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Efficacy of Celsi Warmer for the Management of Hypothermic Newborns

Primary Purpose

Newborn Hypothermia

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

About this trial

This is an interventional treatment trial for Newborn Hypothermia

Eligibility Criteria

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

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

Arm Type

Experimental

Arm Label

Neonatal

Arm Description

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.

Outcomes

Primary Outcome Measures

Broad Objective - Comparison to the Gold Standard of Rewarming Hypothermic Newborns
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 the Device - Measure of Infant's Increase in Temperature
To measure the infant's rate of temperature (°C) increase through thermoregulatory intervention.
Safety of the Device - Local Effect of the Abdominal Belt
To evaluate the local effect of the abdominal belt on newborn's skin by looking at any evidence of skin irritation
Safety of the Device - Incidence of Hyperthermia
To evaluate any incidence of hyperthermia (>37.5°C) during the thermoregulation intervention.
Safety of the Device - Incidence of Rebound Hypothermia
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
May 31, 2023
Last Updated
August 18, 2023
Sponsor
William Marsh Rice University
Collaborators
Muhimbili University of Health and Allied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT06000826
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 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

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newborn 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
Neonatal
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Celsi Warmer
Intervention Description
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 the research team 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.
Primary Outcome Measure Information:
Title
Broad Objective - Comparison to the Gold Standard of Rewarming Hypothermic Newborns
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 the Device - Measure of Infant's Increase in Temperature
Description
To measure the infant's rate of temperature (°C) increase through thermoregulatory intervention.
Time Frame
1 year
Title
Safety of the Device - Local Effect of the Abdominal Belt
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 the Device - Incidence of Hyperthermia
Description
To evaluate any incidence of hyperthermia (>37.5°C) during the thermoregulation intervention.
Time Frame
1 year
Title
Safety of the Device - Incidence of Rebound Hypothermia
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sonia Sosa Saenz, BME
Phone
713-348-4963
Email
ss171@rice.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Natalie Mitchell
Email
natalie.d.mitchell@rice.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca R Richards-Kortum, PhD
Organizational Affiliation
William Marsh Rice University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muhimbili University of Health and Allied Sciences (MUHAS)
City
Dar Es Salaam
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nahya Salim, MMED
Phone
+255 713 250074
Email
nsalim@ihi.or.tz
First Name & Middle Initial & Last Name & Degree
Robert Moshiro, MMED
Phone
+255 713 35
Email
moshiror@gmail.com
First Name & Middle Initial & Last Name & Degree
Rebecca R Richards-Kortum, PhD
First Name & Middle Initial & Last Name & Degree
Maria Oden, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
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Efficacy of Celsi Warmer for the Management of Hypothermic Newborns

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