<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/NCT02996162</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00019957</org_study_id>
    <nct_id>NCT02996162</nct_id>
  </id_info>
  <brief_title>Hypercapnia and Its Association With Long-term Respiratory Morbidities in Premature Infants With Chronic Lung Disease</brief_title>
  <official_title>The Natural Course of Hypercapnia and Its Association With Long-term Respiratory Morbidities in Premature Infants With Chronic Lung Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, longitudinal observational study to provide data regarding the natural&#xD;
      course of hypercapnia in premature infants with bronchopulmonary dysplasia using both&#xD;
      available blood pCO2 and measured capnography, as well as relate the degree and trend of&#xD;
      hypercapnia to later respiratory outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data collection will begin once an infant no longer requires mechanical ventilation, CPAP,&#xD;
      and HFNC, up to twice per week while in the NICU. Investigators will obtain up to twenty&#xD;
      minutes of end-tidal capnography data, using Masimo ISA modules with continuous CO2 display.&#xD;
      Five minutes of good quality data, at approximately 30 breaths per minutes, should provide&#xD;
      approximately 150 data points. After filtering for artifact, the mean and range of end tidal&#xD;
      CO2 will be recorded during this interval. These recordings will be started after a feed for&#xD;
      infants receiving enteral feeds. The capnography cannula will be placed by the bedside nurse&#xD;
      or respiratory therapist at the conclusion of a feed and removed no later than the next feed.&#xD;
      If data is unable to be obtained, investigators will attempt to collect it at the next&#xD;
      regularly scheduled interval.&#xD;
&#xD;
      Available blood gases with pCO2 will also be recorded during the NICU hospitalization.&#xD;
&#xD;
      After discharge, consented subjects who are followed in the BCH outpatient pulmonary clinic&#xD;
      will have capnography recorded at every clinic visit for a period of up to twenty minutes,&#xD;
      and mean and range of end-tidal CO2 will be recorded after filtering for artifact. Available&#xD;
      blood gases with pCO2 during pulmonary visits will be recorded; blood gases during sick&#xD;
      encounters (i.e. emergency room) will be excluded. From available electronic medical record&#xD;
      (EMR) and clinic note data, investigators will also record duration of time on respiratory&#xD;
      support including positive pressure ventilation and nasal cannula oxygen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The research never began; the PI has chosen to no longer pursue this project.&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 1, 2020</start_date>
  <completion_date type="Actual">May 6, 2021</completion_date>
  <primary_completion_date type="Actual">May 6, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Respiratory symptoms and complications</measure>
    <time_frame>One year</time_frame>
    <description>Primary outcome will be respiratory symptoms at one year. Respiratory symptoms will be measured by a parent-reported respiratory symptom score obtained via questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Respiratory support</measure>
    <time_frame>One year</time_frame>
    <description>Secondary outcomes will include respiratory support, including duration of need for positive pressure ventilation (number of days), duration of need for supplemental oxygen (number of days), and use of respiratory related medications (yes or no response as to whether used and percentage of use).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory complications</measure>
    <time_frame>One year</time_frame>
    <description>Secondary outcome will be respiratory complications at one year. Complications will include death from respiratory cause (number of deaths), readmission for respiratory illness (number of readmissions), ICU admission (number of admissions), need for reintubation or positive pressure ventilation (number of events).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-respiratory complications</measure>
    <time_frame>One year</time_frame>
    <description>Secondary outcomes will include non-respiratory complications such as aspiration requiring limitation of oral feeding (percentage).</description>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Bronchopulmonary Dysplasia</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Massimo Root Monitoring System</intervention_name>
    <description>The Masimo Root system is a patient monitoring and connectivity platform; Root displays patient monitoring information from the connected modules. This will be used as a non-invasive way to determine infants' pCO2. The equipment will be used in the inpatient portion of the study up to twice weekly for 5 minutes to obtain approximately 150 end tidal CO2 values and recorded over time for each infant. In the outpatient portion, it will be used in each clinic visit in a similar fashion.</description>
    <other_name>Masimo Root Monitoring System and Accessories</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ISA-Infrared Sidestream Gas Analyzer</intervention_name>
    <description>The ISA-Infrared Sidestream Gas Analyzer displays end-tidal carbon dioxide waveforms and measurements and trends of end tidal CO2. This will be used as a non-invasive way to determine infants' pCO2. The equipment will be used in the inpatient portion of the study up to twice weekly for 5 minutes to obtain approximately 150 end tidal CO2 values and recorded over time for each infant. In the outpatient portion, it will be used in each clinic visit in a similar fashion.</description>
    <other_name>Infrared Sidestreamn gas Analyzer (ISA)</other_name>
    <other_name>Multigas Monitor</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Premature infants with chronic lung disease of prematurity or bronchopulmonary dysplasia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Potential eligible patients will be identified in the first 3-14 days of life at Beth&#xD;
             Israel Deaconess Hospital (BIDMC) NICU who have a birth gestational age &lt;=32 0/7 weeks&#xD;
             and current or previous requirement for positive pressure (ventilation or continuous&#xD;
             positive airway pressure (CPAP).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. death prior to discharge from the NICU,&#xD;
&#xD;
          2. chronic lung disease secondary to pulmonary conditions other than bronchopulmonary&#xD;
             dysplasia and&#xD;
&#xD;
          3. other underlying identified genetic syndromes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Days</minimum_age>
    <maximum_age>1 Year</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristen Leeman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>July 27, 2021</last_update_submitted>
  <last_update_submitted_qc>July 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Kristen Leeman</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Bronchopulmonary Dysplasia</keyword>
  <keyword>Chronic Lung Disease</keyword>
  <keyword>Prematurity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Bronchopulmonary Dysplasia</mesh_term>
    <mesh_term>Hypercapnia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02996162
org study id: IRB-P00019957
nct id: NCT02996162
lead sponsor: 
collaborator: 
has dmc: No
This is a prospective, longitudinal observational study to provide data regarding the natural
      course of hypercapnia in premature infants with bronchopulmonary dysplasia using both
      available blood pCO2 and measured capnography, as well as relate the degree and trend of
      hypercapnia to later respiratory outcomes.
