Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda

• Sponsor: Boston Children's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03031431
• Collaborator: Ministry of Health, Rwanda (Other), Rwandan Biomedical Counsel (RBC) (Other), Harvard Medical School (HMS and HSDM) (Other), Institute for Transformative Technologies (ITT) (Other), Brigham and Women's Hospital (Other), Partners in Health (Other)
• Enrollment: 130
• Location: 1
• Arm: 1
• Duration (Months): 36
• Patients Per Site Per Month: 3.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypothermia Neonatal	Device: Non-Electric Infant Warmer	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda
• Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Jul 1, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Non-Electric Infant Warmer 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]).

Device: Non-Electric Infant Warmer; 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.

Outcome Measures

Primary Outcome Measures

1. Temperature/Effectiveness [Up to 6 months]

   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

1. Usability [Up to 6 months]

   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.

2. Functionality [Up to 6 months]

   The functionality will be assessed by whether or not there appeared to be wear and tear on the infant warmer based on repeated use.

3. Qualitative Survey [Up to 1 year]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 3 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

1. 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

2. Infants at-risk for hypothermia (criteria: estimated post-menstrual age of < 35 weeks or current body weight of < 2.5 kg)

Exclusion Criteria:

1. Any infant whose family is unwilling to consent to study.

2. Mothers who are critically ill at the time of infant eligibility or deemed not medically stable by nursing staff to be approached for consent.

3. Any infant with a contraindication to Kangaroo Mother Care (medical instability) and electrical heating source available.

4. Any infant with initial temperature < 35 degrees C and electrical heating source available.

5. Infants within the first hour of admission to neonatal unit or first hour of life in maternity.

6. Infants requiring phototherapy

7. Infants with significant skin condition

8. 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:

1. Is hypothermic and temperature decreases on any measurement

2. Is hypothermic and temperature does not begin to rise within 30 minutes

3. Is hypothermic and not heating at a rate of > ½ degree C per hour until temperature is

36.5 degrees C

1. Has a temperature that falls below 36 degrees C despite maximum exposure to the heat source

2. Is ever considered to be too severely ill by the medical team to be safely cared for in the non-electric infant warmer.

3. The warmer will be removed once its temperature drops below 36 degrees, and/or the phase change material begins to harden.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr Evrard Nahimana	Rwinkwavu		Rwanda

Sponsors and Collaborators

• Boston Children's Hospital
• 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

Investigators

• Principal Investigator: Anne Hansen, MD, Boston Children's Hospital

Study Documents (Full-Text)

• Study Protocol and Informed Consent Form - Feb 14, 2015

More Information

Publications

None provided.

• Responsible Party: Anne Hansen, MD, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT03031431
• Other Study ID Numbers: IRB-P00016205
• First Posted: Jan 25, 2017
• Last Update Posted: Jan 13, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Anne Hansen, MD, Boston Children's Hospital: Hypothermia; Infant Warmer
• Additional relevant MeSH terms: Hypothermia

Study Results

Participant Flow

Arm/Group Title	Non-Electric Infant Warmer
Arm/Group 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]).
Period Title: Overall Study
STARTED	130
COMPLETED	129
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Non-Electric Infant Warmer
Arm/Group 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]).
Overall Participants	130
Age, Customized (Count of Participants)
<37 weeks Gestation	21 16.2%
>=37 weeks gestation	51 39.2%
Missing/Not Known	58 44.6%
Sex/Gender, Customized (Count of Participants)
Sex/Gender Unknown	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
Rwanda	130 100%
Birth Weight (Count of Participants)
≥2500 g	15 11.5%
1501 g to ≤2500 g	96 73.8%
1001 g to ≤1500 g	15 11.5%
≤1000 g	1 0.8%
Missing	3 2.3%
Age at First Encounter (Count of Participants)
1-7 days	29 22.3%
8-31 days	16 12.3%
32 days or more	8 6.2%
On Birthday	77 59.2%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Non-Electric Infant Warmer
Arm/Group 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]).
Measure Participants	130
Measure Encounters	204
Successfully reaches/maintains healthy temperature	179
Fails to reach/maintain healthy temperature	4
Not recorded	21

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Non-Electric Infant Warmer
Arm/Group 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]).
Measure Participants	130
Measure Encounters	204
Deviation from recommended use	0
No deviation from recommended use	204

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Non-Electric Infant Warmer
Arm/Group 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]).
Measure Participants	103
Measure Infant Warmers	12
Showed wear and tear	5
No wear and tear	7

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Zero participants were analyzed as the investigators ultimately decided not collect qualitative data.

Arm/Group Title	Non-Electric Infant Warmer
Arm/Group 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]).
Measure Participants	0

Adverse Events

Time Frame	3 years
Arm/Group Title	Non-Electric Infant Warmer
Arm/Group 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]).
All Cause Mortality
	Non-Electric Infant Warmer
	Affected / at Risk (%)	# Events
Total	0/130 (0%)
Serious Adverse Events
	Non-Electric Infant Warmer
	Affected / at Risk (%)	# Events
Total	0/130 (0%)
Other (Not Including Serious) Adverse Events
	Non-Electric Infant Warmer
	Affected / at Risk (%)	# Events
Total	0/130 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.