Testing A Visual Thermometer in Newborns and Young Infants

NCT05609292 | Completed DMC

• 1 other identifier: new
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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."

Conditions

Hyperthermia; Hypothermia

Keywords

temperature monitoring; liquid crystal thermometer; hypothermia; hyperthermia; LCTD; infant temperature; infant hyperthermia; infant hypothermia; neonate hyperthermia; neonate hypothermia; neonate temperature

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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

Interventions

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.

Study group

Eligibility Criteria

• Age: 0 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants between the age of 0-6months

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Hyperthermia; Hypothermia

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Tina Slusher, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: December 5, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)