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/NCT05994183</url>
    </required_header>
    <id_info>
      <org_study_id>275605</org_study_id>
      <nct_id>NCT05994183</nct_id>
    </id_info>
    <brief_title>The Bronchiolitis in Hospitalized Infants Study</brief_title>
    <acronym>BroncHI</acronym>
    <official_title>The Bronchiolitis in Hospitalized Infants (BroncHI) Study: A Feasibility Trial Aimed to Identify and Treat Hospitalized Infants With Bronchiolitis Most at Risk for Recurrent Wheezing and Asthma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>IDeA States Pediatric Clinical Trials Network</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institutes of Health (NIH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Nebraska</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>IDeA States Pediatric Clinical Trials Network</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</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 determine whether it is possible to identify, enroll,&#xD;
        and deliver the study intervention (the corticosteroid dexamethasone) in hospitalized infants&#xD;
        with bronchiolitis.&#xD;
  &#xD;
        Participants in this study will be given two doses of dexamethasone within 72 hours of&#xD;
        enrollment, followed by 30 days of safety monitoring.&#xD;
  &#xD;
        Results of this feasibility pilot study may be used to inform the design of a future&#xD;
        randomized controlled trial, whose results in turn could induce a paradigm shift in acute&#xD;
        management of bronchiolitis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a open-label single-arm pilot study to assess feasibility of study procedures. The&#xD;
        study population is infants &lt;24 months of age, admitted with a physician diagnosis of non-RSV&#xD;
        bronchiolitis that meet at least one of the following criteria: 1) history of breathing&#xD;
        problems, 2) history of eczema, and/or 3) family history of asthma.&#xD;
  &#xD;
        The primary objective is to assess the ability to administer 2 doses of dexamethasone to&#xD;
        infants hospitalized with bronchiolitis meeting the inclusion criteria. The literature&#xD;
        suggests that prompt intervention in the course of bronchiolitis disease is important for&#xD;
        possibly altering the immune response and sequelae. Therefore, it is important that we are&#xD;
        able to demonstrate the ability to initiate the intervention while the child is still&#xD;
        hospitalized and complete the number of doses with the desired anti-inflammatory effect. We&#xD;
        aim to successfully administer both doses of the study medication in 87% of infants enrolled.&#xD;
  &#xD;
        Enrolling sites will recruit participants in collaboration with outpatient practices within&#xD;
        Environmental influences on Child Health Outcomes (ECHO) Institutional Development Award&#xD;
        (IDeA) States Pediatric Clinical Trials Network (ISPCTN) states that provide primary care&#xD;
        services to children (&lt;24 months old). Sites will serve a population base of at least 40%&#xD;
        Medicaid/uninsured children, &lt;60% non-Hispanic White children, or &gt;40% of families residing&#xD;
        in rural communities.&#xD;
  &#xD;
        Participants will be enrolled on the study for approximately 30 days. While in the study they&#xD;
        will receive dexamethasone at a dose of 0.6 mg/kg/dose orally (max 16 mg/dose) per day for 2&#xD;
        days. The 1st dose will be given while the infant is inpatient (within 24 hours following&#xD;
        enrollment). The 2nd dose will be given on Day 2, either inpatient or at home. The time&#xD;
        interval between doses will be between 12 and 48 hours. Participants will be followed for&#xD;
        safety information 30 days (±4 days) after the 2nd dose.&#xD;
  &#xD;
        The study duration is 24 months (2 months start-up, 17 months enrollment, 1 month follow-up,&#xD;
        and 3 months close-out and data analysis).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Withdrawn</overall_status>
    <why_stopped>
      The study was withdrawn with no participants enrolled due to the need for an IND from the FDA,&#xD;
      which significantly expanded the scope of the study beyond what was originally anticipated for&#xD;
      a pilot project within this network.&#xD;
    </why_stopped>
    <start_date type="Anticipated">October 9, 2023</start_date>
    <completion_date type="Anticipated">April 14, 2025</completion_date>
    <primary_completion_date type="Anticipated">March 9, 2025</primary_completion_date>
    <phase>Early Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>An open-label single-arm pilot study to assess feasibility of study procedures.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants that receive 2 doses of dexamethasone per protocol.</measure>
      <time_frame>Intervention: 72 hours; Follow-up: 30 days</time_frame>
