<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/NCT03008577</url>
  </required_header>
  <id_info>
    <org_study_id>STU 062016-040</org_study_id>
    <nct_id>NCT03008577</nct_id>
  </id_info>
  <brief_title>Hypothermia and the Effect of Ambient Temperature 2</brief_title>
  <acronym>HEAT2</acronym>
  <official_title>The Impact of Ambient Cesarean Room Temperature on Neonatal Morbidity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Parkland Health and Hospital System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <brief_summary>
    <textblock>
      Neonatal hypothermia is associated with increased risk of mortality as well as multiple&#xD;
      morbidities. The prior HEAT study conducted at our institution showed a difference in&#xD;
      neonatal hypothermia with a change in ambient operating room temperature. The investigator's&#xD;
      objective is to determine if an increase in ambient operative room temperature decreases the&#xD;
      rate of neonatal morbidity. Operating room temperature will be randomized to the current&#xD;
      institutional standard of 20°C (67°F) or a temperature of 24°C (75°F), on a weekly basis for&#xD;
      a period of 1.2 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open, prospective, randomized, single center trial that will address the primary&#xD;
      research question: Does an increase in ambient operating room temperature result in a lower&#xD;
      rate of composite neonatal morbidities? During the 1.2 year study period, the operating room&#xD;
      temperatures on labor and delivery will be adjusted to either the current standard of care&#xD;
      with ambient operating room temperature of 20°C (67°F), or the maximum temperature allowable&#xD;
      per hospital policy in the current operating rooms, which is 24°C (75°F), as determined by&#xD;
      cluster randomization. Composite neonatal morbidities will be recorded including hypoglycemia&#xD;
      necessitating treatment; need for respiratory support within the first 24 hours;&#xD;
      culture-proven sepsis; and mortality. Association of outcomes with the types of passive and&#xD;
      active warming performed will include these morbidities stratified by gestational age as well&#xD;
      as maternal outcomes. In addition, an electronic survey will be administered to the operating&#xD;
      resident physicians to assess their experience with the study conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">May 2018</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>Neonatal Composite Morbidities</measure>
    <time_frame>Up to 24 hours following delivery</time_frame>
    <description>Need for respiratory support, Hypoglycemia necessitating treatment, Culture-proven sepsis; Mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal Recovery Room Dwell Times after Cesarean</measure>
    <time_frame>Up to 48h following delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal Hypothermia</measure>
    <time_frame>Up to 24 hours after delivery</time_frame>
    <description>An oral temperature of less than 36.5C</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5221</enrollment>
  <condition>Hypothermia</condition>
  <condition>Neonatal Outcome</condition>
  <condition>Cesarean Section</condition>
  <arm_group>
    <arm_group_label>Ambient operating room temperature of 67°F</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These patients will have an operating room temperature of 67°F for cesarean delivery, the standard of care at our institution.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ambient operating room temperature of 75°F</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Ambient operating room temperature of 75°F for cesarean delivery, which is closer to World Health Organization recommendations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Change in ambient operating room temperature</intervention_name>
    <arm_group_label>Ambient operating room temperature of 75°F</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All pregnant women and their neonates undergoing cesarean delivery by the Parkland&#xD;
             Hospital Obstetrics Service on the Labor and Delivery unit during the study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria include cases where a cesarean delivery is planned but a&#xD;
             precipitous vaginal delivery occurs, intrauterine fetal demise has been diagnosed&#xD;
             prior to start of surgery, the neonate is noted to have a major congenital anomaly and&#xD;
             resuscitative efforts are not performed (&quot;comfort care only&quot; provided), or a neonatal&#xD;
             temperature is not available.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Parkland Memorial Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03008577
org study id: STU 062016-040
nct id: NCT03008577
lead sponsor: 
collaborator: 
Neonatal hypothermia is associated with increased risk of mortality as well as multiple
      morbidities. The prior HEAT study conducted at our institution showed a difference in
      neonatal hypothermia with a change in ambient operating room temperature. The investigator's
      objective is to determine if an increase in ambient operative room temperature decreases the
      rate of neonatal morbidity. Operating room temperature will be randomized to the current
      institutional standard of 20°C (67°F) or a temperature of 24°C (75°F), on a weekly basis for
      a period of 1.2 years.
This is an open, prospective, randomized, single center trial that will address the primary
      research question: Does an increase in ambient operating room temperature result in a lower
      rate of composite neonatal morbidities? During the 1.2 year study period, the operating room
      temperatures on labor and delivery will be adjusted to either the current standard of care
      with ambient operating room temperature of 20°C (67°F), or the maximum temperature allowable
      per hospital policy in the current operating rooms, which is 24°C (75°F), as determined by
      cluster randomization. Composite neonatal morbidities will be recorded including hypoglycemia
      necessitating treatment; need for respiratory support within the first 24 hours;
      culture-proven sepsis; and mortality. Association of outcomes with the types of passive and
      active warming performed will include these morbidities stratified by gestational age as well
      as maternal outcomes. In addition, an electronic survey will be administered to the operating
      resident physicians to assess their experience with the study conditions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Neonatal Composite Morbidities
time frame: Up to 24 hours following delivery
description: Need for respiratory support, Hypoglycemia necessitating treatment, Culture-proven sepsis; Mortality
measure: Maternal Recovery Room Dwell Times after Cesarean
time frame: Up to 48h following delivery
measure: Maternal Hypothermia
time frame: Up to 24 hours after delivery
description: An oral temperature of less than 36.5C
arm group label: Ambient operating room temperature of 67°F
arm group type: No Intervention
description: These patients will have an operating room temperature of 67°F for cesarean delivery, the standard of care at our institution.
arm group label: Ambient operating room temperature of 75°F
arm group type: Active Comparator
description: Intervention: Ambient operating room temperature of 75°F for cesarean delivery, which is closer to World Health Organization recommendations.
intervention type: Other
intervention name: Change in ambient operating room temperature
arm group label: Ambient operating room temperature of 75°F
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypothermia