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/NCT06016244</url>
    </required_header>
    <id_info>
      <org_study_id>2022.0100</org_study_id>
      <secondary_id>2023-504817-56</secondary_id>
      <nct_id>NCT06016244</nct_id>
    </id_info>
    <brief_title>Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial</brief_title>
    <acronym>OxyKids</acronym>
    <official_title>Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Spaarne Gasthuis</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Spaarne Gasthuis</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to find out at which lower limit for saturation (amount of&#xD;
        oxygen in the blood) we can best give extra oxygen to children that have been admitted for&#xD;
        shortness of breath. We hope to accomplish a shorter period of illness for these children and&#xD;
        that they can be discharged home earlier. Participants will receive supplemental oxygen if&#xD;
        their blood oxygen levels are below 88% or below 92%. After admission, (parents of)&#xD;
        participating children will fill out questionnaires. We will compare the two groups on their&#xD;
        hospitalization duration and recovery.&#xD;
  &#xD;
        In other words, is it better to maintain a lower limit of 88% saturation or a lower limit of&#xD;
        92% in children admitted for shortness of breath?&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Randomized controlled trial, parallel group, block randomized and stratified by age and centre.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Time to meeting all discharge criteria</measure>
      <time_frame>Discharge criteria are checked daily during admission up to discharge (generally a few days up to a week but longer if admission lasts longer) and the time and date at which all discharge criteria have been met will be recorded.</time_frame>
      <description>Time in hours from admission to meeting all discharge criteria</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Length of stay</measure>
      <time_frame>During admission</time_frame>
      <description>Time from admission to discharge in hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pediatric Intensive Care Unit (PICU) admissions</measure>
      <time_frame>During admission</time_frame>
      <description>Number of PICU admissions per group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time on oxygen therapy</measure>
      <time_frame>During admission</time_frame>
      <description>Time in hours spent on supplemental oxygen</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of symptoms</measure>
      <time_frame>from admission to 90 days after discharge</time_frame>
      <description>Measured as days from admission to having met all of the following criteria: resolution of cough, resolution of dyspnea as indicated by parent, cessation of scheduled bronchodilator use.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Return to normal health</measure>
      <time_frame>from admission to 90 days after discharge</time_frame>
      <description>Measured as days from admission to parent reported normal health. Upon discharge parents/patients are asked to record the last day of illness and report this in the follow-up questionnaires</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to return to school/daycare</measure>
      <time_frame>from admission to 90 days after discharge</time_frame>
      <description>Measured as days from admission to parent reported return to school/daycare</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Unscheduled health care visits or admissions after discharge</measure>
      <time_frame>from admission to 28 days after discharge</time_frame>
      <description>Number of unscheduled visits or admissions up to 28 days after discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient quality of life</measure>
      <time_frame>at discharge, 7, 28 and 90 days follow-up</time_frame>
      <description>Measured by digital questionnaire of EQ-5D-Y (modified versions are used in agreement with EuroQol for patients &lt; 4 years)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall pediatric health</measure>
      <time_frame>at discharge, 7, 28 and 90 days follow-up</time_frame>
      <description>ICHOM PROMIS Pediatric Global Health set</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parental anxiety</measure>
      <time_frame>at discharge, 7 and 28 days follow-up</time_frame>
      <description>by anxiety items of Hospital Anxiety and Depression Scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Economic evaluation</measure>
      <time_frame>Up to 90 days after discharge</time_frame>
      <description>The aim of the economic evaluation is to relate the incremental costs of an SpO2 of 88% (intervention) in comparison with an SpO2 of 92% (control) to the incremental health effects. Both a cost-effectiveness analysis (CEA) and a cost-utility analysis (CUA) will be performed from a societal and healthcare perspective</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Skin type influence</measure>
