Back to resultsTrial of a Non Electric Infant Warmer for Prevention and Treatment of Hypothermia in Rwanda
Primary Purpose
Hypothermia Neonatal
Status
Unknown status
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 not available for KMC, or KMC is not adequate (less than 0.5°C/hour rise in temperature):
Axillary temperature < 36.5 °C
a) If an electric warmer is available and the infant's temperature is < 35°C, then the infant will start by being warmed on the electric warmer until the infant's temperature reaches 36°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 the 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 KMC (medical instability) and electrical heating source available.
- Any infant with initial temperature < 35°C and electrical heating source available.
- Infants requiring phototherapy.
- Infants with significant skin condition.
Stop Criteria:
If an electric heating source is available, the infant will be taken off of the study and warmed with an appropriate source of electric heat if the infant:
If an electric heating source is available, the infant will be taken off of the study and warmed with an appropriate source of electric heat if the infant:
i. Has temp < 36 °C while receiving maximum non-electric heat exposure and temperature decreases on any measurement ii. Has temp < 36 °C while receiving maximum non-electric heat exposure and temperature does not begin to rise within 30 minutes iii.Has temp < 36 °C while receiving maximum non-electric heat exposure and not heating at a rate of > ½ °C per hour until temperature >36.5°C iv.Has a temperature that falls below 36°C despite maximum non-electric heat exposure
Definition of maximum non-electric heat exposure:
- IW, KMC, hat; if KMC available
- IW, blanket, hat; if KMC not available
- Blanket, hat; while seeking caregiver for KMC and/or preparing IW if KMC and IW not available
- Has temperature > 37.5 °C
- 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 phase change temperature as assessed by noting that the material begins to harden and turn white and is no longer warm in area under where baby is lying.
Sites / Locations
- Dr Evrard Nahimana
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Non-Electric Infant Warmer
Control
Arm Description
In line with current recommended practice, the mother will be encouraged to provide KMC whenever possible. For hypothermic infants, if the temperature is not rising by ½°C per hour with KMC alone, the Infant Warmer will be offered as an addition. In these cases, the heat will be provided by placing the Infant Warmer over the infant's back while the mother provides KMC. If the mother is not available for KMC at any time, the infant will be warmed exclusively with the Infant Warmer by being placed directly on the warmer as it lies flat. Use of hat and socks will be encouraged by additional clothes will only be added in addition to the warmer per caregiver request, as it reduces heat transfer.
Data such as infant temperature, date of birth, etc. will be collected from those who enroll in the control group. No experimental intervention will be administered.
Outcomes
Primary Outcome Measures
Ability to regulate infant body temperature
The infant warmer will be evaluated on its ability to 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. Infants temperature will be measured, using a thermometer to ensure the body temperature will increase but not exceed 37.5°C.
Incidence of adverse events as assessed by staff observation
The investigators will assess the safety of the infant warmer by observing any adverse reactions such as skin irritations or higher than usual patient temperature (>37.5°C). The safety of the warmer will be measured by study staff observation, measuring the temperature of the warmer with a thermistor instrument, measuring the infant's temperature with a thermometer, as well an investigator-developed Observer Audit Form. The Observer Audit Form is a battery of nine questions which includes eight yes/no questions and one free response. The questions evaluate such topics as whether the warmer was cleaned, the infant was positioned correctly, if adverse events were present, etc.
Secondary Outcome Measures
Studying the practicality of applying the device in a clinical setting
The investigators will use observation to evaluate the usability of the warmer by assessing the way that the infant is placed on the warmer and any adverse effects of infant warmer use. This will be measured by study staff observation as well an investigator-developed Observer Audit Form. The Observer Audit Form is a battery of nine questions which includes eight yes/no questions and one free response. The questions evaluate such topics as whether the warmer was cleaned, the infant was positioned correctly, if adverse events were present, etc.
Functionality
The functionality will be assessed by the way that the warmer is prepared and cleaned, as well as any wear and tear on the warmer based on repeated use. Functionality will be measured by study staff observation as well an investigator-developed Observer Audit Form. The Observer Audit Form is a battery of eight questions which includes seven yes/no questions and one free response. The questions evaluate such topics as whether the warmer was cleaned, the infant was positioned correctly, if adverse events were present, etc.
Full Information
NCT ID
NCT03890211
First Posted
March 21, 2019
Last Updated
February 10, 2021
Sponsor
Boston Children's Hospital
Collaborators
Ministry of Health, Rwanda, Rwandan Biomedical Counsel (RBC), Harvard Medical School (HMS and HSDM), Partners in Health, Rwanda National Ethics Committee (RNEC), Lawrence Berkeley National Laboratory
1. Study Identification
Unique Protocol Identification Number
NCT03890211
Brief Title
Trial of a Non Electric Infant Warmer for Prevention and Treatment of Hypothermia in Rwanda
Official Title
Stepped Wedge Randomized Control Trial of a Non Electric Infant Warmer for Prevention and Treatment of Hypothermia in Rwanda
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 11, 2019 (Actual)
Primary Completion Date
July 19, 2020 (Actual)
Study Completion Date
January 1, 2022 (Anticipated)
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), Partners in Health, Rwanda National Ethics Committee (RNEC), Lawrence Berkeley National Laboratory
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
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, for example 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 reliable in settings without stable electricity. After two encouraging pilot studies totaling 204 uses in 2 district hospitals and 4 health centers in rural Rwanda, the investigators aim to further study the warmer in a stepped wedge prospective controlled trial in hospital setting to assess safety and efficacy of the Infant Warmer based on clinical observation and feasibility based on observer audits.
