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Trial of a Non Electric Infant Warmer for Prevention and Treatment of Hypothermia in Rwanda

NCT03890211 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3179

Last updated 2021-02-11

No results posted yet for this study

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, for example 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 reliable in settings without stable electricity. After two encouraging pilot studies totaling 204 uses in 2 district hospitals and 4 health centers in rural Rwanda, the investigators aim to further study the warmer in a stepped wedge prospective controlled trial in hospital setting to assess safety and efficacy of the Infant Warmer based on clinical observation and feasibility based on observer audits.

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

  • Partners in Health

    collaborator OTHER

  • Rwanda National Ethics Committee (RNEC)

    collaborator UNKNOWN

  • Lawrence Berkeley National Laboratory

    collaborator UNKNOWN

  • Boston Children's Hospital

    lead OTHER

Principal Investigators

  • Anne Hansen, MD, MPH · Boston Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-11
Primary Completion
2020-07-19
Completion
2022-01-01

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 NCT03890211 on ClinicalTrials.gov