<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/NCT03288857</url>
  </required_header>
  <id_info>
    <org_study_id>2017-06-0086</org_study_id>
    <nct_id>NCT03288857</nct_id>
  </id_info>
  <brief_title>Comparison of the Bulb Aspirator to a Nasal Oral Aspirator in the Treatment of Bronchiolitis</brief_title>
  <official_title>Comparison of the Bulb Aspirator to a Nasal Oral Aspirator in the Treatment of Bronchiolitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas at Austin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dell Children's Medical Center of Central Texas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas at Austin</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>
      The investigators aim to compare the standard bulb aspirator with that of a nasal oral&#xD;
      aspirator. The hypothesis is that use of a nasal oral aspirator is more effective at removing&#xD;
      nasal secretions in the treatment of bronchiolitis as measured by a predicted 50% decrease in&#xD;
      the rate of unscheduled bronchiolitis return visits. The primary endpoint will be the number&#xD;
      of unscheduled bronchiolitis return visits; secondary endpoints will include measurements of&#xD;
      oral intake, respiratory relief, parental device preference and adverse events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a single center, single blind, randomized controlled trial in the&#xD;
      pediatric emergency department (ED) at Dell Children's Medical Center of Central Texas&#xD;
      (DCMC). An ED discharge diagnosis of bronchiolitis will trigger patients to be randomized to&#xD;
      receive a bulb aspirator or nasal oral aspirator for home secretion management use. Prior to&#xD;
      dispensing the randomized aspirator, a pre-distribution questionnaire will be administered.&#xD;
      Additionally, patients will receive a diary to complete for 3 days post ED discharge.&#xD;
      Research personnel will call families on day 4 as a reminder to return the diary and again on&#xD;
      day 14 to obtain a verbal post-study questionnaire. Research personnel will perform chart&#xD;
      review on all patients looking for unscheduled patient return visits for bronchiolitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 22, 2017</start_date>
  <completion_date type="Actual">March 21, 2019</completion_date>
  <primary_completion_date type="Actual">March 21, 2019</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Unscheduled bronchiolitis return visits</measure>
    <time_frame>14 days</time_frame>
    <description>The number of unscheduled bronchiolitis return visits (return to either ED, urgent care or PCP)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oral intake</measure>
    <time_frame>14 days</time_frame>
    <description>Effects of device on oral intake as determined by diary and post-study questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory relief</measure>
    <time_frame>14 days</time_frame>
    <description>Effects of device on respiratory relief as determined by diary and post-study questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental device preference</measure>
    <time_frame>14 days</time_frame>
    <description>Parental device preference as determined by diary and post-study questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>14 days</time_frame>
    <description>Description of adverse events as determined by diary and post-study questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">236</enrollment>
  <condition>Bronchiolitis</condition>
  <condition>Aspirator</condition>
  <arm_group>
    <arm_group_label>Bulb Aspirator</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>If randomized to the bulb aspirator group, the patient will be sent home with a bulb aspirator to use for home nasal secretion management</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nasal Oral Aspirator (NeilMed Naspira)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If randomized to the nasal oral aspirator group, patient will be sent home with a nasal oral aspirator to use for home nasal secretion management</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NeilMed Naspira</intervention_name>
    <description>NeilMed Naspira is a nasal-oral aspirator</description>
    <arm_group_label>Nasal Oral Aspirator (NeilMed Naspira)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children &gt;28 days of life to &lt; 2 years of age discharged home from the DCMC ED with a&#xD;
             diagnosis of bronchiolitis (diagnosis made per provider discretion)&#xD;
&#xD;
          -  Caregiver fluent in English or Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous enrollment&#xD;
&#xD;
          -  Hospital admission&#xD;
&#xD;
          -  Parental refusal to be randomized to an aspirator device (i.e., family prefers current&#xD;
             device and does not wish to be randomized to a potentially different product)&#xD;
&#xD;
          -  Current bacterial pneumonia&#xD;
&#xD;
          -  Diagnosis of asthma&#xD;
&#xD;
          -  Chronic lung disease&#xD;
&#xD;
          -  Significant underlying cardiac disease&#xD;
&#xD;
          -  Chronic neuromuscular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dell Children's Medical Center of Central Texas</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>April 18, 2019</last_update_submitted>
  <last_update_submitted_qc>April 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas at Austin</investigator_affiliation>
    <investigator_full_name>Whitney Schwarz</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Naspira</keyword>
  <keyword>Suctioning</keyword>
  <keyword>Nasal suction device</keyword>
  <keyword>Children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03288857
org study id: 2017-06-0086
nct id: NCT03288857
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators aim to compare the standard bulb aspirator with that of a nasal oral
      aspirator. The hypothesis is that use of a nasal oral aspirator is more effective at removing
      nasal secretions in the treatment of bronchiolitis as measured by a predicted 50% decrease in
      the rate of unscheduled bronchiolitis return visits. The primary endpoint will be the number
      of unscheduled bronchiolitis return visits; secondary endpoints will include measurements of
      oral intake, respiratory relief, parental device preference and adverse events.
This study will be a single center, single blind, randomized controlled trial in the
      pediatric emergency department (ED) at Dell Children's Medical Center of Central Texas
      (DCMC). An ED discharge diagnosis of bronchiolitis will trigger patients to be randomized to
      receive a bulb aspirator or nasal oral aspirator for home secretion management use. Prior to
      dispensing the randomized aspirator, a pre-distribution questionnaire will be administered.
      Additionally, patients will receive a diary to complete for 3 days post ED discharge.
      Research personnel will call families on day 4 as a reminder to return the diary and again on
      day 14 to obtain a verbal post-study questionnaire. Research personnel will perform chart
      review on all patients looking for unscheduled patient return visits for bronchiolitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Unscheduled bronchiolitis return visits
time frame: 14 days
description: The number of unscheduled bronchiolitis return visits (return to either ED, urgent care or PCP)
measure: Oral intake
time frame: 14 days
description: Effects of device on oral intake as determined by diary and post-study questionnaire
measure: Respiratory relief
time frame: 14 days
description: Effects of device on respiratory relief as determined by diary and post-study questionnaire
measure: Parental device preference
time frame: 14 days
description: Parental device preference as determined by diary and post-study questionnaire
measure: Adverse events
time frame: 14 days
description: Description of adverse events as determined by diary and post-study questionnaire
arm group label: Bulb Aspirator
arm group type: No Intervention
description: If randomized to the bulb aspirator group, the patient will be sent home with a bulb aspirator to use for home nasal secretion management
arm group label: Nasal Oral Aspirator (NeilMed Naspira)
arm group type: Experimental
description: If randomized to the nasal oral aspirator group, patient will be sent home with a nasal oral aspirator to use for home nasal secretion management
intervention type: Device
intervention name: NeilMed Naspira
description: NeilMed Naspira is a nasal-oral aspirator
arm group label: Nasal Oral Aspirator (NeilMed Naspira)
criteria: 
gender: All
minimum age: 1 Month
maximum age: 24 Months
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas at Austin
investigator full name: Whitney Schwarz
investigator title: Principle Investigator
mesh term: Bronchiolitis
sharing ipd: Undecided