NCT06003140

Efficacy of Celsi Warmer for the Management of Hypothermic Newborns at the Lagos University Teaching Hospital in Lagos, Nigeria

Efficacy of Low-cost Warming Mattress Celsi Warmer for the Management of Hypothermic Newborns at the Lagos University Teaching Hospital in Lagos, Nigeria

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: William Marsh Rice University · Academic / Other
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Not accepted

Summary

The prevalence of hypothermia across low-resource settings is high, especially in countries with high neonatal mortality rates. If left untreated, hypothermia can additionally result in a significant comorbidity, and has been linked to a reduction in the effectiveness of treatment for other newborn conditions. Effective thermal care for hypothermic newborns is not widely available in low-resource settings due to cost of consumables and spare parts. In this study, the research team wish to evaluate the efficacy of a novel neonatal warming mattress in treating hypothermic newborns. Warming mattress, 'Celsi Warmer', has been developed by Rice 360 Institute for Global Health Technologies, in conjunction with African clinicians, to be a robust, low-cost, and easy-to-use warming mattress which can address the challenges of hypothermia. This is a single-arm, non-randomized, prospective intervention study. Up to 90 eligible infants at the neonatal wards of the Lagos University Teaching Hospital will be recruited to evaluate the efficacy of Celsi Warmer in rewarming hypothermic newborns. Infants temperature will be monitored during thermal intervention and the performance of the device will be evaluated. The temperatures of each infant will be compared before, during, and after the intervention.

Conditions

• Neonatal Hypothermia

Interventions

Type	Name	Description
DEVICE	Celsi Warmer	A trained study clinician will attach the Celsi Warmer temperature sensor to the abdomen and secure it with the abdominal belt according to the device's instruction manual (such that the temperature sensor is positioned using a vertical line from the mid-clavicular line and just below the ribs). The time of sensor placement will be recorded.

Timeline

• Start date: 2023-08-15
• Primary completion: 2024-10-21
• Completion: 2024-10-21
• First posted: 2023-08-21
• Last updated: 2024-06-07

Locations

1 site across 1 country: Nigeria