ThermoSpot Accuracy and Maternal RecognitionThermospotNCT02968524
Evaluation of Thermospot Accuracy in Nigerian Infants Exposed to Ambient Temperature and Validation of Maternal Readings and Responses
An observational study of ThermoSpot Accuracy and Maternal Recognition, run by University of Minnesota at 1 site in Uganda.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 6 weeksHealthy volunteers can take part
- Conditions the study is for
- ThermoSpot Accuracy and Maternal Recognition
- How many people
- 492 participants
- Where
- 1 siteUganda
- Study dates
- Nov 2016to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants 0-6 weeks who are either in the Filtered Sunlight Therapy Study or in the nursery at Bowen University Teaching Hospital.
Who may be able to join
- 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.
Who cannot join
- Parental refusal
- Infants already clinically dehydrated
- Infants that are sunburned.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother's Accuracy in using Thermospot
Will determine mother's ability to read the Thermospot and tell investigators the correct action needed if any
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionApr 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThermoSpot Accuracy and Maternal RecognitionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968524
- Sponsor's protocol ID
- HSR 16_4258
- Acronym
- Thermospot
- Status last verified
- Jan 2018
- First submitted
- 16 Nov 2016
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thermospot Accuracy in Nigerian Infants Exposed to Ambient Temperature and Validation of Maternal Readings and Responses
- ClinicalTrials.gov ID
- NCT02968524
- Acronym / sponsor ID
- Thermospot / HSR 16_4258
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 492 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 6 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants 0-6 weeks who are either in the Filtered Sunlight Therapy Study or in the nursery at Bowen University Teaching Hospital.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Parental refusal
- Infants already clinically dehydrated
- Infants that are sunburned.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ThermoSpot Accuracy and Maternal Recognition, run by University of Minnesota at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother's Accuracy in using Thermospot (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.