<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/NCT03028818</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS 209929</org_study_id>
    <nct_id>NCT03028818</nct_id>
  </id_info>
  <brief_title>Fever Observational Study</brief_title>
  <official_title>An Observational Study of the Epidemiology of Fever Due to Infection in Critically Ill Children Following an Unplanned Admission to a Paediatric Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intensive Care National Audit &amp; Research Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institute of Child Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Paediatric Intensive Care Audit Network (PICANet)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Great Ormond Street Hospital for Children NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Intensive Care National Audit &amp; Research Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To inform the feasibility of conducting a study to test different temperature thresholds at&#xD;
      which clinicians deliver interventions to reduce fever (i.e. antipyretic interventions) in&#xD;
      critically ill children with fever due to infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fever (high temperature) is a normal bodily response to an infection, which has shown to have&#xD;
      a beneficial effect in humans with chickenpox, malaria and rhinovirus infections. In children&#xD;
      it has been recommended by the National Institute for Health and Care Excellence not to cool&#xD;
      down the child using drugs or physical methods such as a cooling mat, with the sole aim to&#xD;
      reducing the child's temperature. However, this recommendation is not aimed at the management&#xD;
      of critically ill children, to which there is uncertainty around use of cooling interventions&#xD;
      when considering the advantages of a fever in defending the body against viruses and bacteria&#xD;
      during critical illness, and weighing that up with the possible negative physiological&#xD;
      consequences of a high fever e.g. increased metabolic rate.&#xD;
&#xD;
      Observational studies show that the treatment of fever in critically ill children is&#xD;
      inconsistent. There is a lack of robust data to guide antipyretic intervention, with&#xD;
      clinicians usually starting fever management at around 37.5°C. Evidence is emerging that&#xD;
      fever may be beneficial in critically ill adults. Due to the physiological differences&#xD;
      between adults and children there is an important need to evaluate whether a different&#xD;
      approach to fever management in critically ill children may also be beneficial.&#xD;
&#xD;
      Prior to conducting a large, expensive, randomised clinical trial (RCT) to evaluate whether a&#xD;
      higher temperature threshold in starting treatments to cool down the child would be&#xD;
      beneficial, we are conducting three studies to know if it is possible for us to test key&#xD;
      outcome measures as a result of testing different temperatures thresholds for antipyretic&#xD;
      management.&#xD;
&#xD;
      The Fever Observational Study is one of these studies, with the aim of identifying: the&#xD;
      potential population that would be eligible for the proposed definitive trial, current&#xD;
      temperature threshold(s) for fever management, and to describe the characteristics of outcome&#xD;
      measures with the intention of deciding on a main measure to see which treatment method was&#xD;
      more successful.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Anticipated">February 2017</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>30 Days</target_duration>
  <primary_outcome>
    <measure>To determine the number of patients who meet the eligibility criteria for a proposed definitive trial.</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Temperature thresholds currently employed in at least 20 paediatric intensive care units (PICU) in the UK</measure>
    <time_frame>First 5 calender days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of ventilation - mean (standard deviation)</measure>
    <time_frame>Through study completion, an average of 2 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of PICU stay - mean (standard deviation)</measure>
    <time_frame>Through study completion, an average of 2 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PICU mortality - number (percentage)</measure>
    <time_frame>Through study completion, an average of 2 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital mortality - number (percentage)</measure>
    <time_frame>Through study completion, an average of 2 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Days of organ specific support - mean (standard deviation)</measure>
    <time_frame>Through study completion, an average of 2 days</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">3960</enrollment>
  <condition>Fever</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All unplanned admissions to a PICU&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        unplanned PICU admission referral requiring PICU admission to a participating unit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Peters, MBChB, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Child Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Intensive Care National Audit and Research Centre</name>
      <address>
        <city>London</city>
        <zip>WC1V 6AZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</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>Fever</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03028818
org study id: IRAS 209929
nct id: NCT03028818
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To inform the feasibility of conducting a study to test different temperature thresholds at
      which clinicians deliver interventions to reduce fever (i.e. antipyretic interventions) in
      critically ill children with fever due to infection.
Fever (high temperature) is a normal bodily response to an infection, which has shown to have
      a beneficial effect in humans with chickenpox, malaria and rhinovirus infections. In children
      it has been recommended by the National Institute for Health and Care Excellence not to cool
      down the child using drugs or physical methods such as a cooling mat, with the sole aim to
      reducing the child's temperature. However, this recommendation is not aimed at the management
      of critically ill children, to which there is uncertainty around use of cooling interventions
      when considering the advantages of a fever in defending the body against viruses and bacteria
      during critical illness, and weighing that up with the possible negative physiological
      consequences of a high fever e.g. increased metabolic rate.

      Observational studies show that the treatment of fever in critically ill children is
      inconsistent. There is a lack of robust data to guide antipyretic intervention, with
      clinicians usually starting fever management at around 37.5°C. Evidence is emerging that
      fever may be beneficial in critically ill adults. Due to the physiological differences
      between adults and children there is an important need to evaluate whether a different
      approach to fever management in critically ill children may also be beneficial.

      Prior to conducting a large, expensive, randomised clinical trial (RCT) to evaluate whether a
      higher temperature threshold in starting treatments to cool down the child would be
      beneficial, we are conducting three studies to know if it is possible for us to test key
      outcome measures as a result of testing different temperatures thresholds for antipyretic
      management.

      The Fever Observational Study is one of these studies, with the aim of identifying: the
      potential population that would be eligible for the proposed definitive trial, current
      temperature threshold(s) for fever management, and to describe the characteristics of outcome
      measures with the intention of deciding on a main measure to see which treatment method was
      more successful.
observational model: Cohort
time perspective: Prospective
measure: To determine the number of patients who meet the eligibility criteria for a proposed definitive trial.
time frame: Baseline
measure: Temperature thresholds currently employed in at least 20 paediatric intensive care units (PICU) in the UK
time frame: First 5 calender days
measure: Length of ventilation - mean (standard deviation)
time frame: Through study completion, an average of 2 days
measure: Length of PICU stay - mean (standard deviation)
time frame: Through study completion, an average of 2 days
measure: PICU mortality - number (percentage)
time frame: Through study completion, an average of 2 days
measure: Hospital mortality - number (percentage)
time frame: Through study completion, an average of 2 days
measure: Days of organ specific support - mean (standard deviation)
time frame: Through study completion, an average of 2 days
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 15 Years
healthy volunteers: No
last name: Mark Peters, MBChB, PhD
role: Principal Investigator
affiliation: Institute of Child Health
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Fever
sharing ipd: Undecided