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/NCT05966714</url>
    </required_header>
    <id_info>
      <org_study_id>20230509-z</org_study_id>
      <nct_id>NCT05966714</nct_id>
    </id_info>
    <brief_title>Neonatal Cerebral Oxygenation and Electrical Activity at Different Altitude Levels</brief_title>
    <official_title>Neonatal Cerebral Oxygenation and Electrical Activity at Different Altitude Levels: A Prospective Observational Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Children's Hospital of Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Children's Hospital of Fudan University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this study, the objective is to compare neonatal cerebral oxygenation and electrical&#xD;
        activity within 3 days after birth across different altitude areas using non-invasive&#xD;
        methods, specifically near infrared spectroscopy (NIRS) and amplitude-integrated&#xD;
        electroencephalography (aEEG), and establish reference value for each altitude level.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 30, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</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>
    <primary_outcome>
      <measure>Differences in cerebral oxygenation in neonates within three days after birth at different altitudes</measure>
      <time_frame>within three days after birth</time_frame>
      <description>Cerebral regional oxygen saturation (crSO2 in percentage) is measured by NIRS device.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Differences in tissue oxygen extraction in neonates within three days after birth at different altitudes</measure>
      <time_frame>within three days after birth</time_frame>
      <description>Tissue oxygen extraction (TOE in percentage) was calculated as TOE=SpO2- crSO2.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Differences in cerebral fractional tissue oxygen extraction in neonates within three days after birth at different altitudes</measure>
      <time_frame>within three days after birth</time_frame>
      <description>Cerebral fractional tissue oxygen extraction (cFTOE) is calculated as cFTOE = TOE/ SpO2.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Differences in aEEG indicators in neonates within three days after birth at different altitudes</measure>
      <time_frame>within three days after birth</time_frame>
      <description>aEEG data are acquired by aEEG device. This minimum and maximum value is used as the preliminary smoothing value for that specific time point. Next, a three-order low-pass filter is employed to further refine the preliminary values, and a phase compensation algorithm is applied to restore temporal information and obtain smoothed boundaries.The active sleep (AS) and quiet sleep (QS) cyclical pattern is recognized as periodic changes in the band-width of the aEEG tracing, with narrower and lower periods for AS and broader and higher periods for QS. For further analyzing the aEEG data, a total of 722 signal features were extracted to reflect the amplitude, rEEG, spectral density, and connectivity-related aspects by the Auto-Neo-EEG pipeline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Establish reference values for each altitude level</measure>
      <time_frame>within three days after birth</time_frame>
      <description>If significant differences exist across altitude levels, the 3rd, 10th, 50th, 75th, 90th, and 97th percentile for crSO2, upper and lower threshold of aEEG will be established for each group separately. Otherwise a combined reference interval will be provided using the average value of lower limit value.</description>
    </secondary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">170</enrollment>
    <condition>Altitude Hypoxia</condition>
    <condition>Neonatal Encephalopathy</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <description>Nujiang (880m)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <description>Kunming(1800m)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3</arm_group_label>
      <description>Lijiang(2500m)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 4</arm_group_label>
      <description>Shangri-La (3500 m)</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>NIRS</intervention_name>
      <description>cerebral oxygenation and electrical activity monitoring</description>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_label>Group 3</arm_group_label>
      <arm_group_label>Group 4</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>aEEG</intervention_name>
      <description>amplitude-integrated electroencephalography</description>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_label>Group 3</arm_group_label>
      <arm_group_label>Group 4</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy neonates at different altitude levels&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Singleton term infants (gestational age between 37 0/7 and 41 6/7 weeks) born in the&#xD;
               participating hospital.&#xD;
  &#xD;
            2. Infants appear well as defined by normal vital signs (heart rate ranging from 110 to&#xD;
               180 beats/min, respiratory rate ranging from 30 to 60 breaths/min, temperature ranging&#xD;
