<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/NCT02219334</url>
  </required_header>
  <id_info>
    <org_study_id>H-33659</org_study_id>
    <nct_id>NCT02219334</nct_id>
  </id_info>
  <brief_title>Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study</brief_title>
  <official_title>Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of our study is to determine the safety, efficacy, length of stay and parental&#xD;
      satisfaction of the NoseFrida in comparison to a suction device used in the hospital setting&#xD;
      in patients with bronchiolitis admitted under observation status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bronchiolitis is a viral illness and a common cause for admission to the hospital. Most&#xD;
      patients with bronchiolitis are managed at home. The indications of hospitalization are poor&#xD;
      feeding (due to increased mucus production) and respiratory distress with and without&#xD;
      hypoxia. The acute care setting is a common destination of patients with bronchiolitis.&#xD;
      Patients are admitted to the acute care setting for respiratory monitoring, suctioning and&#xD;
      poor oral intake. The management of bronchiolitis is mostly supportive which includes&#xD;
      frequent feedings, nasal suctioning, intravenous fluids and oxygen if necessary. The patients&#xD;
      admitted to the acute care setting receive frequent nasal suctioning by a suction device&#xD;
      (NeoSucker) and deep suctioning as needed. Since young infants are &quot;nose breathers,&quot; the use&#xD;
      of nasal suctioning helps to relieve nasal congestion/upper airway obstruction and assists&#xD;
      with their ability to breathe and feed. Suctioning can be accomplished by the use of the bulb&#xD;
      suction, nasal aspirators and/or suction catheters connected to pressure devices.&#xD;
&#xD;
      The role of the type of suctioning device in the management of bronchiolitis has not been&#xD;
      studied extensively. In our study, a nasal aspirator (developed in Sweden by an Ear, Nose and&#xD;
      Throat specialist) by the brand name of NoseFrida will be compared to the NeoSucker, a&#xD;
      suction catheter currently used in our hospital setting which requires both a nurse and a&#xD;
      pressure device. Nasal suctioning is less traumatic and does not cause the discomfort,&#xD;
      bleeding and rebound swelling that deep suctioning can. Upon admission, patients will be&#xD;
      randomized to either the NoseFrida or NeoSucker group. After consent is obtained for agreed&#xD;
      participation, the patients parents randomized to the NoseFrida group will be given a&#xD;
      NoseFrida/filters and instructions on usage (instructional video/postcard). The parents will&#xD;
      be encouraged to use the NoseFrida suction device as often as they want, especially before&#xD;
      feeds and sleep. The patients randomized to the NeoSucker group will be given the current&#xD;
      standard of care and nasal suctioned by a nurse. Both groups will be deep suctioned as&#xD;
      clinically needed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was stopped due to low enrollment.&#xD;
  </why_stopped>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">May 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of Median Length of Stay of the Two Devices in Hours</measure>
    <time_frame>Participants will be followed for the duration of their stay in the EDOU, up to 48 Hours or end of hospitalization whichever is greater</time_frame>
    <description>The study group will analyze the length of stay for the NoseFrida group and compare it with the NeoSucker group.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Percentage of Patients Readmitted Within 48 Hours of Discharge.</measure>
    <time_frame>within 48 hours of discharge</time_frame>
    <description>The study group will analyze those patients both from the NoseFrida group and the NeoSucker group who are readmitted within 48 hours of discharge from the EDOU.</description>
  </other_outcome>
  <other_outcome>
    <measure>Parental Satisfaction (NoseFrida Group) Will be Measured Using a Newly Developed Survey Tool (Likert Scale).</measure>
    <time_frame>Participants will be followed for the duration of their stay in the EDOU, up to 48 Hours or end of hospitalization whichever is greater</time_frame>
    <description>A study specific survey was developed to measure parental satisfaction of the NoseFrida device. The parental satisfaction question responses were on a 5 point Likert Scale as follows: 1=&quot;Strongly Disagree&quot;, 2=&quot;Disagree&quot;, 3=&quot;Neutral&quot;, 4=&quot;Agree&quot; and 5=&quot;Strongly Agree.&quot; The minimum value is strongly disagree and maximum is strongly agree. The likert scale assessed parental satisfaction with the use of the device.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Bronchiolitis</condition>
  <arm_group>
