Newborn Hypothermia
Conditions
Brief summary
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.
Interventions
DEVICECelsi Warmer
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.
Sponsors
Muhimbili University of Health and Allied Sciences
William Marsh Rice University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Days to 28 Days
Healthy volunteers
No
Inclusion criteria
* Is currently being treated at study location * Is an inborn admission to the neonatal ward * Whose parents or guardians provided a written informed consent * Whose parents or guardians providing informed consent are 18 years old or older * Has a current weight of greater than or equal to 1.0 kg and less than or equal to 4.0kg * Has 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; and * Is unable to be enrolled in KMC for reasons including, but not limited to: 1. Mother/guardian unable or unavailable to provide KMC 2. Under observation in NICU before transfer to KMC 3. No space in KMC 4. Clinician's discretion * May be receiving other medical treatments, including but not limited to, CPAP, oxygen therapy, IV fluids, management and monitoring of common newborn conditions such as hypoglycemia, and/or hyperbilirubinemia via LED phototherapy
Exclusion criteria
* Requires mechanical ventilation * deemed in need of intensive care by the hospital staff who is providing care,including but not limited to: 1. Neonates with severe anemia and/or any suspected hematological disorders, and/or 2. Neonates with obvious congenital anomalies, and/or 3. neonates suspected with hypo/hyperthyroidism or any hormonal disorders * Has been diagnosed with birth asphyxia * Presents a condition that precludes the use of the temperature sensor and/or abdominal belt including but not limited to, gastroschisis, known umbilical cord infection, known skin infection * Whose clinician presents concerns about their participation * Is receiving treatment that participation in the study would interfere with, i.e.transferring to KMC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Broad Objective - Comparison to the Gold Standard of Rewarming Hypothermic Newborns | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of the Device | 1 year | 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) |
| Safety of the Device - Measure of Infant's Increase in Temperature | 1 year | To measure the infant's rate of temperature (°C) increase through thermoregulatory intervention. |
| Safety of the Device - Local Effect of the Abdominal Belt | 1 year | To evaluate the local effect of the abdominal belt on newborn's skin by looking at any evidence of skin irritation |
| Safety of the Device - Incidence of Hyperthermia | 1 year | To evaluate any incidence of hyperthermia (\>37.5°C) during the thermoregulation intervention. |
| Safety of the Device - Incidence of Rebound Hypothermia | 1 year | To report any incidence of rebound hypothermia ( \< 36.5°C) (post-intervention hypothermia) up to 72 hours from the initial encounter. |
Countries
Tanzania
Contacts
Primary ContactSonia Sosa Saenz, BME
Backup ContactNatalie Mitchell
Outcome results
None listed