<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/NCT02189759</url>
  </required_header>
  <id_info>
    <org_study_id>UAB Neo 012</org_study_id>
    <nct_id>NCT02189759</nct_id>
  </id_info>
  <brief_title>Kangaroo Mother Care to Prevent Hypothermia in Term Infants</brief_title>
  <official_title>A Randomized Trial of Kangaroo Mother Care to Prent Neonatal Hypothermia - Trials 2A &amp; 2 B</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination&#xD;
      with existing WHO thermoregulation care will reduce the incidence of moderate hypothermia&#xD;
      (32-36 degrees C) or severe hypothermia (&lt;32.0 degrees C) in term infants (greater than or&#xD;
      equal to 37 weeks of gestational age) when compared with routine WHO thermoregulation alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination&#xD;
      with existing World Health Organization (WHO) thermoregulation care (warm delivery rooms,&#xD;
      immediate drying after birth, KMC whenever possible, early and exclusive breastfeeding,&#xD;
      postponement of bathing and weighing, appropriate bundling, and use of air incubator, radiant&#xD;
      warmer, or heat mattress if the neonate develops hypothermia) will reduce the incidence of&#xD;
      moderate hypothermia (32-36 degrees C) or severe hypothermia (&lt;32.0 degrees C) in term&#xD;
      infants (greater than or equal to weeks of gestational age) when compared with routine WHO&#xD;
      thermoregulation alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Infants With Axillary Temperature &lt;36.0 Degrees Celsius</measure>
    <time_frame>Time of birth to 1 hour</time_frame>
    <description>Temperature taken per axilla using digital thermometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Infants With Axillary Temperature &lt; 36.0 Degrees Celsius at Discharge</measure>
    <time_frame>At discharge or 24 hours after birth (whichever is first)</time_frame>
    <description>Temperature taken per axilla using diigital thermometer at Discharge or 24hrs after birth</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number Infants Admitted to the Neonatal Intensive Care Unit</measure>
    <time_frame>Duration of hospitalization-an average of 2 weeks</time_frame>
    <description>Any admission to the neonatal intensive care unit for higher level care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Kangaroo Mother Care</measure>
    <time_frame>Duration of hospitalization-an average of 2 weeks</time_frame>
    <description>Skin to skin contact between baby and mother</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">375</enrollment>
  <condition>Hypothermia</condition>
  <condition>Newborn</condition>
  <arm_group>
    <arm_group_label>Continuous Kangaroo Mother Care to one hour after birth</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In addition to standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia, the infants will receive continuous KMC most of the time possible from birth to one hour after birth.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Kangaroo Mother Care to one hour after birth</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Infants will receive standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia from birth to 1 hour after birth.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuous Kangaroo Mother Care to discharge</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In addition to standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia, the infants will receive continuous KMC most of the time possible from one hour after birth to discharge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Kangaroo Mother Care to discharge</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Infants will receive standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia from 1 hour after birth to discharge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Continuous Kangaroo Mother Care to one hour after birth</intervention_name>
    <description>Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (&gt;38 degrees Celsius), the infant will be removed from KMC and routine bundling practices will be used. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age.</description>
    <arm_group_label>Continuous Kangaroo Mother Care to one hour after birth</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Kangaroo Mother Care to one hour after birth</intervention_name>
    <description>Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (&gt;38 degrees Celsius), the infant will receive standard care which may include removal from KMC and use of routine bundling practices. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age.</description>
    <arm_group_label>Standard Kangaroo Mother Care to one hour after birth</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Continuous Kangaroo Mother Care to discharge</intervention_name>
    <description>Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (&gt;38 degrees Celsius), the infant will be removed from KMC and routine bundling practices will be used. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age and again at discharge or 24 hours whichever occurs first.</description>
    <arm_group_label>Continuous Kangaroo Mother Care to discharge</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Kangaroo Mother Care to discharge</intervention_name>
    <description>Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (&gt;38 degrees Celsius), standard treatment will be given which may include removal from KMC and use of routine bundling practices. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age and again at discharge or 24 hours whichever occurs first.</description>
    <arm_group_label>Standard Kangaroo Mother Care to discharge</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Estimated gestational age greater than or equal to 37 weeks&#xD;
&#xD;
          -  Delivery in the hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abdominal wall defect or myelomeningocele&#xD;
&#xD;
          -  Major congenital anomalies&#xD;
&#xD;
          -  Blistering skin disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Minute</minimum_age>
