Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda

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.

Study Overview

• Status: Completed
• Conditions: Hypothermia Neonatal
• Intervention / Treatment: Device: Non-Electric Infant Warmer

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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Rwanda
  • Rwinkwavu, Rwanda
    • Dr Evrard Nahimana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Harvard Medical School (HMS and HSDM); Brigham and Women's Hospital; Ministry of Health, Rwanda; Partners in Health; Rwandan Biomedical Counsel (RBC); Institute for Transformative Technologies (ITT)
• Investigators: Principal Investigator: Anne Hansen, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: December 13, 2016
• First Submitted That Met QC Criteria: January 23, 2017
• First Posted (Estimate): January 25, 2017

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Hypothermia; Infant Warmer
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: IRB-P00016205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO