<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/NCT03031431</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00016205</org_study_id>
    <nct_id>NCT03031431</nct_id>
  </id_info>
  <brief_title>Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda</brief_title>
  <official_title>Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Rwanda</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rwandan Biomedical Counsel (RBC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Harvard Medical School (HMS and HSDM)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute for Transformative Technologies (ITT)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Partners in Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothermia contributes to a significant portion of neonatal deaths. Kangaroo mother care&#xD;
      (KMC) is a safe and effective method of warming; however, it is not always feasible, and not&#xD;
      possible in settings such as resuscitation or clinical instability. Electric warmers are the&#xD;
      standard of care in developed countries, but are extremely costly, complicated with risk of&#xD;
      causing both hypo and hyperthermia with misuse, and often not feasible in settings without&#xD;
      stable electricity. Through a multi-institutional collaboration, the investigators have&#xD;
      developed an electricity-free infant warmer. After laboratory based prototype testing for&#xD;
      safety and efficacy, the investigators aim to study the supervised use of the warmer under&#xD;
      routine implementation conditions in a resource-limited setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothermia contributes to a significant portion of neonatal deaths. Kangaroo mother care&#xD;
      (KMC) is a safe and effective method of warming; however, it is not always feasible, and not&#xD;
      possible in settings such as resuscitation or clinical instability. Electric warmers are the&#xD;
      standard of care in developed countries, but are extremely costly, complicated with risk of&#xD;
      causing both hypo and hyperthermia with misuse, and often not feasible in settings without&#xD;
      stable electricity. Through a multi-institutional collaboration, the investigators have&#xD;
      developed an electricity-free infant warmer. After laboratory based prototype testing for&#xD;
      safety and efficacy, the investigators aim to study the supervised use of the warmer under&#xD;
      routine implementation conditions in a resource-limited setting. The primary aim of Phase 1&#xD;
      is to determine if the infant warmer is a safe, effective, usable and functional addition to&#xD;
      KMC. This is planned in a convenience sample of patients in two district hospitals, one in a&#xD;
      relatively warm environment, and one in a colder setting using quantitative methods and&#xD;
      observer audits of usability and functionality. After determination of safety and&#xD;
      effectiveness and making any necessary modifications to the warmer, Phase 2 aims to study the&#xD;
      warmer in rural health centers and transport, as this is where we ultimately aim to use the&#xD;
      electricity free devices due to the limited access to functioning and stable electricity in&#xD;
      these settings. The overall goal of the project is dissemination of the study results, and&#xD;
      ultimately the infant warmer to the district and national level for key policy makers and&#xD;
      stakeholders, as well as globally via publication.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Actual">July 2019</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Temperature/Effectiveness</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The infant warmer will be evaluated on the number of time is able to successfully achieve and maintain a normal body temperature for patients who are hypothermic and those patients at risk of hypothermia because of a &lt; 2.5 kg birth weight or &lt; 35 week gestational age.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Usability</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The investigators will use observation to evaluate the usability of the warmer by assessing whether or not the infant warmer was used in a way that deviated from its recommended use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functionality</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The functionality will be assessed by whether or not there appeared to be wear and tear on the infant warmer based on repeated use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative Survey</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>The same as primary outcome and secondary outcome as described above with the setting being clinic and transport based rather than in a hospital, and with the addition of qualitative questions for mother and nurse regarding infant warmer use.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Hypothermia Neonatal</condition>
  <arm_group>
    <arm_group_label>Non-Electric Infant Warmer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In line with current recommended practice, mothers will be encouraged to provide Kangaroo Mother Care (KMC) whenever possible. If an infant's temp is not rising by ½ degree C per hour with KMC alone, the infant warmer will be offered as an addition by the study team. If the mother is not available for KMC at any time, the infant will be warmed exclusively with the warmer. Bundling in clothes will only be used in addition to the warmer per carer preference. Temp measurement of the infant, warmer, and ambient air will be measured every 15 mins for the first hr, then hrly and as needed for the remainder of use or until warmer endpoint is reached (warmer temp below 36 degrees or phase-change material hardens [soft, semisoft, or hardened]).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non-Electric Infant Warmer</intervention_name>
    <description>Electric warmers are the standard of care in developed countries, but are extremely costly, complicated with risk of causing both hypo and hyperthermia with misuse, and often not feasible in settings without stable electricity. Through a multi-institutional collaboration, the investigators have developed an electricity-free infant warmer.</description>
    <arm_group_label>Non-Electric Infant Warmer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any infant with the following criteria for whom caregiver is not available for&#xD;
             Kangaroo Mother Care, or Kangaroo Mother Care is not adequate (less than ½ degree&#xD;
             Celsius per hour rise in temperature).&#xD;
&#xD;
               1. axillary temperature &lt; 36 degrees C and ≥35 degrees C 1a) If an electric warmer&#xD;
                  is available and the infant's temperature is &lt; 35 degrees C, then the infant&#xD;
                  would start by being warmed on the electric warmer until the infant's temperature&#xD;
                  reaches 36 degrees C, then can start non-electric infant warmer use&#xD;
&#xD;
               2. Infants at-risk for hypothermia (criteria: estimated post-menstrual age of &lt; 35&#xD;
                  weeks or current body weight of &lt; 2.5 kg)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any infant whose family is unwilling to consent to study.&#xD;
&#xD;
          2. Mothers who are critically ill at the time of infant eligibility or deemed not&#xD;
             medically stable by nursing staff to be approached for consent.&#xD;
&#xD;
          3. Any infant with a contraindication to Kangaroo Mother Care (medical instability) and&#xD;
             electrical heating source available.&#xD;
&#xD;
          4. Any infant with initial temperature &lt; 35 degrees C and electrical heating source&#xD;
             available.&#xD;
&#xD;
          5. Infants within the first hour of admission to neonatal unit or first hour of life in&#xD;
             maternity.&#xD;
&#xD;
          6. Infants requiring phototherapy&#xD;
&#xD;
          7. Infants with significant skin condition&#xD;
&#xD;
          8. Infants with Hypoxic Ischemic Encephalopathy (HIE)&#xD;
&#xD;
        Stopping Criteria:&#xD;
&#xD;
        If an electric heating source is available, the infant will be taken off the study and&#xD;
        warmed with an appropriate source of electric heat if the infant:&#xD;
&#xD;
          1. Is hypothermic and temperature decreases on any measurement&#xD;
&#xD;
          2. Is hypothermic and temperature does not begin to rise within 30 minutes&#xD;
&#xD;
          3. Is hypothermic and not heating at a rate of &gt; ½ degree C per hour until temperature is&#xD;
             &gt;36.5 degrees C&#xD;
&#xD;
          4. Has a temperature that falls below 36 degrees C despite maximum exposure to the heat&#xD;
             source&#xD;
&#xD;
          5. Is ever considered to be too severely ill by the medical team to be safely cared for&#xD;
             in the non-electric infant warmer.&#xD;
&#xD;
          6. The warmer will be removed once its temperature drops below 36 degrees, and/or the&#xD;
             phase change material begins to harden.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>3 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne Hansen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr Evrard Nahimana</name>
      <address>
        <city>Rwinkwavu</city>
        <country>Rwanda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Rwanda</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <results_first_submitted>July 3, 2019</results_first_submitted>
  <results_first_submitted_qc>January 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 13, 2020</results_first_posted>
  <last_update_submitted>January 9, 2020</last_update_submitted>
  <last_update_submitted_qc>January 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Anne Hansen</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Hypothermia</keyword>
  <keyword>Infant Warmer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothermia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 14, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03031431/Prot_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Non-Electric Infant Warmer</title>
          <description>In line with current recommended practice, mothers will be encouraged to provide Kangaroo Mother Care (KMC) whenever possible. If an infant's temp is not rising by ½ degree C per hour with KMC alone, the infant warmer will be offered as an addition by the study team. If the mother is not available for KMC at any time, the infant will be warmed exclusively with the warmer. Bundling in clothes will only be used in addition to the warmer per carer preference. Temp measurement of the infant, warmer, and ambient air will be measured every 15 mins for the first hr, then hrly and as needed for the remainder of use or until warmer endpoint is reached (warmer temp below 36 degrees or phase-change material hardens [soft, semisoft, or hardened]).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="130"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="129"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Infant removed by maternal request</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Non-Electric Infant Warmer</title>
