Clinical trial NCT03031431: Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda
Official title: Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia Neonatal
Keywords: Hypothermia
Infant Warmer
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Rwanda
name: Rwandan Biomedical Counsel (RBC)
name: Harvard Medical School (HMS and HSDM)
name: Institute for Transformative Technologies (ITT)
name: Brigham and Women's Hospital
name: Partners in Health
First posted: 2017-01-25
Enrollment: 130
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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).

  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.

Primary outcomes:
measure: Temperature/Effectiveness
timeFrame: Up to 6 months
Secondary outcomes:
measure: Usability
timeFrame: Up to 6 months
measure: Functionality
timeFrame: Up to 6 months
measure: Qualitative Survey
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Rwinkwavu
country: Rwanda
facility: Dr Evrard Nahimana
Study officials:
affiliation: Boston Children's Hospital
name: Anne Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References: