View clinical trials related to Neonatal Hypothermia.
Filter by:The prevalence of hypothermia across low-resource settings is high, especially in countries with high neonatal mortality rates. If left untreated, hypothermia can additionally result in a significant comorbidity, and has been linked to a reduction in the effectiveness of treatment for other newborn conditions. Effective thermal care for hypothermic newborns is not widely available in low-resource settings due to cost of consumables and spare parts. In this study, the research team wish to evaluate the efficacy of a novel neonatal warming mattress in treating hypothermic newborns. Warming mattress, 'Celsi Warmer', has been developed by Rice 360 Institute for Global Health Technologies, in conjunction with African clinicians, to be a robust, low-cost, and easy-to-use warming mattress which can address the challenges of hypothermia. This is a single-arm, non-randomized, prospective intervention study. Up to 90 eligible infants at the neonatal wards of the Lagos University Teaching Hospital will be recruited to evaluate the efficacy of Celsi Warmer in rewarming hypothermic newborns. Infants temperature will be monitored during thermal intervention and the performance of the device will be evaluated. The temperatures of each infant will be compared before, during, and after the intervention.
The prevalence of hypothermia across low-resource settings is high, especially in countries with high neonatal mortality rates. If left untreated, hypothermia can additionally result in a significant comorbidity, and has been linked to a reduction in the effectiveness of treatment for other newborn conditions. Thermal care for hypothermic newborns is not widely available in low-resource settings due to cost, and lack of consumables and spare parts. In this study, the research team will evaluate the efficacy of a novel neonatal warming mattress intreating hypothermic newborns. The warming mattress, 'Celsi Warmer', has been developed by Rice360 Institute for Global Health Technologies, in conjunction with African clinicians, to be a robust, low-cost, and easy-to-use warming mattress which can address the challenges of hypothermia. This is a single-arm, non-randomized, prospective intervention study. Up to90eligible infants at Muhimbili National Hospital (MNH) at Upanga Neonatal Unit will be recruited to evaluate the efficacy of Celsi Warmer in rewarming hypothermic newborns. Infants temperature will be monitored during thermal intervention and the performance of the device will be evaluated. The temperatures of each infant will be compared before, during, and after the intervention.
Neonatal mortality remains unacceptably high. Globally, the majority of mothers now deliver in health facilities in low resource settings where quality of newborn care is poor. Health systems strengthening through digitial quality improvement systems, such as the Neotree, are a potential solution. The overarching aim of this study is to complete the co-development of NeoTree-gamma with key functionalities configured, operationalised, tested and ready for large scale roll out across low resource settings. Specific study objectives are as follows: 1. To further develop and test the NeoTree at tertiary facilities in Malawi and Zimbabwe 2. To investigate HCPs and parent/carer view of the NeoTree, including how acceptable and usable HCWs find the app, and potential barriers and enablers to implementing/using it in practice. 3. To collect outcome data for newborns from representative sites where NeoTree is not implemented. 4. To test the clinical validity of key NeoTree diagnostic algorithms, e.g. neonatal sepsis and hypoxic ischaemic encephalopathy (HIE) against gold standard or best available standard diagnoses. 5. To add dashboards and data linkage to the functionality of the NeoTree 6. To develop and test proof of concept for communicating daily electronic medical records (EMR) using NeoTree 7. To initiate a multi-country network of newborn health care workers, policy makers and academics. 8. To estimate cost of implementing NeoTree at all sites and potential costs at scale
Preterm infants are at risk of hypothermia following delivery and in the first few hours of life. Hypothermia in extremely low birth weight infants' is an independent risk factor for death. These infants' are at additional risk of hypothermia when they undergo procedures such as central catheter insertion following admission. The investigators think that in extremely preterm infants, placing a peripheral intravenous cannula on admission to the NICU, instead of umbilical catheters (UVC and/or UAC), will increase the proportion of infants with a rectal temperature in the normal range at 2 hours of life.
A 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. This robust, low-cost device will allow for the individualized treatment of hypothermia with minimal intervention from the clinical staff. 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. 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. 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 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. 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. 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. The proportion of time the device maintains the subject's temperature in a normal range will also be calculated.
A team of researchers at Rice University and Queen Elizabeth Central Hospital (QECH) are working to develop a low-cost temperature sensor that can continuously monitor an infant's temperature (NTM). This robust, low-cost device will allow for the individualized monitoring of each infant with alerts for hypo and hyperthermia. A reusable band placed around the infant's abdomen to hold the temperature sensor will eliminate disposable components. This study will assess the accuracy of this novel device against a gold standard (Philips Intellivue patient monitor) and up to two existing devices (Bempu and Thermospot).