架确定一系列适用于新生儿ICU环境的技术解决方案。从长远来看，预计开发的技术将为评估和管理患有NEC的婴儿的小肠灌流提供一种更敏感和更具体的方法。

DESCRIPTION (provided by applicant): This Phase I study explores the feasibility by which the technique of dynamic near-infrared optical tomography (DYNOT) can be employed as an accurate, noninvasive tool to assess tissue perfusion of small bowel in neonatal patients at risk for Necrotizing Enterocolitis (NEC). NEC is a disease process that primarily affects premature infants a week to ten days after the initiation of feeding. With a 25% mortality rate, NEC is the most common surgical emergency of newborns. Conservative medical management allows for 60-80% of patients with NEC to resolve spontaneously. However the remaining patients will deteriorate rapidly with a worsening clinical course necessitating surgical intervention. Due to the fact that 90% of patients at risk for NEC are premature infants needing Neonatal- ICU management, more than any other patient population, the surgeon has to be quite careful not to operate on the patients who will resolve, while operating as early as possible on the patients who will not. The experimental plan calls for the evaluation of four specific aims and involves subjects being managed in a Neonatal-ICU environment. The first aim is directed towards implementing a technology development and enhancement effort with the goal of producing more robust numerical methods and to design a near infrared optical tomography device with a neonatal abdominal imaging head. Supplementing this effort will be laboratory studies aimed at identifying the fidelity by which complex physiological signals can be successfully extracted from reconstructed image data. Following optimization of the data collection hardware and numerical methods, we plan to undertake an animal study with the intent to correlate optical tomographic indicators of bowel ischemia to disease staging in the piglet. These studies are intended to evaluate the hypothesis that through quantitative and qualitative imaging the extent of bowel ischemia caused by NEC can be elucidated. From there a clinical study will be done aimed at correlating the optical markers of compromised small bowel tissue perfusion to disease staging and the necessity of surgery. These studies are intended to evaluate the hypothesis that through quantitative and qualitative imaging the two populations of neonatal patients can be differentiated at an early stage, allowing for the precise timing of surgery inherent in treating NEC patients. If successful, the planned studies are expected to identify a range of technology solutions, based on the framework of DYNOT, that are geared towards use in Neonatal-ICU environments. In the long term, it is anticipated that the developed technology will provide a more sensitive and specific approach for the evaluation and management of small bowel perfusion in infants with NEC.