CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 130 enrolled
Drug / intervention
Non-Electric Infant Warmerdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03031431
NCT03031431N/ACompleted

Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda

Boston Children's Hospital·interventional·Posted Jan 25, 2017·Updated Jan 13, 2020

In Brief

A clinical study evaluating Non-Electric Infant Warmer for Hypothermia Neonatal. Completed, enrolled 130 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 25, 2017
Enrollment StartJul 1, 2016
Primary CompletionDec 1, 2018
Study CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.4 years ago

Interventions

Non-Electric Infant Warmerdevice

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.