Efficacy of Celsi Warmer for the Management of Hypothermic Newborns at the Lagos University Teaching Hospital in Lagos, Nigeria
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 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 Criteria: 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).
Sites / Locations
- University of Lagos, Lagos, NigeriaRecruiting
Arms of the Study
Arm 1
Experimental
Hypothermic Neonates (90)
A trained study clinician will attach the Celsi Warmer temperature sensor to the abdomen and secure it with the abdominal belt according to the device's instruction manual (such that the temperature sensor is positioned using a vertical line from the mid-clavicular line and just below the ribs). The time of sensor placement will be recorded.