SBIR-STTR Award

Effective methods for measuring total energy expenditure in infants, including resting and sleeping metabolic rates, are lacking. Therefore, we developed a prototype device, the "Enhanced Metabolic Testing Activity Chamber; EMTAC," which was utilized to obtain measurements of total energy expenditure and physical activity in infants. This prototype includes sensors for respiratory gases, a system for measuring physical activity, a computer programmed to process the data and glove ports for parental contact. We have successfully determined total energy expenditure in 22 infants, revealing minor flaws in the design. For example, the method for parental interaction does not allow skin-to-skin contact with the infant. The system used for physical activity measurements requires that a balance be in the chamber with the infant. The analyzer system is unacceptably difficult to operate and requires a tedious calibration procedure. This project will achieve the following. 1. Develop a means for interaction with the infant that allows skin-to-skin contact. 2. Employ new technology to simplify the electronics. 3. Rewrite the EMTAC software to improve user interface. 4. Improve the methodology for physical activity measurements. 5. Conduct initial study with 21 infants to test overall operation of the EMTAC. PROPOSED COMMERCIAL APPLICATION: It is our intent to develop this metabolic instrument for use by nutritionists and other health care specialists to provide improved nutritional support for infants undergoing treatment for various metabolic disorders.

Backqround. We have developed a novel instrument for energy expenditure measurements in infants The data obtained with this equipment has contributed significantly to the knowledge of infant metabolism and nutrition and has led to four scientific publications in highly ranked peer-reviewed journals. Specific aims: Our major objective is to fabricate the EMTAC 3000i which will be a more portable and user friendly instrument This will allow bedside, as well as metabolic measurements in both in and out patient settings In this manner the EMTAC will be used beyond the laboratory where Phase I testing took place In Phase II of this proposal we have outlined the engineering advancements in order to accomplish the development of the new equipment Moreover, we have established a relationship with three centers of excellence who will lend their resources and expertise to enrich and cross-fertilize the EMTAC These centers include The Sansum Medical Research Institute, Santa Barbara, California, The Primate Behavior Laboratory of the State University of New York, Brooklyn, NY and The Fima Lifshitz Metabolic Unit at The Hospital Universitario Professor Edgar Santos, Salvador, Bahia, Brazil In each one of these centers, the feasibility of EMTAC will be tested in specific models of nutritional entities These include infants born to obese and/or diabetic parents and an experimental animal model of obesity in primates On the other side of the nutritional spectrum, infants with severe primary malnutrition will be studied in Brazil These studies will provide additional data for the understanding of the pathophysiology of each of these entities, thereby helping to improve the health of children world wide The work proposed will also prove that the EMTAC is suitable for use in distant laboratories under a variety of conditions and will set the stage for developing market areas for this instrument Finally, we have already begun the process of obtaining patent protection for the EMTAC Furthermore, we will seek approvals from both the Federal Drug Administration as well as Underwriters Laboratory during the period of this application This is further outlined in a detailed product development plan that is included with this application Summary: We have already proven that the EMTAC is a viable tool in regards to infant energy expenditure assessments Future testing as proposed in this application will provide important information in regards to the performance of EMTAC in different environments Finally, the new work in experimental animals will prove that EMTAC is a viable instrument for use in areas not explored previously.

Thesaurus Terms:
basal metabolism, bioenergetics, biomedical equipment development, body physical activity, infant human (0-1 year), patient monitoring device calorimetry, parent offspring interaction bioengineering /biomedical engineering, clinical research, human subject