Status:
RECRUITING
Efficacy of Celsi Warmer for the Management of Hypothermic Newborns at the Lagos University Teaching Hospital in Lagos, Nigeria
Lead Sponsor:
William Marsh Rice University
Collaborating Sponsors:
University of Lagos, Nigeria
Conditions:
Neonatal Hypothermia
Eligibility:
All Genders
1-28 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Any neonate who:
- Is currently being treated at study location,
- Is an inborn admission to the neonatal ward,
- Whose parents or guardians provided 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 4.0 kg,
- Has been identified as in need of thermal care defined as having a moderate to severe 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 the Neonatal Intensive Care Unit (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, Continuous Positive Airway Pressure (CPAP), oxygen therapy, intravenous (IV) fluids, management and monitoring of common newborn conditions such as hypoglycemia, and/or hyperbilirubinemia.
Exclusion
- 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, 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 (e.g. transferring to KMC).
Key Trial Info
Start Date :
August 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 21 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06003140
Start Date
August 15 2023
End Date
October 21 2024
Last Update
June 7 2024
Active Locations (1)
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1
University of Lagos, Lagos, Nigeria
Lagos, Nigeria