NCT05609292

Testing A Visual Thermometer in Newborns and Young Infants

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 0 Months – 6 Months
• Healthy volunteers: Accepted

Summary

"Severe neonatal jaundice and acute bilirubin encephalopathy are a major cause of death and disability among newborns in LMICs. Filtered sunlight phototherapy (FSPT) was developed, tested and shown to be safe and efficacious in the treatment of jaundice, because effective electric-powered conventional phototherapy is often unavailable10,11. However, FSPT currently requires at least hourly temperature monitoring by healthcare providers (HCPs) because infants receiving FSPT are prone to both hypothermia and hyperthermia. 20 years ago, a liquid crystal thermometer, ThermospotTM (Maternova, Providence, RI) was developed primarily for use in LMICs. It was designed to detect hypothermia and is most sensitive in cold infants and not as sensitive as needed for detecting hyperthermia or fever. The purpose of this pilot study is to determine the accuracy and useability of this LCTD for a wider spectrum of temperatures when used in a large group of infants in a high-income country. If the device performs well in this study, we plan to study it in a low- and middle-income country in Africa."

Conditions

• Hyperthermia
• Hypothermia

Interventions

Type	Name	Description
DEVICE	observational	Infants will get their temperature measured with the liquid crystal thermometer. We are not providing any interventions as they will be in the care of a healthcare team.

Timeline

• Start date: 2022-12-05
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2022-11-08
• Last updated: 2023-11-28

Locations

1 site across 1 country: United States