Testing A Visual Thermometer in Newborns and Young Infants

"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."

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hyperthermia Body Temperature Changes Heat Stress Disorders Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

0 month–6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observational

Device

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.

Primary outcomes

Accuracy of the liquid crystal thermometer with measuring a temperature

Time frame: baseline

determining the accuracy of the LCTD in estimating the temperature of infants 0-6 months presenting to the emergency room for treatment
Parents/Caregivers and Healthcare provider accuracy in evaluating the infant temperature

Time frame: baseline

Our secondary endpoint is determining parents/caregivers and healthcare provider accuracy in evaluating the temperature of their infant or the infant they are caring for and determining the category of the temperature.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Nov 8, 2022
Registry last updated: Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed