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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. 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06003140
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 15, 2023
Completion date October 21, 2024

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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 NCT05876884 - Efficacy of a Low-cost Warming Mattress Celsi Warmer for the Management of Hypothermic Newborns at Muhimbili National Hospital, Dar es Salaam, Tanzania N/A