Efficacy of Celsi Warmer for the Management of Hypothermic Newborns
Newborn Hypothermia
About this trial
This is an interventional treatment trial for Newborn Hypothermia
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Muhimbili University of Health and Allied Sciences (MUHAS)Recruiting
Arms of the Study
Arm 1
Experimental
Neonatal
A trained study nurse or clinician will transfer the enrolled participant to the study location and place the infant on the Celsi Warmer mattress. A trained study nurse or 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 A trained study nurse or clinician will wrap the baby according to the standard care at the hospital. Study personnel may observe the participant during the intervention period and annotate timestamped events that might affect temperature measurement and/or thermoregulation support intervention. Study personnel will perform routine abdominal skin assessments as often as every two hours and at least every 8 hours to observe for skin irritation or indentation. Thermoregulation support intervention will be provided as long as the infant continues to meet criteria for continued care at clinician's discretion.