xml: <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/NCT06037629</url>
    </required_header>
    <id_info>
      <org_study_id>299441</org_study_id>
      <nct_id>NCT06037629</nct_id>
    </id_info>
    <brief_title>Premature Enhanced Automated Capture of Comfort Knowledge</brief_title>
    <acronym>PEACOCK</acronym>
    <official_title>Premature Enhanced Automated Capture of Comfort Knowledge (PEACOCK)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Newcastle University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Newcastle-upon-Tyne Hospitals NHS Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Newcastle University</source>
    <oversight_info>
      <has_dmc>No</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>
        The goal of this observational study is to develop methods that could provide continual&#xD;
        monitoring of comfort levels for preterm neonates in hospitals.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        As preterm neonates have not developed ways to communicate how they are feeling like children&#xD;
        or adults do, clinicians must rely on their own understanding and professional judgements to&#xD;
        decide how comfortable they are. It is known that preterm neonates can display emotion&#xD;
        through ways such as facial expressions, body movements and changes in their physiology such&#xD;
        as heart rate. The investigators will record both behavioural (audiovisual) and physiologic&#xD;
        (heart rate, blood oxygen saturation) signals during routine clinical procedures ranging from&#xD;
        comforting, through discomforting to painful that are necessary as part of high-quality&#xD;
        medical care.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Pain Score Before Procedure</measure>
      <time_frame>1 minute recording before procedure</time_frame>
      <description>Score provided by nurses from Neonatal Pain, Agitation &amp; Sedation Scale. Pain/Agitation scores range from 0-13, higher scores indicate higher pain/agitation levels.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Audiovisual signal Before Procedure</measure>
      <time_frame>1 minute starting before procedure</time_frame>
      <description>Bedside recording using camera and microphone.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physiologic Signal Before Procedure: Heart Rate</measure>
      <time_frame>1 minute starting before procedure</time_frame>
      <description>Heart rate captured by bedside ECG monitor</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physiologic Signal Before Procedure: Blood Oxygen Saturation</measure>
      <time_frame>1 minute starting before procedure</time_frame>
      <description>Blood oxygen saturation captured by bedside oximetry monitor</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain Score During Procedure</measure>
      <time_frame>1 minute recording during procedure</time_frame>
      <description>Score provided by nurses from Neonatal Pain, Agitation &amp; Sedation Scale. Pain/Agitation scores range from 0-13, higher scores indicate higher pain/agitation levels.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Audiovisual Signal During Procedure</measure>
      <time_frame>1 minute during procedure</time_frame>
      <description>Bedside recording using camera and microphone</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physiologic Signal During Procedure: Heart Rate</measure>
      <time_frame>1 minute during procedure</time_frame>
      <description>Heart rate captured by bedside ECG monitor</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physiologic Signal During Procedure: Blood Oxygen Saturation</measure>
      <time_frame>1 minute during procedure</time_frame>
      <description>Blood oxygen saturation captured by bedside oximetry monitor</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain Score After Procedure</measure>
      <time_frame>1 minute recording immediately after procedure</time_frame>
      <description>Score provided by nurses from Neonatal Pain, Agitation &amp; Sedation Scale. Pain/Agitation scores range from 0-13, higher scores indicate higher pain/agitation levels.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Audiovisual Signal After Procedure</measure>
      <time_frame>1 minute immediately after procedure</time_frame>
      <description>Bedside recording using camera and microphone</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physiologic Signal After Procedure: Heart Rate</measure>
      <time_frame>1 minute immediately after procedure</time_frame>
      <description>Heart rate captured by bedside ECG monitor</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physiologic Signal After Procedure: Blood Oxygen Saturation</measure>
      <time_frame>1 minute immediately after procedure</time_frame>
      <description>Blood oxygen saturation captured by bedside oximetry monitor</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Acute Pain</condition>
    <condition>Pain, Procedural</condition>
    <condition>Agitation</condition>
    <condition>Discomfort</condition>
    <arm_group>
      <arm_group_label>Preterm neonates in intensive care</arm_group_label>
      <description>Preterm neonates born &lt;36 completed weeks of gestation with postmenstrual age &lt;36 weeks</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Preterm neonates hospitalised in the Royal Victoria Infirmary Neonatal Intensive Care Unit&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Preterm Infants born &lt;36 completed weeks of gestation&#xD;
  &#xD;
            -  Medically stable&#xD;
  &#xD;
            -  Written informed consent from parents&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Infants with significant brain, spine, or congenital abnormality&#xD;
  &#xD;
            -  Parents unwilling to provide consent&#xD;
  &#xD;
            -  Infants with postmenstrual age &gt;36 weeks&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>37 Weeks</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>The Newcastle Upon Tyne Hospitals Nhs Foundation Trust</name>
        <address>
          <city>Newcastle upon Tyne</city>
          <zip>NE1 4LP</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nicholas D Embleton</last_name>
        <phone>01912825156</phone>
        <email>nicholas.embleton@ncl.ac.uk</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>March 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Newcastle University</investigator_affiliation>
      <investigator_full_name>Arthur Howard</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Pain</mesh_term>
      <mesh_term>Pain, Procedural</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037629
  org study id: 299441
  nct id: NCT06037629
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to develop methods that could provide continual
        monitoring of comfort levels for preterm neonates in hospitals.
