<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/NCT01675830</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00001161</org_study_id>
    <nct_id>NCT01675830</nct_id>
  </id_info>
  <brief_title>Heat Retention Head Wrap Use for Re-warming of Infants Requiring Cardio-Pulmonary Bypass</brief_title>
  <official_title>Heat Retention Head Wrap Use for Re-warming of Infants Requiring Cardio-Pulmonary Bypass</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiology Clinical Research &amp; Regulatory Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardiology Clinical Research &amp; Regulatory Group</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase I descriptive pilot study to determine the feasibility of using the Heat&#xD;
      Retention Head Wrap on infants during the re-warming period following cardio-pulmonary&#xD;
      bypass.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the World Health Organization a body temperature of 36-36.5 degrees Celsius is&#xD;
      mild hypothermia, 32-36 degrees Celsius is moderate hypothermia, and &lt; 32 degrees Celsius is&#xD;
      severe hypothermia.1 Hypothermia can be a major postoperative problem for infants undergoing&#xD;
      cardio-pulmonary bypass (CPB) surgery. During CPB, patients are cooled to decrease metabolism&#xD;
      and protect myocardium and brain. When the repair is completed, the patient is re-warmed as&#xD;
      the temperature of blood in the bypass pump is gradually increased. However, after separation&#xD;
      from the CBP pump, infants consistently experience a temperature drop of 2 to 5 degrees&#xD;
      Celsius.&#xD;
&#xD;
      With head cooling heat dissipates more quickly than with any other body surface. As much as&#xD;
      60% of an infant's body heat can dissipate through an uncovered head, thus leaving patients&#xD;
      at high risk for complications associated with hypothermia. The amount of heat lost to the&#xD;
      environment by newborn infants has a great impact on mortality rates, growth, and energy&#xD;
      maintenance. Major adverse effects from inadvertent hypothermia include myocardial ischemia,&#xD;
      impaired coagulation, prolonged healing, surgical wound infections, and decreased&#xD;
      postoperative comfort.&#xD;
&#xD;
      Nursing participation in the re-warming of patients during CPB surgery is a core&#xD;
      intervention. According to recommendations for perioperative registered nurses the patient&#xD;
      should be at or returning to normothermia at the conclusion of the immediate postoperative&#xD;
      period. Current standards of care for re-warming after CPB do not include any particular type&#xD;
      of head covering. Recently, a new head covering made of biaxial-oriented polyethylene&#xD;
      terephthalate (boPET), called the Heat Retention Head Wrap, has been designed for use with&#xD;
      infants to facilitate warming during the postoperative period (that begins during the&#xD;
      re-warming phase of CBP). The purpose of this study will be to determine the feasibility of&#xD;
      using the Heat Retention Head Wrap on infants during the re-warming period following CPB.&#xD;
&#xD;
      Specific Aims&#xD;
&#xD;
        1. To describe the feasibility of placing a Heat Retention Head Wrap on the infant's head&#xD;
           from the time the re-warming process begins to the time baby arrives in the Cardiac&#xD;
           Intensive Care Unit (CICU) after transfer from the operating room.&#xD;
&#xD;
        2. To characterize the temperature progression from (1) the onset of re-warming, (2)&#xD;
           removal of bypass cannulas, to (3) removal of the rectal temperature probe immediately&#xD;
           before transfer from the OR to the CICU, and (4) upon arrival to the CICU.&#xD;
&#xD;
        3. To identify and describe adverse events observed with use of the Heat Retention Head&#xD;
           Wrap.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <phase>Phase 1</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Head Wrap Feasibility</measure>
    <time_frame>&lt;12 hours</time_frame>
    <description>To describe the feasibility of placing a Thermoregulation Head Wrap on the infant's head from the time the re-warming process begins to the time baby arrives in the Cardiac Intensive Care Unit (CICU) after transfer from the operating room. Likert scale items assessing feasibility of the head wrap will be completed by clinicians upon patient admission to CICU.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Redness, Irritation, and/or Hyperthermia Due to Head Wrap Use</measure>
    <time_frame>These will be assessed upon admission to the CICU, and in 6 hour follow up increments until the last assessment at 72 hours.</time_frame>
    <description>To identify and describe adverse events observed with use of the Thermoregulation Head Wrap.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Impaired Thermoregulation</condition>
  <arm_group>
    <arm_group_label>Head Retention Head Wrap device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects recieved the experimental intervention with the Heat Retention Head Wrap device for during the rewarming phase of cardiopulmonary bypass surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Heat Retention Head Wrap</intervention_name>
    <description>Applied to infant's heads during the rewarming phase of CBP surgery</description>
    <arm_group_label>Head Retention Head Wrap device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing CPB surgery.&#xD;
&#xD;
          -  Weigh ≥ 3 and ≤ 10 kg.&#xD;
&#xD;
          -  Cooled to 24-30 degrees Celsius.&#xD;
&#xD;
          -  Head circumferences between 33-48 cm.&#xD;
&#xD;
          -  Scalp free of skin lesions such as reddened areas, ulcerations, abrasions, burns, and&#xD;
             hemangiomas.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Require cooling below 24 degrees Celsius at any point during CPB surgery.&#xD;
&#xD;
