Testing A Visual Thermometer in Newborns and Young Infants

Sponsor

University of Minnesota (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05609292

Collaborator

(none)

120

Enrollment

2.9

Anticipated Duration (Months)

Study Details

Study Description

Brief 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."

Condition or Disease	Intervention/Treatment	Phase
Hyperthermia Hypothermia	Device: observational

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Case-Crossover

Time Perspective:

Prospective

Official Title:

Testing A Visual Thermometer in Newborns and Young Infants

Anticipated Study Start Date :

Dec 5, 2022

Anticipated Primary Completion Date :

Mar 3, 2023

Anticipated Study Completion Date :

Mar 3, 2023

Arms and Interventions

Arm	Intervention/Treatment
Study group 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.	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.

Arm

Intervention/Treatment

Study group

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.

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.

Outcome Measures

Primary Outcome Measures

Accuracy of the liquid crystal thermometer with measuring a temperature [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Months to 6 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.