      <time_frame>Up to 90 days after discharge</time_frame>
      <description>Investigation in to the influence of skin type on safety and effectiveness outcomes</description>
    </other_outcome>
    <other_outcome>
      <measure>Time spent in 88%-92% window</measure>
      <time_frame>recorded at discharge based on monitoring data registered during admission, generally a few days to a week but longer if admission lasts longer.</time_frame>
      <description>Time spent in 88%-92% saturation window, measured by extracted continous monitoring data from patients where this is technically a possibility.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">560</enrollment>
    <condition>Bronchiolitis</condition>
    <condition>Lower Respiratory Tract Infection</condition>
    <condition>Bronchial Hyperreactivity</condition>
    <arm_group>
      <arm_group_label>88% oxygen saturation threshold</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in this arm will receive supplemental oxygen when SpO2 falls below 88% or when other clinical symptoms indicate a need for supplemental oxygen.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>92% oxygen saturation threshold</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients in this arm will receive supplemental oxygen when SpO2 falls below 92% or when other clinical symptoms indicate a need for supplemental oxygen.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Oxygen saturation threshold</intervention_name>
      <description>Oxygen saturation threshold on which supplemental oxygen is decided</description>
      <arm_group_label>88% oxygen saturation threshold</arm_group_label>
      <arm_group_label>92% oxygen saturation threshold</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  6 weeks to 12 years of age (corrected age for children with gestational age &lt; 37&#xD;
               weeks)&#xD;
  &#xD;
            -  hospitalized with respiratory distress due to bronchiolitis, viral wheeze or lower&#xD;
               respiratory tract infection, as diagnosed by the treating physician. Viral wheeze can&#xD;
               only be diagnosed below the age of 6 years.&#xD;
  &#xD;
            -  requiring supplemental oxygen as per usual care (SpO2 &lt;92% or for treating symptoms of&#xD;
               respiratory distress as determined by the treating physician&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  children with, except for the studied diseases, pre-existing cardiopulmonary,&#xD;
               neurological or hematological conditions (e.g. congenital thoracic malformation,&#xD;
               airway malacia, post infectious bronchiolitis obliterans, childhood interstitial lung&#xD;
               disease. primary immune deficiency)&#xD;
  &#xD;
            -  children born &lt;32 weeks gestational age&#xD;
  &#xD;
            -  children already included in other studies, which potentially interfere with this&#xD;
               study&#xD;
  &#xD;
            -  children (of parents) without a stable internet connection needed for answering&#xD;
               questionnaires&#xD;
  &#xD;
            -  children previously included in the current study&#xD;
  &#xD;
            -  considering questionnaires are only available in Dutch and English, children (of&#xD;
               parents) with different languages will be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Weeks</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Annmeie LM Boehmer, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Spaarne Gasthuis</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sam Louman, MD</last_name>
      <phone>+3123-2241645</phone>
      <email>slouman@spaarnegasthuis.nl</email>
    </overall_contact>
    <location>
      <facility>
        <name>Spaarne Gasthuis</name>
        <address>
          <city>Haarlem</city>
          <state>Noord-Holland</state>
          <zip>2035 RC</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <contact>
        <last_name>Annemie LM Boehmer, MD, PhD</last_name>
        <phone>+31232240070</phone>
        <email>aboehmer@spaarnegasthuis.nl</email>
      </contact>
      <contact_backup>
        <last_name>Sam Louman, MD</last_name>
        <phone>+31232241645</phone>
        <email>slouman@spaarnegasthuis.nl</email>
      </contact_backup>
      <investigator>
        <last_name>Annemie LM Boehmer, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Canisius Wilhelmina Ziekenhuis</name>
        <address>
          <city>Arnhem</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <contact>
        <last_name>Marianne L Brouwer</last_name>
        <phone>+31243658146</phone>
        <email>m.l.brouwer@cwz.nl</email>
      </contact>
      <investigator>