          -  Weigh less than 3 kg or more than that 10kg.&#xD;
&#xD;
          -  Are premature or &lt; 37 weeks corrected gestational age.&#xD;
&#xD;
          -  Have a head circumference smaller than 33 cm or larger than 48 cm.&#xD;
&#xD;
          -  Have a known or previously diagnosed neurological trauma, malignant hyperthermia,&#xD;
             stroke, seizure, VP shunt, evidence of scalp lesions, or other known comorbidity.&#xD;
&#xD;
          -  Have hair braided close to the scalp.&#xD;
&#xD;
          -  Infants with known allergy or sensitivity to polyethylene terephthalate (known as&#xD;
             Mylar)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>1 Year</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen Sakakeeny, BSN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <results_first_submitted>February 11, 2015</results_first_submitted>
  <results_first_submitted_qc>February 11, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 26, 2015</results_first_posted>
  <last_update_submitted>March 11, 2015</last_update_submitted>
  <last_update_submitted_qc>March 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Head Wrap Device</title>
          <description>Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Head Wrap Device</title>
          <description>Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </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="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>weeks</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17.4" lower_limit="4.3" upper_limit="47.8"/>
                  </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="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Head Wrap Feasibility</title>
        <description>To describe the feasibility of placing a Thermoregulation Head Wrap on the infant's head from the time the re-warming process begins to the time baby arrives in the Cardiac Intensive Care Unit (CICU) after transfer from the operating room. Likert scale items assessing feasibility of the head wrap will be completed by clinicians upon patient admission to CICU.</description>
        <time_frame>&lt;12 hours</time_frame>
        <population>Percentage of respondents that agree device is easy to use</population>
        <group_list>
          <group group_id="O1">
            <title>Head Wrap Device</title>
            <description>Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB</description>
          </group>
        </group_list>
        <measure>
          <title>Head Wrap Feasibility</title>
          <description>To describe the feasibility of placing a Thermoregulation Head Wrap on the infant's head from the time the re-warming process begins to the time baby arrives in the Cardiac Intensive Care Unit (CICU) after transfer from the operating room. Likert scale items assessing feasibility of the head wrap will be completed by clinicians upon patient admission to CICU.</description>
          <population>Percentage of respondents that agree device is easy to use</population>
          <units>percentage of respondents</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Redness, Irritation, and/or Hyperthermia Due to Head Wrap Use</title>
        <description>To identify and describe adverse events observed with use of the Thermoregulation Head Wrap.</description>
        <time_frame>These will be assessed upon admission to the CICU, and in 6 hour follow up increments until the last assessment at 72 hours.</time_frame>
        <population>Number of adverse events observed</population>
        <group_list>
          <group group_id="O1">
            <title>Head Wrap Device</title>
            <description>Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB</description>
          </group>
        </group_list>
        <measure>
          <title>Redness, Irritation, and/or Hyperthermia Due to Head Wrap Use</title>
          <description>To identify and describe adverse events observed with use of the Thermoregulation Head Wrap.</description>
          <population>Number of adverse events observed</population>
          <units>adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>72 hours following application of the head wrap device</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Head Wrap Device</title>
          <description>Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </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="10"/>
              </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>
    <limitations_and_caveats>Investigators could not account for differences in the room temperature, heated and humidified gases, CPB regulation, regulation of forced air warming system, warming of IV fluids, and temperature of irrigation solutions in the OR.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Karen Sakakeeny</name_or_title>
      <organization>Boston Children's Hospital</organization>
      <phone>617-355-6369</phone>
      <email>Karen.Sakakeeny@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/NCT01675830
org study id: IRB-P00001161
nct id: NCT01675830
lead sponsor: 
has dmc: Yes
This is a phase I descriptive pilot study to determine the feasibility of using the Heat
      Retention Head Wrap on infants during the re-warming period following cardio-pulmonary
      bypass.
According to the World Health Organization a body temperature of 36-36.5 degrees Celsius is
      mild hypothermia, 32-36 degrees Celsius is moderate hypothermia, and < 32 degrees Celsius is
      severe hypothermia.1 Hypothermia can be a major postoperative problem for infants undergoing
      cardio-pulmonary bypass (CPB) surgery. During CPB, patients are cooled to decrease metabolism
      and protect myocardium and brain. When the repair is completed, the patient is re-warmed as
      the temperature of blood in the bypass pump is gradually increased. However, after separation
      from the CBP pump, infants consistently experience a temperature drop of 2 to 5 degrees
      Celsius.