    <maximum_age>2 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Waldemar A Carlo, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Manimaran Ramani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Teaching Hospital</name>
      <address>
        <city>Lusaka</city>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Zambia</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <results_first_submitted>February 17, 2017</results_first_submitted>
  <results_first_submitted_qc>April 4, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 19, 2017</results_first_posted>
  <last_update_submitted>April 4, 2017</last_update_submitted>
  <last_update_submitted_qc>April 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Manimaran Ramani, MD</investigator_full_name>
    <investigator_title>Assistant Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Hypothermia</keyword>
  <keyword>Hyperthermia</keyword>
  <keyword>Kangaroo Mother Care</keyword>
  <keyword>Newborn</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothermia</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Continuous Kangaroo Mother Care to One Hour After Birth</title>
          <description>Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in</description>
        </group>
        <group group_id="P2">
          <title>Standard Kangaroo Mother Care to One Hour After Birth</title>
          <description>Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec</description>
        </group>
        <group group_id="P3">
          <title>Continuous Kangaroo Mother Care to Discharge</title>
          <description>Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (&gt;38 degrees Celsius), the</description>
        </group>
        <group group_id="P4">
          <title>Standard Kangaroo Mother Care to Discharge</title>
          <description>Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (&gt;38 degrees Celsius), standard treatment will be given which may include remova</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="102"/>
                <participants group_id="P2" count="101"/>
                <participants group_id="P3" count="83"/>
                <participants group_id="P4" count="89"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="102"/>
                <participants group_id="P2" count="101"/>
                <participants group_id="P3" count="81"/>
                <participants group_id="P4" count="84"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Continuous Kangaroo Mother Care to One Hour After Birth</title>
          <description>Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in</description>
        </group>
        <group group_id="B2">
          <title>Standard Kangaroo Mother Care to One Hour After Birth</title>
          <description>Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec</description>
        </group>
        <group group_id="B3">
          <title>Continuous Kangaroo Mother Care to Discharge</title>
          <description>Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (&gt;38 degrees Celsius), the</description>
        </group>
        <group group_id="B4">
          <title>Standard Kangaroo Mother Care to Discharge</title>
          <description>Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (&gt;38 degrees Celsius), standard treatment will be given which may include remova</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="102"/>
            <count group_id="B2" value="101"/>
            <count group_id="B3" value="81"/>
            <count group_id="B4" value="84"/>
            <count group_id="B5" value="368"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="81"/>
                    <measurement group_id="B4" value="84"/>
                    <measurement group_id="B5" value="368"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1" lower_limit=".5" upper_limit="1"/>
                    <measurement group_id="B2" value="1" lower_limit=".5" upper_limit="1"/>
                    <measurement group_id="B3" value="6" lower_limit="1" upper_limit="12"/>
                    <measurement group_id="B4" value="6" lower_limit="1" upper_limit="12"/>
                    <measurement group_id="B5" value="6" lower_limit="1" upper_limit="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="42"/>
                    <measurement group_id="B4" value="46"/>
                    <measurement group_id="B5" value="194"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="38"/>
                    <measurement group_id="B5" value="174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="81"/>
                    <measurement group_id="B4" value="84"/>
                    <measurement group_id="B5" value="368"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Zambia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="81"/>
                    <measurement group_id="B4" value="84"/>
                    <measurement group_id="B5" value="368"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Infants With Axillary Temperature &lt;36.0 Degrees Celsius</title>
        <description>Temperature taken per axilla using digital thermometer</description>
        <time_frame>Time of birth to 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Continuous Kangaroo Mother Care to One Hour After Birth</title>
            <description>Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in</description>
          </group>
          <group group_id="O2">
            <title>Standard Kangaroo Mother Care to One Hour After Birth</title>
            <description>Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Infants With Axillary Temperature &lt;36.0 Degrees Celsius</title>
          <description>Temperature taken per axilla using digital thermometer</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                    <measurement group_id="O2" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Infants With Axillary Temperature &lt; 36.0 Degrees Celsius at Discharge</title>
        <description>Temperature taken per axilla using diigital thermometer at Discharge or 24hrs after birth</description>
        <time_frame>At discharge or 24 hours after birth (whichever is first)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Continuous Kangaroo Mother Care to Discharge</title>
            <description>Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (&gt;38 degrees Celsius), the</description>
          </group>
          <group group_id="O2">
            <title>Standard Kangaroo Mother Care to Discharge</title>
            <description>Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (&gt;38 degrees Celsius), standard treatment will be given which may include remova</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Infants With Axillary Temperature &lt; 36.0 Degrees Celsius at Discharge</title>
          <description>Temperature taken per axilla using diigital thermometer at Discharge or 24hrs after birth</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number Infants Admitted to the Neonatal Intensive Care Unit</title>
        <description>Any admission to the neonatal intensive care unit for higher level care</description>
        <time_frame>Duration of hospitalization-an average of 2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Continuous Kangaroo Mother Care to One Hour After Birth</title>
            <description>Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in</description>
          </group>
          <group group_id="O2">
            <title>Standard Kangaroo Mother Care to One Hour After Birth</title>
            <description>Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec</description>
          </group>
          <group group_id="O3">
            <title>Continuous Kangaroo Mother Care to Discharge</title>
            <description>Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (&gt;38 degrees Celsius), the</description>
          </group>
          <group group_id="O4">
            <title>Standard Kangaroo Mother Care to Discharge</title>
            <description>Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (&gt;38 degrees Celsius), standard treatment will be given which may include remova</description>
          </group>
        </group_list>
        <measure>
          <title>Number Infants Admitted to the Neonatal Intensive Care Unit</title>
          <description>Any admission to the neonatal intensive care unit for higher level care</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="81"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Kangaroo Mother Care</title>
        <description>Skin to skin contact between baby and mother</description>
        <time_frame>Duration of hospitalization-an average of 2 weeks</time_frame>
        <population>Infants in &quot;Standard Kanagroo Mother Care to one hour after birth&quot; and &quot;Standard Kangaroo Mother care to discharge&quot; groups received kangaroo mother care only during breastfeeding</population>
        <group_list>
          <group group_id="O1">
            <title>Continuous Kangaroo Mother Care to One Hour After Birth</title>
            <description>Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in</description>
          </group>
          <group group_id="O2">
            <title>Standard Kangaroo Mother Care to One Hour After Birth</title>
            <description>Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec</description>
          </group>
          <group group_id="O3">
            <title>Continuous Kangaroo Mother Care to Discharge</title>
            <description>Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (&gt;38 degrees Celsius), the</description>
          </group>
          <group group_id="O4">
            <title>Standard Kangaroo Mother Care to Discharge</title>
            <description>Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (&gt;38 degrees Celsius), standard treatment will be given which may include remova</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Kangaroo Mother Care</title>
          <description>Skin to skin contact between baby and mother</description>
          <population>Infants in &quot;Standard Kanagroo Mother Care to one hour after birth&quot; and &quot;Standard Kangaroo Mother care to discharge&quot; groups received kangaroo mother care only during breastfeeding</population>
          <units>Hours</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="81"/>
                <count group_id="O4" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".6" spread=".25"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                    <measurement group_id="O3" value="7" spread="4"/>
                    <measurement group_id="O4" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed</desc>
      <group_list>
        <group group_id="E1">
          <title>Continuous Kangaroo Mother Care to One Hour After Birth</title>
          <description>Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in</description>
        </group>
        <group group_id="E2">
          <title>Standard Kangaroo Mother Care to One Hour After Birth</title>
          <description>Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec</description>
        </group>
        <group group_id="E3">
          <title>Continuous Kangaroo Mother Care to Discharge</title>
          <description>Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (&gt;38 degrees Celsius), the</description>
        </group>
        <group group_id="E4">
          <title>Standard Kangaroo Mother Care to Discharge</title>
          <description>Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (&gt;38 degrees Celsius), standard treatment will be given which may include remova</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Manimaran Ramani</name_or_title>
      <organization>University of Alabama at Birmingham</organization>
      <phone>2054731425</phone>
      <email>mramani@peds.uab.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/NCT02189759
org study id: UAB Neo 012
nct id: NCT02189759
lead sponsor: 
has dmc: Yes
The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination
      with existing WHO thermoregulation care will reduce the incidence of moderate hypothermia
      (32-36 degrees C) or severe hypothermia (<32.0 degrees C) in term infants (greater than or
      equal to 37 weeks of gestational age) when compared with routine WHO thermoregulation alone.
