<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02968524</url>
  </required_header>
  <id_info>
    <org_study_id>HSR 16_4258</org_study_id>
    <nct_id>NCT02968524</nct_id>
  </id_info>
  <brief_title>Evaluation of Thermospot Accuracy in Nigerian Infants Exposed to Ambient Temperature and Validation of Maternal Readings and Responses</brief_title>
  <acronym>Thermospot</acronym>
  <official_title>Evaluation of Thermospot Accuracy in Nigerian Infants Exposed to Ambient Temperature and Validation of Maternal Readings and Responses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project will focus on testing the accuracy of ThermoSpot -a low-cost, color-based,&#xD;
      temperature indicator in estimating the body temperature of Nigerian babies exposed to&#xD;
      ambient temperature conditions. The particpants will be recruited among babies receiving&#xD;
      Filtered Sunlight Phototherapy (FSPT) at Bowen University Teaching Hospital, Ogbomoso and&#xD;
      other babies in the nursery at Bowen University Teaching Hospital.&#xD;
&#xD;
      There will also be an educational session to teach health workers and mothers about the signs&#xD;
      for hypothermia and hyperthermia on the indicator. Then, the investigators will collect&#xD;
      observational cross-sectional data on random days to see how many of the trained health&#xD;
      workers and mothers were able to accurately recognize and provide appropriate response to&#xD;
      warning signs on the indicator.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ThermoSpot is a liquid crystal display thermometer. It comes as a sticky disc (12mm in&#xD;
      diameter) which can be applied to the skin over the liver, in the armpit, or over the neck&#xD;
      blood vessels of an infant. ThermoSpot was designed as a non-invasive hypothermia indicator&#xD;
      for infants. The device changes color when the baby's core body temperature changes, allowing&#xD;
      it to be understood even by a non-literate parent. It has been tested and proven to&#xD;
      accurately detect hypothermia in Malawi, Nepal and India. However, no large-scale studies&#xD;
      have been performed on babies exposed to ambient temperatures for long periods such as those&#xD;
      under FSPT.&#xD;
&#xD;
      The main objective of the project is to determine whether ThermoSpot can be used to detect&#xD;
      hypothermia or hyperthermia in babies receiving FSPT instead of thermometers. The ability of&#xD;
      a parent to respond in a timely manner to the temperature indicator will help provide&#xD;
      critical information on technical, as well as educational components required for FSPT&#xD;
      scale-up in Nigeria and other resource-limited countries with health worker shortage.&#xD;
&#xD;
      Specific objectives&#xD;
&#xD;
        1. Compare the performance of ThermoSpot in the detection of hypothermia or hyperthermia&#xD;
           with the standard axillary thermometer measurement.&#xD;
&#xD;
        2. Determine if parents are able to correctly interpret the color indicators on ThermoSpot&#xD;
&#xD;
        3. Determine whether parents carry out the appropriate action based on the ThermoSpot&#xD;
           indicator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mother's Accuracy in using Thermospot</measure>
    <time_frame>1 year</time_frame>
    <description>Will determine mother's ability to read the Thermospot and tell investigators the correct action needed if any</description>
  </primary_outcome>
  <enrollment type="Actual">492</enrollment>
  <condition>ThermoSpot Accuracy and Maternal Recognition</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Infants 0-6 weeks who are either in the Filtered Sunlight Therapy Study or in the nursery&#xD;
        at Bowen University Teaching Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Babies under 4 weeks of age receiving FSPT (Infants ≥35wks gestation, or ≥2.2kg if&#xD;
             gestational age is not available, and ≤14 days old at time of study enrollment), for&#xD;
             whom parents or guardians have given consent to participate in the study.&#xD;
&#xD;
          2. Babies under 6 weeks of age in the nursery at Bowen University Teaching Hospital.&#xD;
&#xD;
          3. Parents or guardians of babies receiving FSPT who are interested in learning how to&#xD;
             determine temperature using ThermoSpot and have given consent for their babies to&#xD;
             participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Parental refusal&#xD;
&#xD;
          2. Infants already clinically dehydrated&#xD;
&#xD;
          3. Infants that are sunburned.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Ogomo</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>January 30, 2018</last_update_submitted>
  <last_update_submitted_qc>January 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02968524
org study id: HSR 16_4258
nct id: NCT02968524
lead sponsor: 
has dmc: No
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

        1. Compare the performance of ThermoSpot in the detection of hypothermia or hyperthermia
           with the standard axillary thermometer measurement.

        2. Determine if parents are able to correctly interpret the color indicators on ThermoSpot

        3. Determine whether parents carry out the appropriate action based on the ThermoSpot
           indicator.
observational model: Other
time perspective: Prospective
measure: Mother's Accuracy in using Thermospot
time frame: 1 year
description: Will determine mother's ability to read the Thermospot and tell investigators the correct action needed if any
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Weeks
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Uganda
responsible party type: Sponsor
sharing ipd: No