<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/NCT02189746</url>
  </required_header>
  <id_info>
    <org_study_id>UAB Neo 011</org_study_id>
    <nct_id>NCT02189746</nct_id>
  </id_info>
  <brief_title>Kangaroo Mother Care to Prevent Hypothermia in Preterm Infants</brief_title>
  <official_title>A Randomized Trial of Kangaroo Mother Care to Prevent Neonatal Hypothermia - Trials 1A &amp; 1B</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 preterm infants (32-36 6/7 weeks&#xD;
      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 preterm&#xD;
      infants (32-36 6/7 weeks of gestational age) when compared with routine WHO thermoregulation&#xD;
      alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</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>Axillary temperature &lt; 36.0 degrees Celsius</measure>
    <time_frame>Time of birth to 1 hour</time_frame>
    <description>Temperature taken per axilla for one minute</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Axillary Temperature &lt; 36.0 degrees Celsius</measure>
    <time_frame>At discharge or 24 hours after birth (whichever is first)</time_frame>
    <description>Temperature taken per axilla for one minute</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Duration of hospitalization-expected average of 4 weeks</time_frame>
    <description>Measure of extremity blood pressure per cuff taken during nursery stay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose</measure>
    <time_frame>Duration of hospitalization-expected average of 4 weeks</time_frame>
    <description>Measure of blood glucose per laboratory value taken per heelstick</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seizure</measure>
    <time_frame>Duration of hospitalization-expected average of 4 weeks</time_frame>
    <description>Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Distress Syndrome (RDS)</measure>
    <time_frame>Duration of hospitalization-expected average of 4 weeks</time_frame>
    <description>Documentation of increased work of breathing, retractions, and need for oxygen, intubation or surfactant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sepsis</measure>
    <time_frame>Duration of hospitalization-expected average of 4 weeks</time_frame>
    <description>Culture proven or culture negative clinically treated course consistent with sepsis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Intensive Care Unit Admission</measure>
    <time_frame>Duration of hospitalization-expected average of 4 weeks</time_frame>
    <description>Any admission to NICU for need for higher level care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>Duration of hospitalization-expected average of 4 weeks</time_frame>
    <description>Cardiorespiratory failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any Axillary Temperature &lt; 36.0 degrees Celsius</measure>
    <time_frame>Duration of hospitalization-expected average of 4 weeks</time_frame>
    <description>Temperature taken per axilla for one minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Kangaroo Mother Care</measure>
    <time_frame>Duration of hospitalization-expected average 4 weeks</time_frame>
    <description>Skin to skin contact between infant and mother</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Hypothermia, Newborn</condition>
  <arm_group>
    <arm_group_label>Continuous Kangaroo Mother Care to 1 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 1 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 1 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 1 hour after birth</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Kangaroo Mother Care to 1 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 1 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 32-36 6/7 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>8 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>January 2018</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>
  <last_update_submitted>January 8, 2018</last_update_submitted>
  <last_update_submitted_qc>January 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2018</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>Newborn</keyword>
  <keyword>Hyperthermia</keyword>
  <keyword>Kangaroo mother care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothermia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02189746
org study id: UAB Neo 011
nct id: NCT02189746
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 preterm infants (32-36 6/7 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 preterm
      infants (32-36 6/7 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: Axillary temperature < 36.0 degrees Celsius
time frame: Time of birth to 1 hour
description: Temperature taken per axilla for one minute
measure: Axillary Temperature < 36.0 degrees Celsius
time frame: At discharge or 24 hours after birth (whichever is first)
description: Temperature taken per axilla for one minute
measure: Blood pressure
time frame: Duration of hospitalization-expected average of 4 weeks
description: Measure of extremity blood pressure per cuff taken during nursery stay.
measure: Blood glucose
time frame: Duration of hospitalization-expected average of 4 weeks
description: Measure of blood glucose per laboratory value taken per heelstick
measure: Seizure
time frame: Duration of hospitalization-expected average of 4 weeks
description: Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.
measure: Respiratory Distress Syndrome (RDS)
time frame: Duration of hospitalization-expected average of 4 weeks
description: Documentation of increased work of breathing, retractions, and need for oxygen, intubation or surfactant
measure: Sepsis
time frame: Duration of hospitalization-expected average of 4 weeks
description: Culture proven or culture negative clinically treated course consistent with sepsis
measure: Neonatal Intensive Care Unit Admission
time frame: Duration of hospitalization-expected average of 4 weeks
description: Any admission to NICU for need for higher level care
measure: Death
time frame: Duration of hospitalization-expected average of 4 weeks
description: Cardiorespiratory failure
measure: Any Axillary Temperature < 36.0 degrees Celsius
time frame: Duration of hospitalization-expected average of 4 weeks
description: Temperature taken per axilla for one minute
measure: Duration of Kangaroo Mother Care
time frame: Duration of hospitalization-expected average 4 weeks
description: Skin to skin contact between infant and mother
arm group label: Continuous Kangaroo Mother Care to 1 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 1 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 1 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 1 hour after birth
intervention type: Other
intervention name: Standard Kangaroo Mother Care to 1 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 1 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: 8 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