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

描述（申请人提供）：全世界每年有370万新生儿死亡和260万死胎，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无反应的新生儿是活着的，可以复苏。这项计划的目标是开发和评估一种简单的仪器，称为心脏信号器，可以放置在新生儿的胸部来感知其心电图，并为每个检测到的心跳产生声音和闪光。这样的设备可以帮助确认婴儿是活着的，应该尝试复苏。随着复苏的进行，它还可以用于确认心率的改善。拟定的工作旨在开发包括电子器件、传感电极和包装在内的器械，然后在国内和印度的临床机构中对器械进行评价。将根据这些评价对该器械进行进一步的工程改进，如果成功，该器械可用于发展中国家的更大规模临床研究，以证明其对降低全球婴儿死亡率的总体影响。一个由印度的生物医学工程师、临床生理学家和心脏病学家组成的调查小组将确保所开发的心脏信号器的设计能够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.