Back to resultsElectricity-free Infant Warmer for Newborn Thermoregulation in Rwanda
Primary Purpose
Hypothermia Neonatal
Status
Completed
Phase
Not Applicable
Locations
Rwanda
Study Type
Interventional
Intervention
Non-Electric Infant Warmer
Sponsored by
About this trial
This is an interventional supportive care trial for Hypothermia Neonatal focused on measuring Hypothermia, Infant Warmer
Eligibility Criteria
Inclusion Criteria:
Any infant with the following criteria for whom caregiver is not available for Kangaroo Mother Care, or Kangaroo Mother Care is not adequate (less than ½ degree Celsius per hour rise in temperature).
- axillary temperature < 36 degrees C and ≥35 degrees C 1a) If an electric warmer is available and the infant's temperature is < 35 degrees C, then the infant would start by being warmed on the electric warmer until the infant's temperature reaches 36 degrees C, then can start non-electric infant warmer use
- Infants at-risk for hypothermia (criteria: estimated post-menstrual age of < 35 weeks or current body weight of < 2.5 kg)
Exclusion Criteria:
- Any infant whose family is unwilling to consent to study.
- Mothers who are critically ill at the time of infant eligibility or deemed not medically stable by nursing staff to be approached for consent.
- Any infant with a contraindication to Kangaroo Mother Care (medical instability) and electrical heating source available.
- Any infant with initial temperature < 35 degrees C and electrical heating source available.
- Infants within the first hour of admission to neonatal unit or first hour of life in maternity.
- Infants requiring phototherapy
- Infants with significant skin condition
- Infants with Hypoxic Ischemic Encephalopathy (HIE)
Stopping Criteria:
If an electric heating source is available, the infant will be taken off the study and warmed with an appropriate source of electric heat if the infant:
- Is hypothermic and temperature decreases on any measurement
- Is hypothermic and temperature does not begin to rise within 30 minutes
- Is hypothermic and not heating at a rate of > ½ degree C per hour until temperature is >36.5 degrees C
- Has a temperature that falls below 36 degrees C despite maximum exposure to the heat source
- Is ever considered to be too severely ill by the medical team to be safely cared for in the non-electric infant warmer.
- The warmer will be removed once its temperature drops below 36 degrees, and/or the phase change material begins to harden.
Sites / Locations
- Dr Evrard Nahimana
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Non-Electric Infant Warmer
Arm Description
In line with current recommended practice, mothers will be encouraged to provide Kangaroo Mother Care (KMC) whenever possible. If an infant's temp is not rising by ½ degree C per hour with KMC alone, the infant warmer will be offered as an addition by the study team. If the mother is not available for KMC at any time, the infant will be warmed exclusively with the warmer. Bundling in clothes will only be used in addition to the warmer per carer preference. Temp measurement of the infant, warmer, and ambient air will be measured every 15 mins for the first hr, then hrly and as needed for the remainder of use or until warmer endpoint is reached (warmer temp below 36 degrees or phase-change material hardens [soft, semisoft, or hardened]).
Outcomes
Primary Outcome Measures
Temperature/Effectiveness
The infant warmer will be evaluated on the number of time is able to successfully achieve and maintain a normal body temperature for patients who are hypothermic and those patients at risk of hypothermia because of a < 2.5 kg birth weight or < 35 week gestational age.
Secondary Outcome Measures
Usability
The investigators will use observation to evaluate the usability of the warmer by assessing whether or not the infant warmer was used in a way that deviated from its recommended use.
Functionality
The functionality will be assessed by whether or not there appeared to be wear and tear on the infant warmer based on repeated use.
Qualitative Survey
The same as primary outcome and secondary outcome as described above with the setting being clinic and transport based rather than in a hospital, and with the addition of qualitative questions for mother and nurse regarding infant warmer use.
Full Information
NCT ID
NCT03031431
First Posted
December 13, 2016
Last Updated
January 9, 2020
Sponsor
Boston Children's Hospital
Collaborators
Ministry of Health, Rwanda, Rwandan Biomedical Counsel (RBC), Harvard Medical School (HMS and HSDM), Institute for Transformative Technologies (ITT), Brigham and Women's Hospital, Partners in Health
1. Study Identification
Unique Protocol Identification Number
NCT03031431
Brief Title
Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda
Official Title
Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
July 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
Ministry of Health, Rwanda, Rwandan Biomedical Counsel (RBC), Harvard Medical School (HMS and HSDM), Institute for Transformative Technologies (ITT), Brigham and Women's Hospital, Partners in Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hypothermia contributes to a significant portion of neonatal deaths. Kangaroo mother care (KMC) is a safe and effective method of warming; however, it is not always feasible, and not possible in settings such as resuscitation or clinical instability. Electric warmers are the standard of care in developed countries, but are extremely costly, complicated with risk of causing both hypo and hyperthermia with misuse, and often not feasible in settings without stable electricity. Through a multi-institutional collaboration, the investigators have developed an electricity-free infant warmer. After laboratory based prototype testing for safety and efficacy, the investigators aim to study the supervised use of the warmer under routine implementation conditions in a resource-limited setting.
Detailed Description
Hypothermia contributes to a significant portion of neonatal deaths. Kangaroo mother care (KMC) is a safe and effective method of warming; however, it is not always feasible, and not possible in settings such as resuscitation or clinical instability. Electric warmers are the standard of care in developed countries, but are extremely costly, complicated with risk of causing both hypo and hyperthermia with misuse, and often not feasible in settings without stable electricity. Through a multi-institutional collaboration, the investigators have developed an electricity-free infant warmer. After laboratory based prototype testing for safety and efficacy, the investigators aim to study the supervised use of the warmer under routine implementation conditions in a resource-limited setting. The primary aim of Phase 1 is to determine if the infant warmer is a safe, effective, usable and functional addition to KMC. This is planned in a convenience sample of patients in two district hospitals, one in a relatively warm environment, and one in a colder setting using quantitative methods and observer audits of usability and functionality. After determination of safety and effectiveness and making any necessary modifications to the warmer, Phase 2 aims to study the warmer in rural health centers and transport, as this is where we ultimately aim to use the electricity free devices due to the limited access to functioning and stable electricity in these settings. The overall goal of the project is dissemination of the study results, and ultimately the infant warmer to the district and national level for key policy makers and stakeholders, as well as globally via publication.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia Neonatal
Keywords
Hypothermia, Infant Warmer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-Electric Infant Warmer
Arm Type
Experimental
Arm Description
In line with current recommended practice, mothers will be encouraged to provide Kangaroo Mother Care (KMC) whenever possible. If an infant's temp is not rising by ½ degree C per hour with KMC alone, the infant warmer will be offered as an addition by the study team. If the mother is not available for KMC at any time, the infant will be warmed exclusively with the warmer. Bundling in clothes will only be used in addition to the warmer per carer preference. Temp measurement of the infant, warmer, and ambient air will be measured every 15 mins for the first hr, then hrly and as needed for the remainder of use or until warmer endpoint is reached (warmer temp below 36 degrees or phase-change material hardens [soft, semisoft, or hardened]).
Intervention Type
Device
Intervention Name(s)
Non-Electric Infant Warmer
Intervention Description
Electric warmers are the standard of care in developed countries, but are extremely costly, complicated with risk of causing both hypo and hyperthermia with misuse, and often not feasible in settings without stable electricity. Through a multi-institutional collaboration, the investigators have developed an electricity-free infant warmer.
Primary Outcome Measure Information:
Title
Temperature/Effectiveness
Description
The infant warmer will be evaluated on the number of time is able to successfully achieve and maintain a normal body temperature for patients who are hypothermic and those patients at risk of hypothermia because of a < 2.5 kg birth weight or < 35 week gestational age.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Usability
Description
The investigators will use observation to evaluate the usability of the warmer by assessing whether or not the infant warmer was used in a way that deviated from its recommended use.
Time Frame
Up to 6 months
Title
Functionality
Description
The functionality will be assessed by whether or not there appeared to be wear and tear on the infant warmer based on repeated use.
Time Frame
Up to 6 months
Title
Qualitative Survey
Description
The same as primary outcome and secondary outcome as described above with the setting being clinic and transport based rather than in a hospital, and with the addition of qualitative questions for mother and nurse regarding infant warmer use.
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any infant with the following criteria for whom caregiver is not available for Kangaroo Mother Care, or Kangaroo Mother Care is not adequate (less than ½ degree Celsius per hour rise in temperature).
axillary temperature < 36 degrees C and ≥35 degrees C 1a) If an electric warmer is available and the infant's temperature is < 35 degrees C, then the infant would start by being warmed on the electric warmer until the infant's temperature reaches 36 degrees C, then can start non-electric infant warmer use
Infants at-risk for hypothermia (criteria: estimated post-menstrual age of < 35 weeks or current body weight of < 2.5 kg)
Exclusion Criteria:
Any infant whose family is unwilling to consent to study.
Mothers who are critically ill at the time of infant eligibility or deemed not medically stable by nursing staff to be approached for consent.
Any infant with a contraindication to Kangaroo Mother Care (medical instability) and electrical heating source available.
Any infant with initial temperature < 35 degrees C and electrical heating source available.
Infants within the first hour of admission to neonatal unit or first hour of life in maternity.
Infants requiring phototherapy
Infants with significant skin condition
Infants with Hypoxic Ischemic Encephalopathy (HIE)
Stopping Criteria:
If an electric heating source is available, the infant will be taken off the study and warmed with an appropriate source of electric heat if the infant:
Is hypothermic and temperature decreases on any measurement
Is hypothermic and temperature does not begin to rise within 30 minutes
Is hypothermic and not heating at a rate of > ½ degree C per hour until temperature is >36.5 degrees C
Has a temperature that falls below 36 degrees C despite maximum exposure to the heat source
Is ever considered to be too severely ill by the medical team to be safely cared for in the non-electric infant warmer.
The warmer will be removed once its temperature drops below 36 degrees, and/or the phase change material begins to harden.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Hansen, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Evrard Nahimana
City
Rwinkwavu
Country
Rwanda
12. IPD Sharing Statement
Plan to Share IPD
No
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Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda
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