Testing A Visual Thermometer in Newborns and Young Infants

Hypothermia Clinical Trial

Official title:

Testing A Visual Thermometer in Newborns and Young Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05609292
• Other study ID #: new
• Status: Completed
• Start date: December 5, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Months to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Fever
• Hyperthermia
• Hypothermia

Intervention

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of the liquid crystal thermometer with measuring a temperature	determining the accuracy of the LCTD in estimating the temperature of infants 0-6 months presenting to the emergency room for treatment	baseline
Primary	Parents/Caregivers and Healthcare provider accuracy in evaluating the infant temperature	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.	baseline