The purpose of the study is to evaluate the efficacy of a novel low-cost warming device to provide thermal care for newborn babies with hypothermia in low-resource hospitals. During the study, research participants will receive thermal care via the Celsi Warmer. Aside from thermal treatment, research participants will receive the standard of care from the neonatal unit, and will also be closely monitored by study personnel throughout the study. The results from this study will allow us to determine if the Celsi Warmer is an effective tool for warming and monitoring newborns in wards of low-resource hospitals. The research team hopes to demonstrate that the Celsi Warmer is effective for the appropriate treatment of newborn hypothermia in hospitals in low-resource settings.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
During the study, research participants will receive thermal care via the Celsi Warmer. Aside from thermal treatment, research participants will receive the standard of care from the neonatal unit, and will also be closely monitored by study personnel throughout the study. The results from this study will allow the research team to determine if the Celsi Warmer is an effective tool for warming and monitoring newborns in wards of low-resource hospitals. The research team hopes to demonstrate that the Celsi Warmer is effective for the appropriate treatment of newborn hypothermia in hospitals in low-resource settings.
Muhimbili University of Health and Allied Sciences (MUHAS)
Dar es Salaam, Tanzania
RECRUITINGBroad Objective - Comparison to the Gold Standard of Rewarming Hypothermic Newborns
To evaluate the clinical efficacy and safety of the Celsi Warmer in rewarming hypothermic newborns by comparing the Celsi Warmer's accuracy in measuring neonatal temperature compared to the gold standard, axillary temperature readings.
Time frame: 1 year
Efficacy of the Device
To assess the performance of the Celsi Warmer in rewarming hypothermic newborns by measuring the incidence of attainment of normothermia (36.5-37.5°C)
Time frame: 1 year
Safety of the Device - Measure of Infant's Increase in Temperature
To measure the infant's rate of temperature (°C) increase through thermoregulatory intervention.
Time frame: 1 year
Safety of the Device - Local Effect of the Abdominal Belt
To evaluate the local effect of the abdominal belt on newborn's skin by looking at any evidence of skin irritation
Time frame: 1 year
Safety of the Device - Incidence of Hyperthermia
To evaluate any incidence of hyperthermia (\>37.5°C) during the thermoregulation intervention.
Time frame: 1 year
Safety of the Device - Incidence of Rebound Hypothermia
To report any incidence of rebound hypothermia ( \< 36.5°C) (post-intervention hypothermia) up to 72 hours from the initial encounter.
Time frame: 1 year
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