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| Name | Class |
|---|---|
| Muhimbili University of Health and Allied Sciences | OTHER |
| Ifakara Health Institute | OTHER |
| Ministry of Health, Community Development, Gender, Elderly, and Children (MOHCDGEC) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypothermic Neonates (90) | Experimental | Any neonate who been identified as in need of thermal care defined as having a moderate hypothermic temperature (32.0 - 36.0°C) as the last temperature recorded in hospital chart, or during recruitment procedures will be placed on the Celsi Warmer mattress |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celsi Warmer Mattress | Device | The hypothermic neonate will be placed on the Celsi Warmer mattress and a temperature probe will be placed on the neonate to monitor the temperature of the neonate for up to 24 hours of intervention time |
| Measure | Description | Time Frame |
|---|---|---|
| Broad Objective | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 year |
| Safety of Device |
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Inclusion Criteria:
Any neonate who:
The study will not interfere with any other treatment being provided at the ward, and it will not delay the participant from transferring to KMC or being discharged
Exclusion Criteria:
Any neonate who:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Massey, MPH, BSN, RN | Contact | 7133482923 | rebecca.elias@rice.edu | |
| Sonia Sosa Saenz, BME | Contact | soniasosa@rice.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muhimbili National Hospital | Recruiting | Dar es Salaam | Tanzania |
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To measure the infant's rate of temperature (°C) increase through thermoregulatory intervention.
| 1 year |
| Safety of Device | To evaluate the local effect of the abdominal belt on newborn's skin by looking at any evidence of skin irritation | 1 year |
| Safety of Device | To evaluate any incidence of hyperthermia (>37.5°C) during the thermoregulation intervention. | 1 year |
| Safety of Device | To report any incidence of rebound hypothermia ( < 36.5°C) (post-intervention hypothermia) up to 72 hours from the initial encounter | 1 year |