N/A
N=130
Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda
Hypothermia Neonatal
Bottom Line
View on ClinicalTrials.gov: NCT03031431 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Temperature/Effectiveness — 179; 4; 21 Number of infant warmer uses
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Non-Electric Infant Warmer (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Temperature/Effectiveness |
179; 4; 21 | — |
| SECONDARY Usability |
0; 204 | — |
| SECONDARY Functionality |
5; 7 | — |
| SECONDARY Qualitative Survey |
— | — |
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.
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).
- axillary temperature ½ degree C per hour until temperature is >36.5 degrees C
- Has a temperature that falls below 36 degrees C despite maximum exposure to the heat source
- 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 36 degrees, and/or the phase change material begins to harden.
Data sourced from ClinicalTrials.gov (NCT03031431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.