Actively Recruiting
Efficacy of Celsi Warmer for the Management of Hypothermic Newborns at the Lagos University Teaching Hospital in Lagos, Nigeria
Led by William Marsh Rice University · Updated on 2024-06-07
90
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
Sponsors
W
William Marsh Rice University
Lead Sponsor
U
University of Lagos, Nigeria
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Celsi Warmer for the Management of Hypothermic Newborns at the Lagos University Teaching Hospital in Lagos, Nigeria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonates currently treated at the study location
- Inborn admission to the neonatal ward
- Parents or guardians are 18 years or older and have provided informed consent
- Baby weighs between 1.0 kg and 4.0 kg
- Baby has moderate to severe hypothermia (32.0-36.0 6C) as last recorded temperature
- Baby is unable to receive Kangaroo Mother Care due to various reasons such as mother unavailable, NICU observation, no space in KMC, or clinician's decision
- Baby may be receiving other medical treatments like CPAP, oxygen, IV fluids, or treatment for conditions like hypoglycemia or hyperbilirubinemia
You will not qualify if you...
- Baby requires mechanical ventilation
- Baby needs intensive care due to severe anemia, hematological disorders, congenital anomalies, or hormonal disorders
- Baby has been diagnosed with birth asphyxia
- Baby has conditions preventing use of temperature sensor or abdominal belt, like umbilical cord or skin infections
- Clinician has concerns about baby's participation
- Baby is receiving treatment that conflicts with study participation, such as transfer to Kangaroo Mother Care
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Lagos, Lagos, Nigeria
Lagos, Nigeria
Actively Recruiting
Research Team
R
Rebecca Massey, MPH, BSN, RN
CONTACT
S
Sonia Sosa Saenz, BME
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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