Data collection will begin once an infant no longer requires mechanical ventilation, CPAP,
      and HFNC, up to twice per week while in the NICU. Investigators will obtain up to twenty
      minutes of end-tidal capnography data, using Masimo ISA modules with continuous CO2 display.
      Five minutes of good quality data, at approximately 30 breaths per minutes, should provide
      approximately 150 data points. After filtering for artifact, the mean and range of end tidal
      CO2 will be recorded during this interval. These recordings will be started after a feed for
      infants receiving enteral feeds. The capnography cannula will be placed by the bedside nurse
      or respiratory therapist at the conclusion of a feed and removed no later than the next feed.
      If data is unable to be obtained, investigators will attempt to collect it at the next
      regularly scheduled interval.

      Available blood gases with pCO2 will also be recorded during the NICU hospitalization.

      After discharge, consented subjects who are followed in the BCH outpatient pulmonary clinic
      will have capnography recorded at every clinic visit for a period of up to twenty minutes,
      and mean and range of end-tidal CO2 will be recorded after filtering for artifact. Available
      blood gases with pCO2 during pulmonary visits will be recorded; blood gases during sick
      encounters (i.e. emergency room) will be excluded. From available electronic medical record
      (EMR) and clinic note data, investigators will also record duration of time on respiratory
      support including positive pressure ventilation and nasal cannula oxygen.
observational model: Case-Only
time perspective: Prospective
measure: Respiratory symptoms and complications
time frame: One year
description: Primary outcome will be respiratory symptoms at one year. Respiratory symptoms will be measured by a parent-reported respiratory symptom score obtained via questionnaire.
measure: Respiratory support
time frame: One year
description: Secondary outcomes will include respiratory support, including duration of need for positive pressure ventilation (number of days), duration of need for supplemental oxygen (number of days), and use of respiratory related medications (yes or no response as to whether used and percentage of use).
measure: Respiratory complications
time frame: One year
description: Secondary outcome will be respiratory complications at one year. Complications will include death from respiratory cause (number of deaths), readmission for respiratory illness (number of readmissions), ICU admission (number of admissions), need for reintubation or positive pressure ventilation (number of events).
measure: Non-respiratory complications
time frame: One year
description: Secondary outcomes will include non-respiratory complications such as aspiration requiring limitation of oral feeding (percentage).
intervention type: Device
intervention name: Massimo Root Monitoring System
description: The Masimo Root system is a patient monitoring and connectivity platform; Root displays patient monitoring information from the connected modules. This will be used as a non-invasive way to determine infants' pCO2. The equipment will be used in the inpatient portion of the study up to twice weekly for 5 minutes to obtain approximately 150 end tidal CO2 values and recorded over time for each infant. In the outpatient portion, it will be used in each clinic visit in a similar fashion.
other name: Masimo Root Monitoring System and Accessories
intervention type: Device
intervention name: ISA-Infrared Sidestream Gas Analyzer
description: The ISA-Infrared Sidestream Gas Analyzer displays end-tidal carbon dioxide waveforms and measurements and trends of end tidal CO2. This will be used as a non-invasive way to determine infants' pCO2. The equipment will be used in the inpatient portion of the study up to twice weekly for 5 minutes to obtain approximately 150 end tidal CO2 values and recorded over time for each infant. In the outpatient portion, it will be used in each clinic visit in a similar fashion.
other name: Infrared Sidestreamn gas Analyzer (ISA)
other name: Multigas Monitor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Days
maximum age: 1 Year
healthy volunteers: No
last name: Kristen Leeman, MD
role: Principal Investigator
affiliation: Boston Children's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Kristen Leeman
investigator title: MD
mesh term: Lung Diseases
mesh term: Bronchopulmonary Dysplasia
mesh term: Hypercapnia
sharing ipd: No