Clinical trial NCT06000826: Efficacy of Celsi Warmer for the Management of Hypothermic Newborns
Official title: Efficacy of a Low-cost Warming Mattress Celsi Warmer for the Management of Hypothermic Newborns
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Newborn Hypothermia
Lead sponsor: William Marsh Rice University
Sponsor class: OTHER
Collaborators: name: Muhimbili University of Health and Allied Sciences
First posted: 2023-08-21
Enrollment: 90
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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, research participants will receive thermal care via the Celsi Warmer. Aside from thermal treatment, research participants will receive the standard of care from the neonatal unit, and will also be closely monitored by study personnel throughout the study. The results from this study will allow us to determine if the Celsi Warmer is an effective tool for warming and monitoring newborns in wards of low-resource hospitals. The research team hopes to demonstrate that the Celsi Warmer is effective for the appropriate treatment of newborn hypothermia in hospitals in low-resource settings.


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:

  1. Mother/guardian unable or unavailable to provide KMC
  2. Under observation in NICU before transfer to KMC
  3. No space in KMC
  4. 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:

  1. Neonates with severe anemia and/or any suspected hematological disorders, and/or
  2. Neonates with obvious congenital anomalies, and/or
  3. 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

Primary outcomes:
measure: Broad Objective - Comparison to the Gold Standard of Rewarming Hypothermic Newborns
timeFrame: 1 year
Secondary outcomes:
measure: Efficacy of the Device
timeFrame: 1 year
measure: Safety of the Device - Measure of Infant's Increase in Temperature
timeFrame: 1 year
measure: Safety of the Device - Local Effect of the Abdominal Belt
timeFrame: 1 year
measure: Safety of the Device - Incidence of Hyperthermia
timeFrame: 1 year
measure: Safety of the Device - Incidence of Rebound Hypothermia
timeFrame: 1 year
Other outcomes:
Locations:
city: Dar Es Salaam
country: Tanzania
facility: Muhimbili University of Health and Allied Sciences (MUHAS)
Study officials:
affiliation: William Marsh Rice University
name: Rebecca R Richards-Kortum, PhD
role: PRINCIPAL_INVESTIGATOR
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