          <description>In line with current recommended practice, mothers will be encouraged to provide Kangaroo Mother Care (KMC) whenever possible. If an infant's temp is not rising by ½ degree C per hour with KMC alone, the infant warmer will be offered as an addition by the study team. If the mother is not available for KMC at any time, the infant will be warmed exclusively with the warmer. Bundling in clothes will only be used in addition to the warmer per carer preference. Temp measurement of the infant, warmer, and ambient air will be measured every 15 mins for the first hr, then hrly and as needed for the remainder of use or until warmer endpoint is reached (warmer temp below 36 degrees or phase-change material hardens [soft, semisoft, or hardened]).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="130"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;37 weeks Gestation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=37 weeks gestation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing/Not Known</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <population>Sex/Gender was not obtained or assessed</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Sex/Gender Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Rwanda</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Birth Weight</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>≥2500 g</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1501 g to ≤2500 g</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1001 g to ≤1500 g</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≤1000 g</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age at First Encounter</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>1-7 days</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-31 days</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>32 days or more</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>On Birthday</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Temperature/Effectiveness</title>
        <description>The infant warmer will be evaluated on the number of time is able to successfully achieve and maintain a normal body temperature for patients who are hypothermic and those patients at risk of hypothermia because of a &lt; 2.5 kg birth weight or &lt; 35 week gestational age.</description>
        <time_frame>Up to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-Electric Infant Warmer</title>
            <description>In line with current recommended practice, mothers will be encouraged to provide Kangaroo Mother Care (KMC) whenever possible. If an infant's temp is not rising by ½ degree C per hour with KMC alone, the infant warmer will be offered as an addition by the study team. If the mother is not available for KMC at any time, the infant will be warmed exclusively with the warmer. Bundling in clothes will only be used in addition to the warmer per carer preference. Temp measurement of the infant, warmer, and ambient air will be measured every 15 mins for the first hr, then hrly and as needed for the remainder of use or until warmer endpoint is reached (warmer temp below 36 degrees or phase-change material hardens [soft, semisoft, or hardened]).</description>
          </group>
        </group_list>
        <measure>
          <title>Temperature/Effectiveness</title>
          <description>The infant warmer will be evaluated on the number of time is able to successfully achieve and maintain a normal body temperature for patients who are hypothermic and those patients at risk of hypothermia because of a &lt; 2.5 kg birth weight or &lt; 35 week gestational age.</description>
          <units>Number of infant warmer uses</units>
          <param>Number</param>
          <units_analyzed>Encounters</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Encounters</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="204"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Successfully reaches/maintains healthy temperature</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="179"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fails to reach/maintain healthy temperature</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not recorded</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Usability</title>
        <description>The investigators will use observation to evaluate the usability of the warmer by assessing whether or not the infant warmer was used in a way that deviated from its recommended use.</description>
        <time_frame>Up to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-Electric Infant Warmer</title>
            <description>In line with current recommended practice, mothers will be encouraged to provide Kangaroo Mother Care (KMC) whenever possible. If an infant's temp is not rising by ½ degree C per hour with KMC alone, the infant warmer will be offered as an addition by the study team. If the mother is not available for KMC at any time, the infant will be warmed exclusively with the warmer. Bundling in clothes will only be used in addition to the warmer per carer preference. Temp measurement of the infant, warmer, and ambient air will be measured every 15 mins for the first hr, then hrly and as needed for the remainder of use or until warmer endpoint is reached (warmer temp below 36 degrees or phase-change material hardens [soft, semisoft, or hardened]).</description>
          </group>
        </group_list>
        <measure>
          <title>Usability</title>
          <description>The investigators will use observation to evaluate the usability of the warmer by assessing whether or not the infant warmer was used in a way that deviated from its recommended use.</description>
          <units>Encounters with non-electric warmer</units>
          <param>Number</param>
          <units_analyzed>Encounters</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Encounters</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="204"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Deviation from recommended use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No deviation from recommended use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="204"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Functionality</title>
