Completed

NCT Number: NCT02968524

Evaluation of Thermospot Accuracy in Nigerian Infants Exposed to Ambient Temperature and Validation of Maternal Readings and Responses

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.

Completed

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Key information

Conditions

ThermoSpot Accuracy and Maternal Recognition

Age range

Up to 6 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Ogomo, Uganda

About this study

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

Compare the performance of ThermoSpot in the detection of hypothermia or hyperthermia with the standard axillary thermometer measurement.
Determine if parents are able to correctly interpret the color indicators on ThermoSpot
Determine whether parents carry out the appropriate action based on the ThermoSpot indicator.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Babies under 4 weeks of age receiving FSPT (Infants ≥35wks gestation, or ≥2.2kg if gestational age is not available, and ≤14 days old at time of study enrollment), for whom parents or guardians have given consent to participate in the study.
Babies under 6 weeks of age in the nursery at Bowen University Teaching Hospital.
Parents or guardians of babies receiving FSPT who are interested in learning how to determine temperature using ThermoSpot and have given consent for their babies to participate in the study.

Exclusion criteria

Parental refusal
Infants already clinically dehydrated
Infants that are sunburned.

Treatment and study plan

Primary outcomes

Mother's Accuracy in using Thermospot

Time frame: 1 year

Will determine mother's ability to read the Thermospot and tell investigators the correct action needed if any

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Acronym: Thermospot

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Nov 18, 2016
Registry last updated: Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.