Significant progress has been made in the science of electrocardiography since 1938. Heart rate and biophysical profiles are routinely derived from multi-lead electrocardiograms (ECGs) in animals and humans after birth. In contrast, only limited heart monitoring technologies exist for the fetus. Moreover, available technology fails to satisfy many existing needs in fetal ECG monitoring, both to support fundamental research on fetal development, and for clinical assessment of fetal health. This grant application proposes to reduce the technology gap that persists in fetal ECG monitoring in order to support advanced assessments of fetal health and development. The goal of this technology is to 1) monitor the fetal condition in an objective, quantitative, and non-invasive manner by enabling continuous and highly specific data collection during pre-natal development and the intra-partum period, 2) aid in the fetal and maternal treatment planning regimen potentially earlier than presently feasible, thus facilitating or indicating interventions which may reduce maternal and fetal morbidity and mortality, 3) maximize the health and well-being of the mother and fetus by reducing unnecessary or ineffective interventions (e. g., unnecessary C-sections) and the number of babies born with effects of such interventions, and 4) support fetal development research. Specific aims are directed to the refinement and validation of the technology for the purpose of prototyping a device that is fully automated, requires no user intervention, and produces a relevant quantitative output in real time. The specific aims of this Phase 1 effort include: 1) automating and optimizing the existing signal processing parameter controls by eliminating current requirement for certain operator decisions ("man-in-the-loop") during processing, and 2) designing a robust and clinically acceptable data collection interface to the patient by optimizing the data collection hardware configuration. This research will serve to further the experimental technology advanced in the existing research by providing the capability to collect transabdominal fetal ECG data without multiple, individually applied electrodes, making such monitoring valuable as a commercial application and more accessible to the research community. In addition, the proposed instrumentation will overcome existing limitations in accuracy resulting from data averaging to extract the maternal ECG. In this regard, the development of the new fetal heart rate technology not only has significant commercial potential, but offers the research community new tools to assess fetal health and fetal development.
Thesaurus Terms: biomedical equipment development, data collection, electrocardiography, embryo /fetus monitoring, heart function, patient monitoring device biomedical automation, computer assisted diagnosis clinical research
