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性异常，也是出生缺陷导致死亡的主要原因。临床实践依赖于新生儿出院前的体格检查，往往会遗漏危重型冠心病（CCHD）新生儿，这可能导致死亡或长期发病。使用脉搏血氧仪（PO）可以通过检测CCHD来改善临床检查。2011年9月，DHHS决定在推荐统一筛查小组中增加右手和一只脚的脉搏血氧仪筛查以检测CCHD。美国各地的医院正在迅速实施PO筛查计划，以便所有新生儿在出院前都能进行PO筛查。然而，目前还没有针对新生儿的PO设备，许多人担心目前使用的脉搏血氧仪的高假筛查率和成本。该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，从而减少培训时间和成本；2)更短的程序时间；3)多传感器信号质量更好；4)低误报率和消除一次性传感器，降低成本；减少病人的痛苦。我们的目标是开发一个具有多个传感器的PONS原型，用于新生儿筛查。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组合将在不到两分钟内提供准确，可重复的SpO2读数。一次性使用的设备内盖将用于防止

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.