  As preterm neonates have not developed ways to communicate how they are feeling like children
        or adults do, clinicians must rely on their own understanding and professional judgements to
        decide how comfortable they are. It is known that preterm neonates can display emotion
        through ways such as facial expressions, body movements and changes in their physiology such
        as heart rate. The investigators will record both behavioural (audiovisual) and physiologic
        (heart rate, blood oxygen saturation) signals during routine clinical procedures ranging from
        comforting, through discomforting to painful that are necessary as part of high-quality
        medical care.
  observational model: Other
  time perspective: Prospective
  measure: Pain Score Before Procedure
  time frame: 1 minute recording before procedure
  description: Score provided by nurses from Neonatal Pain, Agitation & Sedation Scale. Pain/Agitation scores range from 0-13, higher scores indicate higher pain/agitation levels.
  measure: Audiovisual signal Before Procedure
  time frame: 1 minute starting before procedure
  description: Bedside recording using camera and microphone.
  measure: Physiologic Signal Before Procedure: Heart Rate
  time frame: 1 minute starting before procedure
  description: Heart rate captured by bedside ECG monitor
  measure: Physiologic Signal Before Procedure: Blood Oxygen Saturation
  time frame: 1 minute starting before procedure
  description: Blood oxygen saturation captured by bedside oximetry monitor
  measure: Pain Score During Procedure
  time frame: 1 minute recording during procedure
  description: Score provided by nurses from Neonatal Pain, Agitation & Sedation Scale. Pain/Agitation scores range from 0-13, higher scores indicate higher pain/agitation levels.
  measure: Audiovisual Signal During Procedure
  time frame: 1 minute during procedure
  description: Bedside recording using camera and microphone
  measure: Physiologic Signal During Procedure: Heart Rate
  time frame: 1 minute during procedure
  description: Heart rate captured by bedside ECG monitor
  measure: Physiologic Signal During Procedure: Blood Oxygen Saturation
  time frame: 1 minute during procedure
  description: Blood oxygen saturation captured by bedside oximetry monitor
  measure: Pain Score After Procedure
  time frame: 1 minute recording immediately after procedure
  description: Score provided by nurses from Neonatal Pain, Agitation & Sedation Scale. Pain/Agitation scores range from 0-13, higher scores indicate higher pain/agitation levels.
  measure: Audiovisual Signal After Procedure
  time frame: 1 minute immediately after procedure
  description: Bedside recording using camera and microphone
  measure: Physiologic Signal After Procedure: Heart Rate
  time frame: 1 minute immediately after procedure
  description: Heart rate captured by bedside ECG monitor
  measure: Physiologic Signal After Procedure: Blood Oxygen Saturation
  time frame: 1 minute immediately after procedure
  description: Blood oxygen saturation captured by bedside oximetry monitor
  arm group label: Preterm neonates in intensive care
  description: Preterm neonates born <36 completed weeks of gestation with postmenstrual age <36 weeks
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 37 Weeks
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: United Kingdom
  responsible party type: Principal Investigator
  investigator affiliation: Newcastle University
  investigator full name: Arthur Howard
  investigator title: Principal Investigator
  mesh term: Acute Pain
  mesh term: Pain, Procedural
  sharing ipd: No