      <description>A total of N=30 recruited participants will be enrolled into the study. In the primary objective, we expect 26 out of 30 (87%) participating infants will successfully receive 2 doses of dexamethasone per protocol.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">0</enrollment>
    <condition>Bronchiolitis</condition>
    <arm_group>
      <arm_group_label>Dexamethasone Administration</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dexamethasone will be given orally to all consented participants. Two doses will be administered within 12-48 hours, with at least the 1st dose administered during the bronchiolitis hospitalization. If the participant is discharged before the 2nd dose, it will be administered at home.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexamethasone Oral</intervention_name>
      <description>Dexamethasone 0.6 mg/kg/dose orally (max 16 mg/dose)</description>
      <arm_group_label>Dexamethasone Administration</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Infants &lt;24 months of age at time of enrollment&#xD;
  &#xD;
            -  Admitted to the hospitalist service with a diagnosis of bronchiolitis&#xD;
  &#xD;
            -  RSV and COVID-19 Negative&#xD;
  &#xD;
            -  At least one of the following clinical criteria:&#xD;
  &#xD;
                 -  personal history of breathing problems&#xD;
  &#xD;
                 -  personal history of eczema&#xD;
  &#xD;
                 -  parental history of asthma&#xD;
  &#xD;
            -  Parental ability to speak and read English or Spanish&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Preterm Infant (born at &lt; 34 weeks' gestation)&#xD;
  &#xD;
            -  Diagnosis of asthma&#xD;
  &#xD;
            -  Known underlying heart failure, hypertension, gastrointestinal bleeding, liver&#xD;
               disease, thyroid disease (per parental report and chart review)&#xD;
  &#xD;
            -  Currently taking corticosteroids (inhaled or oral) or have taken corticosteroids&#xD;
               within 7 days prior to hospitalization (per parental report and chart review)&#xD;
  &#xD;
            -  Admission to the intensive care unit (ICU) at time of enrollment&#xD;
  &#xD;
            -  Participants (caregivers) who, in the view of the investigator, whom are unlikely able&#xD;
               to comply with the protocol requirements&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Months</minimum_age>
      <maximum_age>24 Months</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kari Neemann, MD</last_name>
      <role>Study Chair</role>
      <affiliation>University of Nebraska</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ashley Deschamp, MD,MS</last_name>
      <role>Study Chair</role>
      <affiliation>University of Nebraska</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Arkansas Children's Hospital</name>
        <address>
          <city>Little Rock</city>
          <state>Arkansas</state>
          <zip>72202</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>University of Nebraska Medical Center</name>
        <address>
          <city>Omaha</city>
          <state>Nebraska</state>
          <zip>68198</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Infants &lt;24 months of age hospitalized with bronchiolitis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bronchiolitis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexamethasone</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The study team will place participant's de-identified data and other limited information, such as race and ethnic group, into one or more centralized database(s). The study team will share this data in compliance with the ISPCTN and NIH data sharing policies.</ipd_description>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>NIH Public Access Policy ensures public access to the published results of NIH-funded research. Scientists are required to submit final peer-reviewed journal manuscripts from NIH funds to the digital archive PubMed Central upon publication acceptance.&#xD;
  ECHO ISPCTN Publications and Presentations Policy, ensures accurate, responsible, and efficient communication of findings from ECHO ISPCTN clinical trials. The ECHO ISPCTN Steering Committee has approved and ratified the Publications and Presentations Policy, which includes representatives from all site awardees, as well as representatives from NIH and the DCOC NIH Data Sharing Policy, the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission Rule. Trial results will be submitted to ClinicalTrials.gov. Additional plans are to publish results in peer reviewed journals. Researchers may request trial data by contacting Jeannette Lee, PhD, at the DCOC.</ipd_time_frame>
      <ipd_access_criteria>TBA</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/NCT05994183
  org study id: 275605
  nct id: NCT05994183
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to determine whether it is possible to identify, enroll,
        and deliver the study intervention (the corticosteroid dexamethasone) in hospitalized infants
        with bronchiolitis.
  
