Efficacy of a Low-cost Warming Mattress Celsi Warmer for the Management of Hypothermic Newborns at Muhimbili National Hospital, Dar es Salaam, Tanzania
Neonatal Hypothermia
About this trial
This is an interventional treatment trial for Neonatal Hypothermia
Eligibility Criteria
Inclusion Criteria: Any neonate who: 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 Kangaroo Mother Care (KMC) for reasons including, but not limited to: a.Mother/guardian unable or unavailable to provide KMC b.Under observation in NICU before transfer to KMC c.No space in KMC d.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 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: Requires mechanical ventilation Is deemed in need of intensive care by the hospital staff who is providing care,including but not limited to: a.neonates with severe anemia and/or any suspected hematological disorders, and/or b. Neonates with obvious congenital anomalies, and/or c.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
Sites / Locations
- Muhimbili National HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Hypothermic Neonates (90)
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