        <last_name>Marianne L Brouwer</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Rijnstate Ziekenhuis</name>
        <address>
          <city>Arnhem</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <contact>
        <last_name>Mirjam Scheffer</last_name>
        <phone>+31880057782</phone>
        <email>mscheffer@rijnstate.nl</email>
      </contact>
      <investigator>
        <last_name>Mirjam Scheffer</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Amphia Ziekenhuis</name>
        <address>
          <city>Breda</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <contact>
        <last_name>Anja Vaessen-Verberne</last_name>
        <phone>+31765951012</phone>
        <email>avaessen-verberne@amphia.nl</email>
      </contact>
      <investigator>
        <last_name>Anja Vaessen-Verberne</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Martini Ziekenhuis</name>
        <address>
          <city>Groningen</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <contact>
        <last_name>Arvid Kamps</last_name>
        <phone>+31505245245</phone>
        <email>akamps@martini.nl</email>
      </contact>
      <investigator>
        <last_name>Arvid Kamps</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tergooi Ziekenhuis</name>
        <address>
          <city>Hilversum</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <contact>
        <last_name>Caroline Kosterink-Brackel</last_name>
        <phone>+31887531160</phone>
        <email>ckosterinkbrackel@tergooi.nl</email>
      </contact>
      <investigator>
        <last_name>Caroline Kosterink-Brackel</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>St Antonius Ziekenhuis</name>
        <address>
          <city>Nieuwegein</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <contact>
        <last_name>Walter Balemans</last_name>
        <phone>+31883206300</phone>
        <email>w.balemans@antoniusziekenhuis.nl</email>
      </contact>
      <investigator>
        <last_name>Walter Balemans</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Franciscus Gasthuis en Vlietland</name>
        <address>
          <city>Rotterdam</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <contact>
        <last_name>Ismé de Kleer</last_name>
        <phone>+31104616225</phone>
        <email>i.kleer@franciscus.nl</email>
      </contact>
      <investigator>
        <last_name>Ismé de Kleer</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Isala Klinieken</name>
        <address>
          <city>Zwolle</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <contact>
        <last_name>Jolita Bekhof</last_name>
        <phone>+31886245050</phone>
        <email>j.bekhof@isala.nl</email>
      </contact>
      <investigator>
        <last_name>Jolita Bekhof</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Oxygen saturation target</keyword>
    <keyword>SpO2</keyword>
    <keyword>Children</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bronchiolitis</mesh_term>
      <mesh_term>Respiratory Tract Infections</mesh_term>
      <mesh_term>Bronchial Hyperreactivity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data and metadata will be made available for reuse after removing data from participants who did not consent to reuse of their data and removing any potentially identifiable data. Data archiving and sharing will be done through DANS EASY. The Dublin Core metadata scheme will be used.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>The data will only be made available for reuse after completion of the study and all planned publications of the results.</ipd_time_frame>
      <ipd_access_criteria>Other researchers will be able to find the metadata in the data repository. They could express their interest in the dataset through emailing the PI. After meeting the sharing and reuse conditions and approval of the PI, data access will be provided through the data repository.</ipd_access_criteria>
    </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/NCT06016244
  org study id: 2022.0100
  secondary id: 2023-504817-56
  nct id: NCT06016244
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to find out at which lower limit for saturation (amount of
        oxygen in the blood) we can best give extra oxygen to children that have been admitted for
        shortness of breath. We hope to accomplish a shorter period of illness for these children and
        that they can be discharged home earlier. Participants will receive supplemental oxygen if
        their blood oxygen levels are below 88% or below 92%. After admission, (parents of)
        participating children will fill out questionnaires. We will compare the two groups on their
        hospitalization duration and recovery.
  
        In other words, is it better to maintain a lower limit of 88% saturation or a lower limit of
        92% in children admitted for shortness of breath?
