Optical Tomography for Diagnosis of NEC

描述（由申请人提供）： 本I期研究探讨了动态近红外光学断层扫描（DYNOT）技术可用作一种准确、无创工具来评估新生儿坏死性小肠结肠炎（NEC）风险患者小肠组织灌注的可行性。NEC是一种疾病过程，主要影响开始喂养后一周到十天的早产儿。NEC的死亡率为25%，是新生儿最常见的外科急症。保守的医疗管理允许60-80%的NEC患者自发消退。然而，其余患者将迅速恶化，临床病程恶化，需要手术干预。由于90%有NEC风险的患者是需要新生儿ICU管理的早产儿，比任何其他患者群体都多，因此外科医生必须非常小心，不要对将消退的患者进行手术，而对不会消退的患者尽早进行手术。 实验计划要求对四个具体目标进行评估，并涉及在新生儿ICU环境中管理的受试者。第一个目标是针对实现技术开发和增强努力，其目标是产生更鲁棒的数值方法，并设计具有新生儿腹部成像头的近红外光学断层扫描装置。补充这一努力将是实验室研究，旨在确定的保真度，复杂的生理信号可以成功地从重建的图像数据中提取。在优化数据收集硬件和数值方法后，我们计划进行一项动物研究，目的是将小肠缺血的光学断层扫描指标与仔猪的疾病分期相关联。这些研究旨在评估通过定量和定性成像可以阐明NEC引起的肠缺血程度的假设。从那里将进行临床研究，旨在将受损小肠组织灌注的光学标记与疾病分期和手术必要性相关联。这些研究旨在评估以下假设：通过定量和定性成像，可以在早期区分两个新生儿患者群体，从而为治疗NEC患者提供精确的手术时机。如果成功，计划中的研究预计将确定一系列基于DYNOT框架的技术解决方案，这些解决方案适用于新生儿ICU环境。从长远来看，预计所开发的技术将为NEC婴儿的小肠灌注的评估和管理提供更灵敏和更具体的方法。

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.