        <description>The functionality will be assessed by whether or not there appeared to be wear and tear on the infant warmer based on repeated use.</description>
        <time_frame>Up to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-Electric Infant Warmer</title>
            <description>In line with current recommended practice, mothers will be encouraged to provide Kangaroo Mother Care (KMC) whenever possible. If an infant's temp is not rising by ½ degree C per hour with KMC alone, the infant warmer will be offered as an addition by the study team. If the mother is not available for KMC at any time, the infant will be warmed exclusively with the warmer. Bundling in clothes will only be used in addition to the warmer per carer preference. Temp measurement of the infant, warmer, and ambient air will be measured every 15 mins for the first hr, then hrly and as needed for the remainder of use or until warmer endpoint is reached (warmer temp below 36 degrees or phase-change material hardens [soft, semisoft, or hardened]).</description>
          </group>
        </group_list>
        <measure>
          <title>Functionality</title>
          <description>The functionality will be assessed by whether or not there appeared to be wear and tear on the infant warmer based on repeated use.</description>
          <units>infant warmers</units>
          <param>Number</param>
          <units_analyzed>Infant Warmers</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Infant Warmers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Showed wear and tear</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No wear and tear</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Qualitative Survey</title>
        <description>The same as primary outcome and secondary outcome as described above with the setting being clinic and transport based rather than in a hospital, and with the addition of qualitative questions for mother and nurse regarding infant warmer use.</description>
        <time_frame>Up to 1 year</time_frame>
        <population>Zero participants were analyzed as the investigators ultimately decided not collect qualitative data.</population>
        <group_list>
          <group group_id="O1">
            <title>Non-Electric Infant Warmer</title>
            <description>In line with current recommended practice, mothers will be encouraged to provide Kangaroo Mother Care (KMC) whenever possible. If an infant's temp is not rising by ½ degree C per hour with KMC alone, the infant warmer will be offered as an addition by the study team. If the mother is not available for KMC at any time, the infant will be warmed exclusively with the warmer. Bundling in clothes will only be used in addition to the warmer per carer preference. Temp measurement of the infant, warmer, and ambient air will be measured every 15 mins for the first hr, then hrly and as needed for the remainder of use or until warmer endpoint is reached (warmer temp below 36 degrees or phase-change material hardens [soft, semisoft, or hardened]).</description>
          </group>
        </group_list>
        <measure>
          <title>Qualitative Survey</title>
          <description>The same as primary outcome and secondary outcome as described above with the setting being clinic and transport based rather than in a hospital, and with the addition of qualitative questions for mother and nurse regarding infant warmer use.</description>
          <population>Zero participants were analyzed as the investigators ultimately decided not collect qualitative data.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Non-Electric Infant Warmer</title>
          <description>In line with current recommended practice, mothers will be encouraged to provide Kangaroo Mother Care (KMC) whenever possible. If an infant's temp is not rising by ½ degree C per hour with KMC alone, the infant warmer will be offered as an addition by the study team. If the mother is not available for KMC at any time, the infant will be warmed exclusively with the warmer. Bundling in clothes will only be used in addition to the warmer per carer preference. Temp measurement of the infant, warmer, and ambient air will be measured every 15 mins for the first hr, then hrly and as needed for the remainder of use or until warmer endpoint is reached (warmer temp below 36 degrees or phase-change material hardens [soft, semisoft, or hardened]).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Anne Hansen</name_or_title>
      <organization>Boston Children's Hospital</organization>
      <phone>(617)-355-6027</phone>
      <email>Anne.Hansen@childrens.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03031431
org study id: IRB-P00016205
nct id: NCT03031431
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Hypothermia contributes to a significant portion of neonatal deaths. Kangaroo mother care
      (KMC) is a safe and effective method of warming; however, it is not always feasible, and not
      possible in settings such as resuscitation or clinical instability. Electric warmers are the
      standard of care in developed countries, but are extremely costly, complicated with risk of
      causing both hypo and hyperthermia with misuse, and often not feasible in settings without
      stable electricity. Through a multi-institutional collaboration, the investigators have
      developed an electricity-free infant warmer. After laboratory based prototype testing for
      safety and efficacy, the investigators aim to study the supervised use of the warmer under
      routine implementation conditions in a resource-limited setting.