      With head cooling heat dissipates more quickly than with any other body surface. As much as
      60% of an infant's body heat can dissipate through an uncovered head, thus leaving patients
      at high risk for complications associated with hypothermia. The amount of heat lost to the
      environment by newborn infants has a great impact on mortality rates, growth, and energy
      maintenance. Major adverse effects from inadvertent hypothermia include myocardial ischemia,
      impaired coagulation, prolonged healing, surgical wound infections, and decreased
      postoperative comfort.

      Nursing participation in the re-warming of patients during CPB surgery is a core
      intervention. According to recommendations for perioperative registered nurses the patient
      should be at or returning to normothermia at the conclusion of the immediate postoperative
      period. Current standards of care for re-warming after CPB do not include any particular type
      of head covering. Recently, a new head covering made of biaxial-oriented polyethylene
      terephthalate (boPET), called the Heat Retention Head Wrap, has been designed for use with
      infants to facilitate warming during the postoperative period (that begins during the
      re-warming phase of CBP). The purpose of this study will be to determine the feasibility of
      using the Heat Retention Head Wrap on infants during the re-warming period following CPB.

      Specific Aims

        1. To describe the feasibility of placing a Heat Retention Head Wrap on the infant's head
           from the time the re-warming process begins to the time baby arrives in the Cardiac
           Intensive Care Unit (CICU) after transfer from the operating room.

        2. To characterize the temperature progression from (1) the onset of re-warming, (2)
           removal of bypass cannulas, to (3) removal of the rectal temperature probe immediately
           before transfer from the OR to the CICU, and (4) upon arrival to the CICU.

        3. To identify and describe adverse events observed with use of the Heat Retention Head
           Wrap.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Head Wrap Feasibility
time frame: <12 hours
description: To describe the feasibility of placing a Thermoregulation Head Wrap on the infant's head from the time the re-warming process begins to the time baby arrives in the Cardiac Intensive Care Unit (CICU) after transfer from the operating room. Likert scale items assessing feasibility of the head wrap will be completed by clinicians upon patient admission to CICU.
measure: Redness, Irritation, and/or Hyperthermia Due to Head Wrap Use
time frame: These will be assessed upon admission to the CICU, and in 6 hour follow up increments until the last assessment at 72 hours.
description: To identify and describe adverse events observed with use of the Thermoregulation Head Wrap.
arm group label: Head Retention Head Wrap device
arm group type: Experimental
description: All subjects recieved the experimental intervention with the Heat Retention Head Wrap device for during the rewarming phase of cardiopulmonary bypass surgery.
intervention type: Device
intervention name: Heat Retention Head Wrap
description: Applied to infant's heads during the rewarming phase of CBP surgery
arm group label: Head Retention Head Wrap device
criteria: 
gender: All
minimum age: 1 Day
maximum age: 1 Year
healthy volunteers: No
last name: Karen Sakakeeny, BSN
role: Principal Investigator
affiliation: Boston Children's Hospital
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Investigators could not account for differences in the room temperature, heated and humidified gases, CPB regulation, regulation of forced air warming system, warming of IV fluids, and temperature of irrigation solutions in the OR.
point of contact: 