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/NCT05965830</url>
    </required_header>
    <id_info>
      <org_study_id>P23-007</org_study_id>
      <nct_id>NCT05965830</nct_id>
    </id_info>
    <brief_title>the PROCEDURES Study</brief_title>
    <acronym>PROCEDURES</acronym>
    <official_title>PRospective Observational Study Comparing Electromyography of the Diaphragm With Ultrasound in Neonates and Children With REspiratory Support: the PROCEDURES Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Leiden University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Leiden University Medical Center</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>
        Background of the study:&#xD;
  &#xD;
        Increased work of breathing, potentially leading to respiratory insufficiency, resulting in&#xD;
        the need of (non-) invasive respiratory support is the most common observed problem in the&#xD;
        neonatal - and pediatric intensive care unit (NICU/PICU). The diaphragm is the main&#xD;
        respiratory muscle. Currently there is not an established technique accessible to observe the&#xD;
        (clinical) function of the diaphragm and its role in respiratory insufficiency. New&#xD;
        non-invasive modalities are promising, such as transcutaneous diaphragm electromyography&#xD;
        (dEMG) and diaphragm ultrasound (dUS).&#xD;
  &#xD;
        Objective of the study:&#xD;
  &#xD;
        Our objective is to assess the association between transcutaneous diaphragm electromyography&#xD;
        (dEMG) and diaphragm ultrasound (dUS) in the PICU population.&#xD;
  &#xD;
        Study design:&#xD;
  &#xD;
        Single center pilot study&#xD;
  &#xD;
        Study population:&#xD;
  &#xD;
        The study population consists of children between 0-12 months, admitted to the PICU of the&#xD;
        Leiden University Medical Center, with invasive respiratory support.&#xD;
  &#xD;
        Primary study parameters/outcome of the study:&#xD;
  &#xD;
        Primary endpoint is to evaluate the association between dEMG and dUS measurements in the PICU&#xD;
        population.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">October 2024</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>1 Day</target_duration>
    <primary_outcome>
      <measure>Primary endpoint</measure>
      <time_frame>1 year</time_frame>
      <description>to evaluate the association between dEMG and dUS measurements in the PICU population.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Ultrasound</condition>
    <condition>Transcutaneous EMG</condition>
    <condition>Diaphragm</condition>
    <condition>Neonate</condition>
    <arm_group>
      <arm_group_label>Study cohort</arm_group_label>
      <description>The study population consists of clinically stable infants or pediatric patients up to 12 months of age admitted to the PICU.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Diaphragm ultrasound</intervention_name>
      <description>A single, simultaneous assessment of the diaphragm muscle functioning through dEMG and dUS at the time of spontaneous breathing.</description>
      <arm_group_label>Study cohort</arm_group_label>
      <other_name>transcutaneous diaphragm EMG</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population consists of clinically stable infants or pediatric patients up to 12&#xD;
          months of age admitted to the PICU.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age between 0 - 12 months of age at the moment of inclusion and born ≥ 37 weeks&#xD;
               gestational age.&#xD;
  &#xD;
            -  Specific patients cohort PICU:&#xD;
  &#xD;
          pediatric patients with invasive respiratory support comply with the extubation readiness&#xD;
          test (ERT) criteria&#xD;
  &#xD;
            -  No spontaneous breathing for the duration of the assessment&#xD;
  &#xD;
            -  Written parenteral informed consent (IC)&#xD;
  &#xD;
            -  A patient can only participate once&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unilateral diaphragm paresis diagnosed by ultrasound&#xD;
  &#xD;
            -  Congenital malformations not compatible with dEMG&#xD;
  &#xD;
            -  Need of cardiac pacing&#xD;
  &#xD;
            -  Congenital muscle atrophy disorder&#xD;
  &#xD;
            -  Clinical instability requiring frequent interventions by the nursing staff that may&#xD;
               interfere with the measurements&#xD;
  &#xD;
            -  The attending physician considers the patient to be too vulnerable to participate in&#xD;
               the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Months</minimum_age>
      <maximum_age>12 Months</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Leiden University Medical Center</investigator_affiliation>
      <investigator_full_name>sgjheisterkamp</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05965830
  org study id: P23-007
  nct id: NCT05965830
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Background of the study:
  
        Increased work of breathing, potentially leading to respiratory insufficiency, resulting in
        the need of (non-) invasive respiratory support is the most common observed problem in the
        neonatal - and pediatric intensive care unit (NICU/PICU). The diaphragm is the main
        respiratory muscle. Currently there is not an established technique accessible to observe the
        (clinical) function of the diaphragm and its role in respiratory insufficiency. New
        non-invasive modalities are promising, such as transcutaneous diaphragm electromyography
        (dEMG) and diaphragm ultrasound (dUS).
  
        Objective of the study:
  
        Our objective is to assess the association between transcutaneous diaphragm electromyography
        (dEMG) and diaphragm ultrasound (dUS) in the PICU population.
  
        Study design:
  
        Single center pilot study
  
        Study population:
  
        The study population consists of children between 0-12 months, admitted to the PICU of the
        Leiden University Medical Center, with invasive respiratory support.
  
        Primary study parameters/outcome of the study:
  
        Primary endpoint is to evaluate the association between dEMG and dUS measurements in the PICU
        population.
  observational model: Cohort
  time perspective: Prospective
  measure: Primary endpoint
  time frame: 1 year
  description: to evaluate the association between dEMG and dUS measurements in the PICU population.
  arm group label: Study cohort
  description: The study population consists of clinically stable infants or pediatric patients up to 12 months of age admitted to the PICU.
  intervention type: Device
  intervention name: Diaphragm ultrasound
  description: A single, simultaneous assessment of the diaphragm muscle functioning through dEMG and dUS at the time of spontaneous breathing.
  arm group label: Study cohort
  other name: transcutaneous diaphragm EMG
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 0 Months
  maximum age: 12 Months
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Leiden University Medical Center
  investigator full name: sgjheisterkamp
  investigator title: MD
  sharing ipd: Undecided