Testing A Visual Thermometer in Newborns and Young Infants

University of Minnesota (UMN)

Status: Completed

Conditions: Hypothermia; Hyperthermia

Treatments: Device: observational

Study type: Observational

Funder types: Other

Identifiers

NCT05609292

new

Details and patient eligibility

About

"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."

Enrollment: 120 patients

Sex: All

Ages: Under 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Infants 0-6 months (<7 months) presenting to Masonic Emergency Room or inpatient ward, their parent or caregiver who provide verbal consent in English or through a medical interpreter.

Exclusion criteria

• Any infant undergoing active resuscitation
• any infant for whom physician deems study enrollment would interfere with their care
• any infant whose parents or caregiver decline enrollment
• any nurse or other healthcare provider who declines participation
• Parents who do not understand English, and do not have a medical interpreter at the bedside.

Trial design

120 participants in 1 patient group

Study group

Description:

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.

Treatment:

Device: observational