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, for example 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 reliable in settings without stable electricity. The Infant Warmer the investigators propose to study has previously been tested in 2 pilot studies totaling 204 uses, occurring in 2 district hospitals and 4 health centers in rural Rwanda.
The combined results of these pilot studies were extremely encouraging. This study will be a stepped wedge prospective controlled trial in hospital setting to assess safety and efficacy of the Infant Warmer based on clinical observation, and feasibility based on observer audits. A total of 10 district hospitals will participate in the study. All 10 hospitals will start with a 2 week period of observation in which "pre" data will be collected. Hospitals will then receive the warmer and be transitioned to the "post" period at a rate of one every two weeks. The primary study aim is to assess the safety, efficacy and feasibility of the Infant Warmer as an addition to KMC, and to achieve and maintain euthermia when KMC is inadequate or unavailable. The study will be conducted across a wide range of district hospitals with control data coming from pre-intervention period and treatment data coming from post intervention period, with the intervention being the introduction of the Infant Warmer.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3179 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-Electric Infant Warmer
Arm Type
Experimental
Arm Description
In line with current recommended practice, the mother will be encouraged to provide KMC whenever possible. For hypothermic infants, if the temperature is not rising by ½°C per hour with KMC alone, the Infant Warmer will be offered as an addition. In these cases, the heat will be provided by placing the Infant Warmer over the infant's back while the mother provides KMC. If the mother is not available for KMC at any time, the infant will be warmed exclusively with the Infant Warmer by being placed directly on the warmer as it lies flat. Use of hat and socks will be encouraged by additional clothes will only be added in addition to the warmer per caregiver request, as it reduces heat transfer.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Data such as infant temperature, date of birth, etc. will be collected from those who enroll in the control group. No experimental intervention will be administered.
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
Ability to regulate infant body temperature
Description
The infant warmer will be evaluated on its ability to 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. Infants temperature will be measured, using a thermometer to ensure the body temperature will increase but not exceed 37.5°C.
Time Frame
up to 6 months
Title
Incidence of adverse events as assessed by staff observation
Description
The investigators will assess the safety of the infant warmer by observing any adverse reactions such as skin irritations or higher than usual patient temperature (>37.5°C). The safety of the warmer will be measured by study staff observation, measuring the temperature of the warmer with a thermistor instrument, measuring the infant's temperature with a thermometer, as well an investigator-developed Observer Audit Form. The Observer Audit Form is a battery of nine questions which includes eight yes/no questions and one free response. The questions evaluate such topics as whether the warmer was cleaned, the infant was positioned correctly, if adverse events were present, etc.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Studying the practicality of applying the device in a clinical setting
Description
The investigators will use observation to evaluate the usability of the warmer by assessing the way that the infant is placed on the warmer and any adverse effects of infant warmer use. This will be measured by study staff observation as well an investigator-developed Observer Audit Form. The Observer Audit Form is a battery of nine questions which includes eight yes/no questions and one free response. The questions evaluate such topics as whether the warmer was cleaned, the infant was positioned correctly, if adverse events were present, etc.
Time Frame
up to 6 months
Title
Functionality
Description
The functionality will be assessed by the way that the warmer is prepared and cleaned, as well as any wear and tear on the warmer based on repeated use. Functionality will be measured by study staff observation as well an investigator-developed Observer Audit Form. The Observer Audit Form is a battery of eight questions which includes seven yes/no questions and one free response. The questions evaluate such topics as whether the warmer was cleaned, the infant was positioned correctly, if adverse events were present, etc.
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any infant with the following criteria for whom caregiver not available for KMC, or KMC is not adequate (less than 0.5°C/hour rise in temperature):
Axillary temperature < 36.5 °C
a) If an electric warmer is available and the infant's temperature is < 35°C, then the infant will start by being warmed on the electric warmer until the infant's temperature reaches 36°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 the 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 KMC (medical instability) and electrical heating source available.
Any infant with initial temperature < 35°C and electrical heating source available.
Infants requiring phototherapy.
Infants with significant skin condition.
Stop Criteria:
If an electric heating source is available, the infant will be taken off of the study and warmed with an appropriate source of electric heat if the infant:
If an electric heating source is available, the infant will be taken off of the study and warmed with an appropriate source of electric heat if the infant:
i. Has temp < 36 °C while receiving maximum non-electric heat exposure and temperature decreases on any measurement ii. Has temp < 36 °C while receiving maximum non-electric heat exposure and temperature does not begin to rise within 30 minutes iii.Has temp < 36 °C while receiving maximum non-electric heat exposure and not heating at a rate of > ½ °C per hour until temperature >36.5°C iv.Has a temperature that falls below 36°C despite maximum non-electric heat exposure
Definition of maximum non-electric heat exposure:
IW, KMC, hat; if KMC available
IW, blanket, hat; if KMC not available
Blanket, hat; while seeking caregiver for KMC and/or preparing IW if KMC and IW not available
Has temperature > 37.5 °C
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 phase change temperature as assessed by noting that the material begins to harden and turn white and is no longer warm in area under where baby is lying.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Hansen, MD, MPH
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
Citations:
PubMed Identifier
33997734
Citation
Uwamariya J, Mazimpaka C, May L, Nshimyiryo A, Feldman HA, Sayinzoga F, Umutesi S, Gadgil A, Rapp VH, Nahimana E, Hansen A. Safety and effectiveness of a non-electric infant warmer for hypothermia in Rwanda: A cluster-randomized stepped-wedge trial. EClinicalMedicine. 2021 Apr 16;34:100842. doi: 10.1016/j.eclinm.2021.100842. eCollection 2021 Apr.
Results Reference
derived
Learn more about this trial
Trial of a Non Electric Infant Warmer for Prevention and Treatment of Hypothermia in Rwanda
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