<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/NCT01662544</url>
  </required_header>
  <id_info>
    <org_study_id>1103-041</org_study_id>
    <nct_id>NCT01662544</nct_id>
  </id_info>
  <brief_title>Heated High Flow Oxygen Use in Infants With Bronchiolitis and Hypoxia</brief_title>
  <acronym>HHFNC</acronym>
  <official_title>Comparison of Heated Humidified High-flow Nasal Cannula (HHFNC) Versus Standard Nasal Cannula Oxygen Delivery on Respiratory Distress and Length of Stay in Infants With Bronchiolitis and Hypoxia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospitals and Clinics of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospitals and Clinics of Minnesota</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bronchiolitis is a common cold weather seasonal respiratory illness affecting infants and&#xD;
      children. Multiple supportive therapies have been tried in infants with bronchiolitis&#xD;
      including albuterol, racemic epinephrine, hypertonic saline nebulization, but to date&#xD;
      supportive therapy with oxygen is the only proven therapy to decrease respiratory distress in&#xD;
      infants with bronchiolitis, with hypertonic saline showing a borderline statistically&#xD;
      significant improvement. This prospective, randomized study will compare CSS and PEWS scores&#xD;
      on infants who receive oxygen by standard flow nasal cannula and to those who receive oxygen&#xD;
      via Humidified High-Flow Nasal Cannula (HHFNC). The results will help determine if infants&#xD;
      with viral bronchiolitis who receive humidified high flow nasal cannula oxygen therapy have&#xD;
      improved Clinical Severity Score (CSS) and Pediatric Early Warning System (PEWS) scores and&#xD;
      ultimately decreased lengths of admissions when compared to patients treated with nasal&#xD;
      cannula oxygen therapy with/without bronchodilator therapy.&#xD;
&#xD;
      Hypothesis Heated Humidified High-flow Nasal Cannula Delivery of Oxygen decreases respiratory&#xD;
      distress as measured by pediatric CSS and PEWS when compared with routine nasal cannula&#xD;
      oxygen delivery in infants with bronchiolitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Actual">May 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CSS Scores</measure>
    <time_frame>Study specific</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>PEWS Score</measure>
    <time_frame>Study specific</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Oxygen needs</measure>
    <time_frame>Study specific</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Bronchiolitis</condition>
  <condition>Hypoxia</condition>
  <arm_group>
    <arm_group_label>HHFNC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Heated High Flow arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Nasal Cannula</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Oxygen delivery</intervention_name>
    <arm_group_label>HHFNC</arm_group_label>
    <arm_group_label>Standard Nasal Cannula</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Are previously healthy infants ages 3 months to 18 months of age&#xD;
&#xD;
          2. Have O2 saturations of &lt; 92% on room air while awake&#xD;
&#xD;
          3. Have a clinical diagnosis of bronchiolitis&#xD;
&#xD;
          4. Have a CSS score showing moderate distress &gt;4&#xD;
&#xD;
          5. Have a planned admission to the hospital for either inpatient or observation status&#xD;
&#xD;
          6. Have parental consent to enroll in study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have significant apnea or bradycardia events reported by parent or witnessed in&#xD;
             Emergency Department&#xD;
&#xD;
          2. Have prior airway disease diagnosis other than URI within the previous two months&#xD;
&#xD;
          3. Were previously intubated; previously having had airway bronchoscopy or surgery&#xD;
&#xD;
          4. They are ex-preemies, i.e. had an estimated gestational age of &lt;37 weeks at time of&#xD;
             birth&#xD;
&#xD;
          5. Have a diagnosis of lobar consolidation or round pneumonia by Chest x-ray&#xD;
&#xD;
          6. Have pleural disease by chest x-ray&#xD;
&#xD;
          7. Have history of cardiac disease, renal disease, hematologic disease such as sickle&#xD;
             cell disease or leukemia, congenital hemoglobinopathies or Congenital Adrenal&#xD;
             Hyperplasia&#xD;
&#xD;
          8. Have undergone prior radiation or chemotherapy&#xD;
&#xD;
          9. Have functional or anatomical bowel obstruction as demonstrated by persistent vomiting&#xD;
             or tensely distended abdomen&#xD;
&#xD;
         10. Have history of Choanal atresia or cleft palate&#xD;
&#xD;
         11. Have history of neuromuscular disorder, e.g., Spinal muscular atrophy, muscular&#xD;
             dystrophies, cerebral palsy or hypotonia&#xD;
&#xD;
         12. Have impending respiratory failure as demonstrated by blood gas with pCO2 of greater&#xD;
             than 60 or apnea spells lasting greater than 30 seconds&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>18 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donna Milner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospitals and Clinics of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospitals and Clinics of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>July 18, 2017</last_update_submitted>
  <last_update_submitted_qc>July 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infants</keyword>
  <keyword>Bronchiolitis</keyword>
  <keyword>Hypoxia</keyword>
  <keyword>Emergency Department</keyword>
  <keyword>Length of Stay</keyword>
  <keyword>Pediatrics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <!-- 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/NCT01662544
org study id: 1103-041
nct id: NCT01662544
lead sponsor: 
has dmc: Yes
Bronchiolitis is a common cold weather seasonal respiratory illness affecting infants and
      children. Multiple supportive therapies have been tried in infants with bronchiolitis
      including albuterol, racemic epinephrine, hypertonic saline nebulization, but to date
      supportive therapy with oxygen is the only proven therapy to decrease respiratory distress in
      infants with bronchiolitis, with hypertonic saline showing a borderline statistically
      significant improvement. This prospective, randomized study will compare CSS and PEWS scores
      on infants who receive oxygen by standard flow nasal cannula and to those who receive oxygen
      via Humidified High-Flow Nasal Cannula (HHFNC). The results will help determine if infants
      with viral bronchiolitis who receive humidified high flow nasal cannula oxygen therapy have
      improved Clinical Severity Score (CSS) and Pediatric Early Warning System (PEWS) scores and
      ultimately decreased lengths of admissions when compared to patients treated with nasal
      cannula oxygen therapy with/without bronchodilator therapy.

      Hypothesis Heated Humidified High-flow Nasal Cannula Delivery of Oxygen decreases respiratory
      distress as measured by pediatric CSS and PEWS when compared with routine nasal cannula
      oxygen delivery in infants with bronchiolitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: CSS Scores
time frame: Study specific
measure: PEWS Score
time frame: Study specific
measure: Oxygen needs
time frame: Study specific
arm group label: HHFNC
arm group type: Experimental
description: Heated High Flow arm
arm group label: Standard Nasal Cannula
arm group type: Active Comparator
description: Standard treatment
intervention type: Procedure
intervention name: Oxygen delivery
arm group label: HHFNC
arm group label: Standard Nasal Cannula
criteria: 
gender: All
minimum age: 3 Months
maximum age: 18 Months
healthy volunteers: No
last name: Donna Milner, MD
role: Principal Investigator
affiliation: Children's Hospitals and Clinics of Minnesota
facility: 
country: United States
responsible party type: Sponsor
mesh term: Bronchiolitis
mesh term: Hypoxia