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized controlled trial, parallel group, block randomized and stratified by age and centre.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Time to meeting all discharge criteria
  time frame: Discharge criteria are checked daily during admission up to discharge (generally a few days up to a week but longer if admission lasts longer) and the time and date at which all discharge criteria have been met will be recorded.
  description: Time in hours from admission to meeting all discharge criteria
  measure: Length of stay
  time frame: During admission
  description: Time from admission to discharge in hours
  measure: Pediatric Intensive Care Unit (PICU) admissions
  time frame: During admission
  description: Number of PICU admissions per group
  measure: Time on oxygen therapy
  time frame: During admission
  description: Time in hours spent on supplemental oxygen
  measure: Duration of symptoms
  time frame: from admission to 90 days after discharge
  description: Measured as days from admission to having met all of the following criteria: resolution of cough, resolution of dyspnea as indicated by parent, cessation of scheduled bronchodilator use.
  measure: Return to normal health
  time frame: from admission to 90 days after discharge
  description: Measured as days from admission to parent reported normal health. Upon discharge parents/patients are asked to record the last day of illness and report this in the follow-up questionnaires
  measure: Time to return to school/daycare
  time frame: from admission to 90 days after discharge
  description: Measured as days from admission to parent reported return to school/daycare
  measure: Unscheduled health care visits or admissions after discharge
  time frame: from admission to 28 days after discharge
  description: Number of unscheduled visits or admissions up to 28 days after discharge
  measure: Patient quality of life
  time frame: at discharge, 7, 28 and 90 days follow-up
  description: Measured by digital questionnaire of EQ-5D-Y (modified versions are used in agreement with EuroQol for patients < 4 years)
  measure: Overall pediatric health
  time frame: at discharge, 7, 28 and 90 days follow-up
  description: ICHOM PROMIS Pediatric Global Health set
  measure: Parental anxiety
  time frame: at discharge, 7 and 28 days follow-up
  description: by anxiety items of Hospital Anxiety and Depression Scale
  measure: Economic evaluation
  time frame: Up to 90 days after discharge
  description: The aim of the economic evaluation is to relate the incremental costs of an SpO2 of 88% (intervention) in comparison with an SpO2 of 92% (control) to the incremental health effects. Both a cost-effectiveness analysis (CEA) and a cost-utility analysis (CUA) will be performed from a societal and healthcare perspective
  measure: Skin type influence
  time frame: Up to 90 days after discharge
  description: Investigation in to the influence of skin type on safety and effectiveness outcomes
  measure: Time spent in 88%-92% window
  time frame: recorded at discharge based on monitoring data registered during admission, generally a few days to a week but longer if admission lasts longer.
  description: Time spent in 88%-92% saturation window, measured by extracted continous monitoring data from patients where this is technically a possibility.
  arm group label: 88% oxygen saturation threshold
  arm group type: Experimental
  description: Patients in this arm will receive supplemental oxygen when SpO2 falls below 88% or when other clinical symptoms indicate a need for supplemental oxygen.
  arm group label: 92% oxygen saturation threshold
  arm group type: Active Comparator
  description: Patients in this arm will receive supplemental oxygen when SpO2 falls below 92% or when other clinical symptoms indicate a need for supplemental oxygen.
  intervention type: Other
  intervention name: Oxygen saturation threshold
  description: Oxygen saturation threshold on which supplemental oxygen is decided
  arm group label: 88% oxygen saturation threshold
  arm group label: 92% oxygen saturation threshold
  criteria: 
  gender: All
  minimum age: 6 Weeks
  maximum age: 12 Years
  healthy volunteers: No
  last name: Annmeie LM Boehmer, MD, PhD
  role: Principal Investigator
  affiliation: Spaarne Gasthuis
  last name: Sam Louman, MD
  phone: +3123-2241645
  email: slouman@spaarnegasthuis.nl
  facility: 
  contact: 
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  country: Netherlands
  responsible party type: Sponsor
  mesh term: Bronchiolitis
  mesh term: Respiratory Tract Infections
  mesh term: Bronchial Hyperreactivity
  sharing ipd: Yes
  ipd description: Data and metadata will be made available for reuse after removing data from participants who did not consent to reuse of their data and removing any potentially identifiable data. Data archiving and sharing will be done through DANS EASY. The Dublin Core metadata scheme will be used.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: The data will only be made available for reuse after completion of the study and all planned publications of the results.
  ipd access criteria: Other researchers will be able to find the metadata in the data repository. They could express their interest in the dataset through emailing the PI. After meeting the sharing and reuse conditions and approval of the PI, data access will be provided through the data repository.