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"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."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Infants between the age of 0-6months
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| Name | Affiliation | Role |
|---|---|---|
| Tina Slusher, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D000084462 | Hyperthermia |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| D014947 | Wounds and Injuries |