NCT06000826

Efficacy of Celsi Warmer for the Management of Hypothermic Newborns

Efficacy of a Low-cost Warming Mattress Celsi Warmer for the Management of Hypothermic Newborns

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: William Marsh Rice University · Academic / Other
• Sex: All
• Age: 0 Days – 28 Days
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-09-27
• Primary completion: 2024-08-20
• Completion: 2024-08-20
• First posted: 2023-08-21
• Last updated: 2023-08-22

Locations

1 site across 1 country: Tanzania