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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
A trained study clinician will attach the Celsi Warmer temperature sensor to the abdomen and secure it with the abdominal belt according to the device's instruction manual (such that the temperature sensor is positioned using a vertical line from the mid-clavicular line and just below the ribs). The time of sensor placement will be recorded.
University of Lagos, Lagos, Nigeria
Lagos, Nigeria
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 - Rate of Temperature Increase
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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