Pulse Oximeter for Newborn Screening

描述(申请人提供)：先天性心脏病(CHD)是最常见的严重先天畸形，也是导致出生缺陷死亡的主要原因。根据临床实践，出院前对新生儿进行体检往往会漏掉患有严重冠心病(CCHD)的新生儿，这可能会导致死亡或长期患病。使用脉搏血氧饱和度(PO)可以通过检测本来会被遗漏的CCHD来改善临床检查。2011年9月，卫生部决定在建议的统一筛查小组中增加右手和一只脚的脉搏血氧饱和度筛查，以检测CCHD。美国各地的医院现在正在迅速实施PO筛查计划，以便所有新生儿在托儿所出院前都要进行PO筛查。然而，目前还没有用于新生儿的PO装置，许多人担心使用现有的脉搏血氧仪进行错误筛查的几率和成本很高。本项目的目标是开发一种用于新生儿筛查的脉搏血氧仪(PONS)，它具有许多优点：1)使用简单，从而减少了培训时间和成本；2)大大缩短了程序时间；3)来自多个传感器的信号质量更好；4)由于较低的假阳性率和消除了一次性传感器而降低了成本；减少了患者的痛苦。我们的目标是开发一种用于新生儿筛查的带有多个传感器的PONS原型。我们的Pons设备将滑过婴儿的手或脚，独特的算法和传感器放置的组合将在不到两分钟的时间内提供准确、可重复的SpO2读数。该设备的一次性内盖将用于防止 感染，增强信号采集，降低筛查成本。在最初的工作台测试、安全性和有效性之后，脑桥将首先在5名成年人身上进行评估，然后在5名新生儿中进行评估。 一氧化碳血氧测定仪确认。然后，我们将在新生儿身上进行一项临床有效性研究，以使用商用脉搏血氧仪将Pons读数与传统读数进行基准比较。我们将从港湾-加州大学洛杉矶分校医疗中心的托儿所招募100名新生儿。所有新生儿都将接受商业设备的脉搏血氧仪检查，并在出生24小时时接受庞氏夫妇的检查。主要的预期结果是减少使用PONS装置的总手术时间。我们还将比较以下参数-SpO2、信号质量、信号采集时间、成本和用户反馈。在这个项目的第二阶段，第一阶段的临床将用于重新设计TH设备，并进行临床试验，评估在第二阶段期间用于新生儿CCHD检测的PONS的成本效益。

DESCRIPTION (provided by applicant): Congenital heart diseases (CHD) are the most common serious congenital anomalies and the leading cause of death due to birth defects. Clinical practice relying on physical examination of the newborn before discharge from the nursery often misses newborns with critical CHD (CCHD), which can lead to death or long-term morbidities. Using pulse oximetry (PO) can improve clinical examination by detecting CCHD that would otherwise be missed. In September 2011, DHHS decided to add pulse oximetry screening in the right hand and one foot for CCHD detection to the Recommended Uniform Screening Panel. Hospitals throughout the US are now working expeditiously to implement PO screening programs so that all newborns will have PO screening prior to nursery discharge. However, there is no PO device for newborns and many are concerned about the high false screening rates and cost using current pulse oximeters. The goal of this project is to develop a pulse oximeter for newborn screening (PONS) that has many advantages: 1) simple to use thus reducing training time and cost; 2) much shorter procedure time; 3) better signal quality from multiple sensors; 4) lower cost from lower false positive rate and elimination of disposable sensors; less patient distress. We aim to develop a PONS prototype with multiple sensors for newborn screening. Our PONS device will slip over the infant's hand or foot, and a unique combination of algorithms and sensor placement will provide accurate, reproducible, SpO2 reading in less than two minutes. A single use interior cover of the device will be used to prevent infection, enhance signal acquisition, and reduce the cost of screening. After initial bench top testing, safety and efficacy, the PONS will be evaluated in 5 adults first, then in 5 newborns with co-oximetry validation. We will then conduct a clinical effectiveness study on newborns to benchmark PONS readings against conventional readings with a commercial pulse oximeter. We will recruit 100 newborns from the nursery at Harbor-UCLA Medical Center. All newborns will have pulse oximeter checks by a commercial device and the PONS at 24 hours of life. The primary expected outcome is a reduction of total procedure time with the PONS device. We will also compare the following parameters-SpO2, signal quality, time for signal acquisition, cost, and user feedback. In Phase II of this project, the Phase I clinical will be used to re-engineer th device and conduct a clinical trial evaluating the cost-effectiveness of the PONS for CCHD detection in newborns during Phase II.