Hypothermia contributes to a significant portion of neonatal deaths. Kangaroo mother care
      (KMC) is a safe and effective method of warming; however, it is not always feasible, and not
      possible in settings such as resuscitation or clinical instability. Electric warmers are the
      standard of care in developed countries, but are extremely costly, complicated with risk of
      causing both hypo and hyperthermia with misuse, and often not feasible in settings without
      stable electricity. Through a multi-institutional collaboration, the investigators have
      developed an electricity-free infant warmer. After laboratory based prototype testing for
      safety and efficacy, the investigators aim to study the supervised use of the warmer under
      routine implementation conditions in a resource-limited setting. The primary aim of Phase 1
      is to determine if the infant warmer is a safe, effective, usable and functional addition to
      KMC. This is planned in a convenience sample of patients in two district hospitals, one in a
      relatively warm environment, and one in a colder setting using quantitative methods and
      observer audits of usability and functionality. After determination of safety and
      effectiveness and making any necessary modifications to the warmer, Phase 2 aims to study the
      warmer in rural health centers and transport, as this is where we ultimately aim to use the
      electricity free devices due to the limited access to functioning and stable electricity in
      these settings. The overall goal of the project is dissemination of the study results, and
      ultimately the infant warmer to the district and national level for key policy makers and
      stakeholders, as well as globally via publication.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Temperature/Effectiveness
time frame: Up to 6 months
description: The infant warmer will be evaluated on the number of time is able to successfully achieve and maintain a normal body temperature for patients who are hypothermic and those patients at risk of hypothermia because of a < 2.5 kg birth weight or < 35 week gestational age.
measure: Usability
time frame: Up to 6 months
description: The investigators will use observation to evaluate the usability of the warmer by assessing whether or not the infant warmer was used in a way that deviated from its recommended use.
measure: Functionality
time frame: Up to 6 months
description: The functionality will be assessed by whether or not there appeared to be wear and tear on the infant warmer based on repeated use.
measure: Qualitative Survey
time frame: Up to 1 year
description: The same as primary outcome and secondary outcome as described above with the setting being clinic and transport based rather than in a hospital, and with the addition of qualitative questions for mother and nurse regarding infant warmer use.
arm group label: Non-Electric Infant Warmer
arm group type: Experimental
description: In line with current recommended practice, mothers will be encouraged to provide Kangaroo Mother Care (KMC) whenever possible. If an infant's temp is not rising by ½ degree C per hour with KMC alone, the infant warmer will be offered as an addition by the study team. If the mother is not available for KMC at any time, the infant will be warmed exclusively with the warmer. Bundling in clothes will only be used in addition to the warmer per carer preference. Temp measurement of the infant, warmer, and ambient air will be measured every 15 mins for the first hr, then hrly and as needed for the remainder of use or until warmer endpoint is reached (warmer temp below 36 degrees or phase-change material hardens [soft, semisoft, or hardened]).
intervention type: Device
intervention name: Non-Electric Infant Warmer
description: Electric warmers are the standard of care in developed countries, but are extremely costly, complicated with risk of causing both hypo and hyperthermia with misuse, and often not feasible in settings without stable electricity. Through a multi-institutional collaboration, the investigators have developed an electricity-free infant warmer.
arm group label: Non-Electric Infant Warmer
criteria: 
gender: All
minimum age: N/A
maximum age: 3 Months
healthy volunteers: No
last name: Anne Hansen, MD
role: Principal Investigator
affiliation: Boston Children's Hospital
facility: 
country: Rwanda
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Anne Hansen
investigator title: MD
mesh term: Hypothermia
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 