Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda

Hypothermia Neonatal Clinical Trial

Official title:

Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031431
• Other study ID #: IRB-P00016205
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: July 2019

Study information

• Verified date: January 2020
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

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

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

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

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia Neonatal

Intervention

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.

Locations

Country	Name	City	State
Rwanda	Dr Evrard Nahimana	Rwinkwavu

Sponsors (7)

Lead Sponsor	Collaborator
Boston Children’s Hospital	Brigham and Women's Hospital, Harvard Medical School, Institute for Transformative Technologies (ITT), Ministry of Health, Rwanda, Partners in Health, Rwandan Biomedical Counsel (RBC)

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 6 months
Secondary	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.	Up to 6 months
Secondary	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.	Up to 6 months
Secondary	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.	Up to 1 year