An observational study in ThermoSpot Accuracy and Maternal Recognition, sponsored by University of Minnesota. Completed at 1 site in Uganda. Open to participants aged Up to 6 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-31.
Sponsored by University of Minnesota · Observational
This project will focus on testing the accuracy of ThermoSpot -a low-cost, color-based, temperature indicator in estimating the body temperature of Nigerian babies exposed to ambient temperature conditions. The particpants will be recruited among babies receiving Filtered Sunlight Phototherapy (FSPT) at Bowen University Teaching Hospital, Ogbomoso and other babies in the nursery at Bowen University Teaching Hospital.
There will also be an educational session to teach health workers and mothers about the signs for hypothermia and hyperthermia on the indicator. Then, the investigators will collect observational cross-sectional data on random days to see how many of the trained health workers and mothers were able to accurately recognize and provide appropriate response to warning signs on the indicator.
ThermoSpot is a liquid crystal display thermometer. It comes as a sticky disc (12mm in diameter) which can be applied to the skin over the liver, in the armpit, or over the neck blood vessels of an infant. ThermoSpot was designed as a non-invasive hypothermia indicator for infants. The device changes color when the baby's core body temperature changes, allowing it to be understood even by a non-literate parent. It has been tested and proven to accurately detect hypothermia in Malawi, Nepal and India. However, no large-scale studies have been performed on babies exposed to ambient temperatures for long periods such as those under FSPT.
The main objective of the project is to determine whether ThermoSpot can be used to detect hypothermia or hyperthermia in babies receiving FSPT instead of thermometers. The ability of a parent to respond in a timely manner to the temperature indicator will help provide critical information on technical, as well as educational components required for FSPT scale-up in Nigeria and other resource-limited countries with health worker shortage.
Specific objectives
University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Infants 0-6 weeks who are either in the Filtered Sunlight Therapy Study or in the nursery at Bowen University Teaching Hospital.
Exclusion Criteria:
Mother's Accuracy in using Thermospot
Will determine mother's ability to read the Thermospot and tell investigators the correct action needed if any
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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