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NCT05609292
Testing A Visual Thermometer in Newborns and Young Infants
Conditions: Hyperthermia, Hypothermia
Sex: All
Ages: 0 Months – 6 Months
Healthy volunteers: 1
Enrollment: 120
Sponsor: University of Minnesota
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."
Eligibility Criteria
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 resuscitationany infant for whom physician deems study enrollment would interfere with their careany infant whose parents or caregiver decline enrollmentany nurse or other healthcare provider who declines participationParents who do not understand English, and do not have a medical interpreter at the bedside.
Source: ClinicalTrials.gov (NCT05609292). StuddyBuddy aggregates publicly available trial information.