A Low-Cost Cardiac Annunciator to Reduce Stillbirths and Neonatal Deaths

描述（由申请人提供）：全世界每年有370万新生儿死亡和260万死产，其中98%发生在发展中国家。其中一些死亡是由于助产士没有认识到出生时没有反应的新生儿是活着的，可以复苏。这项提议的目标是开发和评估一种简单的仪器，称为心脏指示器，可以放置在新生儿的胸部来感知其心电图，并为每一次检测到的心跳产生声音和闪光。这样的装置可以帮助确认婴儿是否还活着，是否应该尝试复苏。它也可以用来确认在复苏过程中心率的改善。拟议的努力旨在开发包括电子、传感电极和包装在内的设备，然后在国内和印度的临床设施中评估该设备。将根据这些评估对该装置进行进一步的工程改进，如果成功，该装置可用于发展中国家更大规模的临床研究，以证明其对降低全世界婴儿死亡率的总体影响。一个由生物医学工程师、印度临床生理学家和新生儿学家组成的调查小组将确保开发的心脏指示器的设计将满足发展中国家的临床需求，并遵循良好的工程实践。

DESCRIPTION (provided by applicant): There are 3.7 million neonatal deaths and 2.6 million stillbirths in the world each year, and 98% of these occur in developing countries. Some of these deaths are the result of birth attendants not recognizing that unresponsive neonates at birth are alive and can be resuscitated. The goal of this proposed effort is to develop and evaluate a simple instrument, known as a cardiac annunciator that can be placed on a newborn infant's chest to sense its electrocardiogram and produce a sound and a light flash for each detected heart beat. Such a device can help to confirm that the infant is alive and that resuscitation should be attempted. It can also serve to confirm improvement in heart rate as the resuscitation proceeds. The proposed effort is directed at developing the device including electronics, sensing electrodes, and packaging and then to evaluate the device in clinical facilities domestically and in India. Further engineering improvements of the device will be made based upon these evaluations, and if successful the device could be used in a larger clinical study in the developing world to demonstrate its overall impact on reduction of worldwide infant mortality rates. An investigative team of a biomedical engineer, clinical physiologist in India, and neonatologist will ensure that the developed cardiac annunciator will be designed to meet clinical needs of the developing world as well as follow good engineering practices.