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NCT05609292 · ClinicalTrials.gov registry record

Testing A Visual Thermometer in Newborns and Young Infants

A clinical trial, sponsored by University of Minnesota.

Completed
Registry status
120
Enrollment target

NCT05609292: Completed study, sponsored by University of Minnesota.

NCT05609292 is a clinical trial that has completed, run by University of Minnesota. The registered enrollment target is 120 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05609292 has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
120 participants
Enrollment target

Study 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."

Primary Outcome

determining the accuracy of the LCTD in estimating the temperature of infants 0-6 months presenting to the emergency room for treatment

Interventions

  • DEVICE observational

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2022-12-05
Est. Completion 2023-09-30
University of Minnesota

966 total trials

What the finished NCT05609292 record still lists

NCT05609292 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which observational is the first listed.

NCT05609292 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05609292 about?

NCT05609292 is a clinical study titled "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 convention...

What is the current status of trial NCT05609292?

This trial is currently completed. The enrollment target is 120 participants. The study started on 2022-12-05. Estimated completion is 2023-09-30.

What interventions are being tested in trial NCT05609292?

The interventions under investigation include: observational (DEVICE).

Who is sponsoring clinical trial NCT05609292?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT05609292, the US trial registry maintained by the National Library of Medicine. NCT05609292 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.