        Participants in this study will be given two doses of dexamethasone within 72 hours of
        enrollment, followed by 30 days of safety monitoring.
  
        Results of this feasibility pilot study may be used to inform the design of a future
        randomized controlled trial, whose results in turn could induce a paradigm shift in acute
        management of bronchiolitis.
  This is a open-label single-arm pilot study to assess feasibility of study procedures. The
        study population is infants <24 months of age, admitted with a physician diagnosis of non-RSV
        bronchiolitis that meet at least one of the following criteria: 1) history of breathing
        problems, 2) history of eczema, and/or 3) family history of asthma.
  
        The primary objective is to assess the ability to administer 2 doses of dexamethasone to
        infants hospitalized with bronchiolitis meeting the inclusion criteria. The literature
        suggests that prompt intervention in the course of bronchiolitis disease is important for
        possibly altering the immune response and sequelae. Therefore, it is important that we are
        able to demonstrate the ability to initiate the intervention while the child is still
        hospitalized and complete the number of doses with the desired anti-inflammatory effect. We
        aim to successfully administer both doses of the study medication in 87% of infants enrolled.
  
        Enrolling sites will recruit participants in collaboration with outpatient practices within
        Environmental influences on Child Health Outcomes (ECHO) Institutional Development Award
        (IDeA) States Pediatric Clinical Trials Network (ISPCTN) states that provide primary care
        services to children (<24 months old). Sites will serve a population base of at least 40%
        Medicaid/uninsured children, <60% non-Hispanic White children, or >40% of families residing
        in rural communities.
  
        Participants will be enrolled on the study for approximately 30 days. While in the study they
        will receive dexamethasone at a dose of 0.6 mg/kg/dose orally (max 16 mg/dose) per day for 2
        days. The 1st dose will be given while the infant is inpatient (within 24 hours following
        enrollment). The 2nd dose will be given on Day 2, either inpatient or at home. The time
        interval between doses will be between 12 and 48 hours. Participants will be followed for
        safety information 30 days (±4 days) after the 2nd dose.
  
        The study duration is 24 months (2 months start-up, 17 months enrollment, 1 month follow-up,
        and 3 months close-out and data analysis).
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: An open-label single-arm pilot study to assess feasibility of study procedures.
  primary purpose: Other
  masking: None (Open Label)
  measure: Number of participants that receive 2 doses of dexamethasone per protocol.
  time frame: Intervention: 72 hours; Follow-up: 30 days
  description: A total of N=30 recruited participants will be enrolled into the study. In the primary objective, we expect 26 out of 30 (87%) participating infants will successfully receive 2 doses of dexamethasone per protocol.
  arm group label: Dexamethasone Administration
  arm group type: Experimental
  description: Dexamethasone will be given orally to all consented participants. Two doses will be administered within 12-48 hours, with at least the 1st dose administered during the bronchiolitis hospitalization. If the participant is discharged before the 2nd dose, it will be administered at home.
  intervention type: Drug
  intervention name: Dexamethasone Oral
  description: Dexamethasone 0.6 mg/kg/dose orally (max 16 mg/dose)
  arm group label: Dexamethasone Administration
  criteria: 
  gender: All
  minimum age: 0 Months
  maximum age: 24 Months
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kari Neemann, MD
  role: Study Chair
  affiliation: University of Nebraska
  last name: Ashley Deschamp, MD,MS
  role: Study Chair
  affiliation: University of Nebraska
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Bronchiolitis
  mesh term: Dexamethasone
  sharing ipd: Yes
  ipd description: The study team will place participant's de-identified data and other limited information, such as race and ethnic group, into one or more centralized database(s). The study team will share this data in compliance with the ISPCTN and NIH data sharing policies.
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: NIH Public Access Policy ensures public access to the published results of NIH-funded research. Scientists are required to submit final peer-reviewed journal manuscripts from NIH funds to the digital archive PubMed Central upon publication acceptance.
  ECHO ISPCTN Publications and Presentations Policy, ensures accurate, responsible, and efficient communication of findings from ECHO ISPCTN clinical trials. The ECHO ISPCTN Steering Committee has approved and ratified the Publications and Presentations Policy, which includes representatives from all site awardees, as well as representatives from NIH and the DCOC NIH Data Sharing Policy, the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission Rule. Trial results will be submitted to ClinicalTrials.gov. Additional plans are to publish results in peer reviewed journals. Researchers may request trial data by contacting Jeannette Lee, PhD, at the DCOC.
  ipd access criteria: TBA