![]() Once Phase I is complete, Phase II will begin. Upon removal of the abdominal strap at the end of the study, the subject may be monitored for up to one hour in order to assess the effect of the abdominal strap on the skin of the subject. ![]() The research assistant may ask the nurse to remove and reapply the temperature monitor during this period. Temperature monitoring will continue for up to 3 days. The trained study nurse will attach the temperature probe from the commercial patient monitor as well as provide any other care needed.Ī research assistant will use a laptop to collect the electrical signals from both temperature monitors. They will also be able to answer any technical questions from the nurse. A trained research assistant from Rice University or from the Biomedical Engineering Department at Malawi Polytechnic will observe all procedures and will notify the nurse of any observed errors so they may be corrected. The second phase will test the effectiveness of the IncuBaby device using that temperature sensor to regulate the heat of the infant.ĭuring Phase I, the following steps will be taken:Ī trained study nurse will assess the subject for clinical complications before attaching the temperature monitoring device.Ī trained study nurse or clinician will attach the temperature monitoring device to the infant. ![]() The first phase will validate the use of the temperature sensor in infants by comparing it to a commercial temperature monitor. The temperature sensor that controls the heat of the incubator based on the infant's temperature has been previously evaluated in Rice IRB approved studies in Houston, TX with plans to evaluate at QECH. This is a two-phase, pilot prospective study to determine the effectiveness of a low-cost incubator in warming infants and regulating their temperatures. Condition or diseaseĭevice: Continuous temperature monitor Device: Neonatal Incubator Device: Patient monitor The proportion of time the device maintains the subject's temperature in a normal range will also be calculated. To determine the effectiveness of the IncuBaby device at warming infants, the temperatures of the infants will be compared before and after treatment for each subject. Care will continue at the clinician's discretion until the infant can be weaned from the incubator or until patients are withdrawn from the study and placed on the standard of care. During phase II of the study, infants in need of thermal care with an incubator will be treated with an IncuBaby device and their temperatures will be continuously monitored by both the temperature sensor of the IncuBaby device and a commercially available patient monitor. The accuracy of the IncuBaby temperature sensor will be determined by calculating the difference between the temperatures recorded by the temperature sensor and the commercial patient monitor at each point in time. During phase I of this study, the infants will be continuously monitored using the IncuBaby temperature sensor and a gold standard temperature monitor for up to 3 days. In this study, researchers intend to evaluate the efficacy of this incubator at QECH by comparing infants' temperatures before and after treatment, and calculating the proportion of time that the infants remain in a normothermic range after rewarming. This robust, low-cost device will allow for the individualized treatment of hypothermia with minimal intervention from the clinical staff. Why Should I Register and Submit Results?Ī team of researchers at Rice University and Queen Elizabeth Central Hospital (QECH) are working to develop a low-cost infant incubator called "IncuBaby" that consists of two components: a temperature sensor that can continuously monitor an infant's temperature, and a heated, enclosed area that can adjust internal temperature based on the feedback from the temperature sensor.
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