Status:
UNKNOWN
Efficacy of Celsi Warmer for the Management of Hypothermic Newborns
Lead Sponsor:
William Marsh Rice University
Collaborating Sponsors:
Muhimbili University of Health and Allied Sciences
Conditions:
Newborn Hypothermia
Eligibility:
All Genders
Up to 28 years
Phase:
NA
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, researc...
Eligibility Criteria
Inclusion
- 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:
- Mother/guardian unable or unavailable to provide KMC
- Under observation in NICU before transfer to KMC
- No space in KMC
- 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
- Requires mechanical ventilation
- deemed in need of intensive care by the hospital staff who is providing care,including but not limited to:
- Neonates with severe anemia and/or any suspected hematological disorders, and/or
- Neonates with obvious congenital anomalies, and/or
- 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
Key Trial Info
Start Date :
September 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 20 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06000826
Start Date
September 27 2022
End Date
August 20 2024
Last Update
August 22 2023
Active Locations (1)
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1
Muhimbili University of Health and Allied Sciences (MUHAS)
Dar es Salaam, Tanzania