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Efficacy of Celsi Warmer for the Management of Hypothermic Newborns

NCT06000826 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-08-22

No results posted yet for this study

Summary

The purpose of the study is to evaluate the efficacy of a novel low-cost warming device to provide thermal care for newborn babies with hypothermia in low-resource hospitals. During the study, research participants will receive thermal care via the Celsi Warmer. Aside from thermal treatment, research participants will receive the standard of care from the neonatal unit, and will also be closely monitored by study personnel throughout the study. The results from this study will allow us to determine if the Celsi Warmer is an effective tool for warming and monitoring newborns in wards of low-resource hospitals. The research team hopes to demonstrate that the Celsi Warmer is effective for the appropriate treatment of newborn hypothermia in hospitals in low-resource settings.

Conditions

  • Newborn Hypothermia

Interventions

DEVICE

Celsi Warmer

During the study, research participants will receive thermal care via the Celsi Warmer. Aside from thermal treatment, research participants will receive the standard of care from the neonatal unit, and will also be closely monitored by study personnel throughout the study. The results from this study will allow the research team to determine if the Celsi Warmer is an effective tool for warming and monitoring newborns in wards of low-resource hospitals. The research team hopes to demonstrate that the Celsi Warmer is effective for the appropriate treatment of newborn hypothermia in hospitals in low-resource settings.

Sponsors & Collaborators

  • Muhimbili University of Health and Allied Sciences

    collaborator OTHER

  • William Marsh Rice University

    lead OTHER

Principal Investigators

  • Rebecca R Richards-Kortum, PhD · William Marsh Rice University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-27
Primary Completion
2024-08-20
Completion
2024-08-20

Countries

  • Tanzania

Study Locations

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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 NCT06000826 on ClinicalTrials.gov