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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05876884
Study type Interventional
Source William Marsh Rice University
Contact Rebecca Massey, MPH, BSN, RN
Phone 7133482923
Email rebecca.elias@rice.edu
Status Recruiting
Phase N/A
Start date August 1, 2022
Completion date August 20, 2024

See also
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Recruiting NCT03965312 - Pilot Clinical Assessment of Low-cost Infant Incubator in Monitoring Temperature and Treating Hypothermia in Infants N/A
Completed NCT03316716 - Active Warming Versus Non Active Warming During Caesarean Section for Preventing Neonatal Hypothermia N/A
Not yet recruiting NCT04364204 - Hypothermia Prevention in Low Birthweight and Preterm Infants N/A
Recruiting NCT06003140 - Efficacy of Celsi Warmer for the Management of Hypothermic Newborns at the Lagos University Teaching Hospital in Lagos, Nigeria N/A