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Efficacy of a Low-cost Warming Mattress Celsi Warmer for the Management of Hypothermic Newborns at Muhimbili National Hospital, Dar es Salaam, Tanzania

Primary Purpose

Neonatal Hypothermia

Status
Recruiting
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Celsi Warmer Mattress
Sponsored by
William Marsh Rice University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Hypothermia

Eligibility Criteria

0 Days - 28 Days (Child)All SexesDoes not accept healthy volunteers

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 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 Kangaroo Mother Care (KMC) for reasons including, but not limited to: a.Mother/guardian unable or unavailable to provide KMC b.Under observation in 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, CPAP, oxygen therapy, IV fluids, management and monitoring of common newborn conditions such as hypoglycemia, and/or hyperbilirubinemia via LED phototherapy The study will not interfere with any other treatment being provided at the ward, and it will not delay the participant from transferring to KMC or being discharged Exclusion Criteria: Any neonate who: 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, 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 National HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypothermic Neonates (90)

Arm Description

Any neonate who 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 will be placed on the Celsi Warmer mattress

Outcomes

Primary Outcome Measures

Broad Objective
To evaluate the clinical efficacy and safety of the Celsi Warmer in rewarming hypothermic newborns by comparing the Celsi Warmer's accuracy in measuring neonatal temperature compared to the gold standard, axillary temperature readings.

Secondary Outcome Measures

Efficacy of the Device
To assess the performance of the Celsi Warmer in rewarming hypothermic newborns by measuring the incidence of attainment of normothermia (36.5-37.5°C)
Safety of Device
To measure the infant's rate of temperature (°C) increase through thermoregulatory intervention.
Safety of Device
To evaluate the local effect of the abdominal belt on newborn's skin by looking at any evidence of skin irritation
Safety of Device
To evaluate any incidence of hyperthermia (>37.5°C) during the thermoregulation intervention.
Safety of Device
To report any incidence of rebound hypothermia ( < 36.5°C) (post-intervention hypothermia) up to 72 hours from the initial encounter

Full Information

First Posted
April 3, 2023
Last Updated
May 31, 2023
Sponsor
William Marsh Rice University
Collaborators
Muhimbili University of Health and Allied Sciences, Ifakara Health Institute, Ministry of Health, Community Development, Gender, Elderly, and Children (MOHCDGEC)
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1. Study Identification

Unique Protocol Identification Number
NCT05876884
Brief Title
Efficacy of a Low-cost Warming Mattress Celsi Warmer for the Management of Hypothermic Newborns at Muhimbili National Hospital, Dar es Salaam, Tanzania
Official Title
Efficacy of a Low-cost Warming Mattress Celsi Warmer for the Management of Hypothermic Newborns at Muhimbili National Hospital, Dar es Salaam, Tanzania
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 20, 2024 (Anticipated)
Study Completion Date
August 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
William Marsh Rice University
Collaborators
Muhimbili University of Health and Allied Sciences, Ifakara Health Institute, Ministry of Health, Community Development, Gender, Elderly, and Children (MOHCDGEC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 comorbidity, and has been linked to a reduction in the effectiveness of treatment for other newborn conditions. Thermal care for hypothermic newborns is not widely available in low-resource settings due to cost, and lack of consumables and spare parts. In this study, the research team will evaluate the efficacy of a novel neonatal warming mattress intreating hypothermic newborns. The warming mattress, 'Celsi Warmer', has been developed by Rice360 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 to90eligible infants at Muhimbili National Hospital (MNH) at Upanga Neonatal Unit 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Hypothermia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypothermic Neonates (90)
Arm Type
Experimental
Arm Description
Any neonate who 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 will be placed on the Celsi Warmer mattress
Intervention Type
Device
Intervention Name(s)
Celsi Warmer Mattress
Intervention Description
The hypothermic neonate will be placed on the Celsi Warmer mattress and a temperature probe will be placed on the neonate to monitor the temperature of the neonate for up to 24 hours of intervention time
Primary Outcome Measure Information:
Title
Broad Objective
Description
To evaluate the clinical efficacy and safety of the Celsi Warmer in rewarming hypothermic newborns by comparing the Celsi Warmer's accuracy in measuring neonatal temperature compared to the gold standard, axillary temperature readings.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Efficacy of the Device
Description
To assess the performance of the Celsi Warmer in rewarming hypothermic newborns by measuring the incidence of attainment of normothermia (36.5-37.5°C)
Time Frame
1 year
Title
Safety of Device
Description
To measure the infant's rate of temperature (°C) increase through thermoregulatory intervention.
Time Frame
1 year
Title
Safety of Device
Description
To evaluate the local effect of the abdominal belt on newborn's skin by looking at any evidence of skin irritation
Time Frame
1 year
Title
Safety of Device
Description
To evaluate any incidence of hyperthermia (>37.5°C) during the thermoregulation intervention.
Time Frame
1 year
Title
Safety of Device
Description
To report any incidence of rebound hypothermia ( < 36.5°C) (post-intervention hypothermia) up to 72 hours from the initial encounter
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
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 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 Kangaroo Mother Care (KMC) for reasons including, but not limited to: a.Mother/guardian unable or unavailable to provide KMC b.Under observation in 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, CPAP, oxygen therapy, IV fluids, management and monitoring of common newborn conditions such as hypoglycemia, and/or hyperbilirubinemia via LED phototherapy The study will not interfere with any other treatment being provided at the ward, and it will not delay the participant from transferring to KMC or being discharged Exclusion Criteria: Any neonate who: 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, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Massey, MPH, BSN, RN
Phone
7133482923
Email
rebecca.elias@rice.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sonia Sosa Saenz, BME
Email
soniasosa@rice.edu
Facility Information:
Facility Name
Muhimbili National Hospital
City
Dar Es Salaam
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nahya Salim Masoud, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of a Low-cost Warming Mattress Celsi Warmer for the Management of Hypothermic Newborns at Muhimbili National Hospital, Dar es Salaam, Tanzania

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