The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination
      with existing World Health Organization (WHO) thermoregulation care (warm delivery rooms,
      immediate drying after birth, KMC whenever possible, early and exclusive breastfeeding,
      postponement of bathing and weighing, appropriate bundling, and use of air incubator, radiant
      warmer, or heat mattress if the neonate develops hypothermia) will reduce the incidence of
      moderate hypothermia (32-36 degrees C) or severe hypothermia (<32.0 degrees C) in term
      infants (greater than or equal to weeks of gestational age) when compared with routine WHO
      thermoregulation alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Infants With Axillary Temperature <36.0 Degrees Celsius
time frame: Time of birth to 1 hour
description: Temperature taken per axilla using digital thermometer
measure: Number of Infants With Axillary Temperature < 36.0 Degrees Celsius at Discharge
time frame: At discharge or 24 hours after birth (whichever is first)
description: Temperature taken per axilla using diigital thermometer at Discharge or 24hrs after birth
measure: Number Infants Admitted to the Neonatal Intensive Care Unit
time frame: Duration of hospitalization-an average of 2 weeks
description: Any admission to the neonatal intensive care unit for higher level care
measure: Duration of Kangaroo Mother Care
time frame: Duration of hospitalization-an average of 2 weeks
description: Skin to skin contact between baby and mother
arm group label: Continuous Kangaroo Mother Care to one hour after birth
arm group type: Active Comparator
description: In addition to standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia, the infants will receive continuous KMC most of the time possible from birth to one hour after birth.
arm group label: Standard Kangaroo Mother Care to one hour after birth
arm group type: Sham Comparator
description: Infants will receive standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia from birth to 1 hour after birth.
arm group label: Continuous Kangaroo Mother Care to discharge
arm group type: Active Comparator
description: In addition to standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia, the infants will receive continuous KMC most of the time possible from one hour after birth to discharge.
arm group label: Standard Kangaroo Mother Care to discharge
arm group type: Sham Comparator
description: Infants will receive standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia from 1 hour after birth to discharge.
intervention type: Other
intervention name: Continuous Kangaroo Mother Care to one hour after birth
description: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the infant will be removed from KMC and routine bundling practices will be used. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age.
arm group label: Continuous Kangaroo Mother Care to one hour after birth
intervention type: Other
intervention name: Standard Kangaroo Mother Care to one hour after birth
description: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the infant will receive standard care which may include removal from KMC and use of routine bundling practices. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age.
arm group label: Standard Kangaroo Mother Care to one hour after birth
intervention type: Other
intervention name: Continuous Kangaroo Mother Care to discharge
description: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the infant will be removed from KMC and routine bundling practices will be used. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age and again at discharge or 24 hours whichever occurs first.
arm group label: Continuous Kangaroo Mother Care to discharge
intervention type: Other
intervention name: Standard Kangaroo Mother Care to discharge
description: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include removal from KMC and use of routine bundling practices. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age and again at discharge or 24 hours whichever occurs first.
arm group label: Standard Kangaroo Mother Care to discharge
criteria: 
gender: All
minimum age: 1 Minute
maximum age: 2 Weeks
healthy volunteers: No
last name: Waldemar A Carlo, MD
role: Study Director
affiliation: University of Alabama at Birmingham
last name: Manimaran Ramani, MD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: Zambia
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Manimaran Ramani, MD
investigator title: Assistant Professor of Pediatrics
mesh term: Hypothermia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 