               from 36.5°C to 37.5°C), absence of signs of illness such as cyanosis, respiratory&#xD;
               distress and heart murmur.&#xD;
  &#xD;
            3. The mother is permanent residence of the current altitude level and live in the study&#xD;
               area for the entire duration of pregnancy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Need for supplemental oxygen or assisted ventilation.&#xD;
  &#xD;
            2. Any evidence of intrauterine distress such as meconium-stained amniotic fluid, Apgar&#xD;
               score &lt;7 at 1 or 5 min.&#xD;
  &#xD;
            3. Referred to neonatal intensive care unit or neonatology department for any reason&#xD;
               other than observation.&#xD;
  &#xD;
            4. With major congenital anomaly.&#xD;
  &#xD;
            5. Probes cannot be properly placed due to scalp lesions or hematomas.&#xD;
  &#xD;
            6. Reject or withdraw from the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Hours</minimum_age>
      <maximum_age>72 Hours</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Children Hospital of Fudan University</name>
        <address>
          <city>Shanghai</city>
          <zip>201102</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>altitude</keyword>
    <keyword>neonate</keyword>
    <keyword>Amplitude integrated electroencephalography</keyword>
    <keyword>cerebral oxygenation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Altitude Sickness</mesh_term>
      <mesh_term>Brain Diseases</mesh_term>
      <mesh_term>Hypoxia</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/NCT05966714
  org study id: 20230509-z
  nct id: NCT05966714
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  In this study, the objective is to compare neonatal cerebral oxygenation and electrical
        activity within 3 days after birth across different altitude areas using non-invasive
        methods, specifically near infrared spectroscopy (NIRS) and amplitude-integrated
        electroencephalography (aEEG), and establish reference value for each altitude level.
  observational model: Cohort
  time perspective: Prospective
  measure: Differences in cerebral oxygenation in neonates within three days after birth at different altitudes
  time frame: within three days after birth
  description: Cerebral regional oxygen saturation (crSO2 in percentage) is measured by NIRS device.
  measure: Differences in tissue oxygen extraction in neonates within three days after birth at different altitudes
  time frame: within three days after birth
  description: Tissue oxygen extraction (TOE in percentage) was calculated as TOE=SpO2- crSO2.
  measure: Differences in cerebral fractional tissue oxygen extraction in neonates within three days after birth at different altitudes
  time frame: within three days after birth
  description: Cerebral fractional tissue oxygen extraction (cFTOE) is calculated as cFTOE = TOE/ SpO2.
  measure: Differences in aEEG indicators in neonates within three days after birth at different altitudes
  time frame: within three days after birth
  description: aEEG data are acquired by aEEG device. This minimum and maximum value is used as the preliminary smoothing value for that specific time point. Next, a three-order low-pass filter is employed to further refine the preliminary values, and a phase compensation algorithm is applied to restore temporal information and obtain smoothed boundaries.The active sleep (AS) and quiet sleep (QS) cyclical pattern is recognized as periodic changes in the band-width of the aEEG tracing, with narrower and lower periods for AS and broader and higher periods for QS. For further analyzing the aEEG data, a total of 722 signal features were extracted to reflect the amplitude, rEEG, spectral density, and connectivity-related aspects by the Auto-Neo-EEG pipeline.
  measure: Establish reference values for each altitude level
  time frame: within three days after birth
  description: If significant differences exist across altitude levels, the 3rd, 10th, 50th, 75th, 90th, and 97th percentile for crSO2, upper and lower threshold of aEEG will be established for each group separately. Otherwise a combined reference interval will be provided using the average value of lower limit value.
  arm group label: Group 1
  description: Nujiang (880m)
  arm group label: Group 2
  description: Kunming(1800m)
  arm group label: Group 3
  description: Lijiang(2500m)
  arm group label: Group 4
  description: Shangri-La (3500 m)
  intervention type: Device
  intervention name: NIRS
  description: cerebral oxygenation and electrical activity monitoring
  arm group label: Group 1
  arm group label: Group 2
  arm group label: Group 3
  arm group label: Group 4
  intervention type: Device
  intervention name: aEEG
  description: amplitude-integrated electroencephalography
  arm group label: Group 1
  arm group label: Group 2
  arm group label: Group 3
  arm group label: Group 4
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 0 Hours
  maximum age: 72 Hours
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Altitude Sickness
  mesh term: Brain Diseases
  mesh term: Hypoxia
  sharing ipd: No