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Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda

NCT03031431 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2020-01-13

Study results available
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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.

Conditions

  • Hypothermia Neonatal

Interventions

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.

Sponsors & Collaborators

  • Ministry of Health, Rwanda

    collaborator OTHER_GOV

  • Rwandan Biomedical Counsel (RBC)

    collaborator UNKNOWN

  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER

  • Institute for Transformative Technologies (ITT)

    collaborator UNKNOWN

  • Brigham and Women's Hospital

    collaborator OTHER

  • Partners in Health

    collaborator OTHER

  • Boston Children's Hospital

    lead OTHER

Principal Investigators

  • Anne Hansen, MD · Boston Children's Hospital

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2018-12-31
Completion
2019-07-31

Countries

  • Rwanda

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03031431 on ClinicalTrials.gov