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

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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. PUBLIC HEALTH RELEVANCE: A low-cost device that can be placed on the chest of a newborn infant and indicate each heart beat by a sound and light flash is proposed. The device will be designed to be used by birth attendants in the developing world to indicate that nonresponsive newly born infants are indeed alive and to encourage resuscitation of these infants. Such a device could help to reduce infant mortality, 98% of which occurs in the developing world. Engineering development and clinical evaluation of the device will be done as a part of the proposed effort.