    <arm_group_label>NoseFrida</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If randomized to the NoseFrida group, the NoseFrida/filters will be given along with educational instruction of its use to the parents of patients admitted with bronchiolitis. The NoseFrida will be used by the parent to suction the nares of their infants/toddlers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NeoSucker</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The NeoSucker (used for nasal suctioning) is part of the current standard of care for patients with bronchiolitis. The NeoSucker is used for removing nasal secretions by a nurse or respiratory therapist. The NeoSucker is a plastic tube which is used to suction the secretions. The bedside nurse will continue to use the NeoSucker as needed. NoseFrida will not be used for this sub group of patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NoseFrida</intervention_name>
    <description>The NoseFrida has four components, the collection container, an interchangeable filter, flexible tubing and a mouth piece. The end of the collection devise is placed on the patient's nostril, a tight seal is made via the vacuum created from suctioning of the mouth piece and secretions are easily aspirated. This device disassembles for quick disinfecting and cleaning.</description>
    <arm_group_label>NoseFrida</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients above the age of 2 months and post-gestational age to 44 weeks and less than&#xD;
             or equal to 2 years with signs and symptoms of bronchiolitis&#xD;
&#xD;
          -  clinical respiratory score (CRS) of less than or equal to 4&#xD;
&#xD;
          -  principle diagnosis of bronchiolitis (International Classification of Diseases-9: 466,&#xD;
             466.11 and 466.19)&#xD;
&#xD;
          -  Patient admitted to the Pediatric Hospitalist Medicine (PHM) group&#xD;
&#xD;
          -  Patient with associated hypoxemia and/or respiratory distress requiring low flow O2&#xD;
             nasal cannula (NC) management (2L/min or less)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age less than 2 months&#xD;
&#xD;
          -  age less than post-gestational age 44 weeks&#xD;
&#xD;
          -  CRS greater than 4&#xD;
&#xD;
          -  associated hypoxia&#xD;
&#xD;
          -  already using NoseFrida at home&#xD;
&#xD;
          -  chronic lung disease&#xD;
&#xD;
          -  oro-facial abnormalities&#xD;
&#xD;
          -  cardiac abnormalities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Months</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth L Watson, MSN, RN, CNL</last_name>
    <role>Study Director</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aderonke Adekunle-Ojo, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Benincaso FV, Smith MH. A suction-controlled nasal aspirator for collection of nasopharyngeal secretions. J Pediatr. 1973 Feb;82(2):297-9. doi: 10.1016/s0022-3476(73)80175-1. No abstract available.</citation>
    <PMID>4684375</PMID>
  </reference>
  <reference>
    <citation>Budhiraja, S., Verma, R., Shields, M.D. (2012). The management of acute bronchiolitis in infants. Paidiatrics and Child Health, 23(7), 296-300.</citation>
  </reference>
  <reference>
    <citation>Casati M, Picca M, Marinello R, Quartarone G. Safety of use, efficacy and degree of parental satisfaction with the nasal aspirator Narhinel in the treatment of nasal congestion in babies. Minerva Pediatr. 2007 Aug;59(4):315-25.</citation>
    <PMID>17947838</PMID>
  </reference>
  <reference>
    <citation>Da Dalt L, Bressan S, Martinolli F, Perilongo G, Baraldi E. Treatment of bronchiolitis: state of the art. Early Hum Dev. 2013 Jun;89 Suppl 1:S31-6. doi: 10.1016/S0378-3782(13)70011-2.</citation>
    <PMID>23809346</PMID>
  </reference>
  <reference>
    <citation>Deshpande SA, Northern V. The clinical and health economic burden of respiratory syncytial virus disease among children under 2 years of age in a defined geographical area. Arch Dis Child. 2003 Dec;88(12):1065-9. doi: 10.1136/adc.88.12.1065.</citation>
    <PMID>14670770</PMID>
  </reference>
  <reference>
    <citation>Diagnosis and Managment of Bronchiolitis., 2006. Subcommittee on Diagnosis and Management of Bronchiolitis. 118, 1774.</citation>
  </reference>
  <reference>
    <citation>Hall CB, Weinberg GA, Iwane MK, Blumkin AK, Edwards KM, Staat MA, Auinger P, Griffin MR, Poehling KA, Erdman D, Grijalva CG, Zhu Y, Szilagyi P. The burden of respiratory syncytial virus infection in young children. N Engl J Med. 2009 Feb 5;360(6):588-98. doi: 10.1056/NEJMoa0804877.</citation>
    <PMID>19196675</PMID>
  </reference>
  <reference>
    <citation>Jarvis K, Pirvu D, Barbee K, Berg N, Meyer M, Gaulke L, Pate BM, Roberts C. Change to a standardized airway clearance protocol for children with bronchiolitis leads to improved care. J Pediatr Nurs. 2014 May-Jun;29(3):252-7. doi: 10.1016/j.pedn.2013.11.007. Epub 2013 Nov 27.</citation>
    <PMID>24333327</PMID>
  </reference>
  <reference>
    <citation>Moore T. Suctioning techniques for the removal of respiratory secretions. Nurs Stand. 2003 Nov 12-18;18(9):47-53; quiz 54-5. doi: 10.7748/ns2003.11.18.9.47.c3504. Erratum In: Nurs Stand. 2003 Dec 10-16;18(13):31.</citation>
    <PMID>14649194</PMID>
  </reference>
  <reference>
    <citation>Mussman GM, Parker MW, Statile A, Sucharew H, Brady PW. Suctioning and length of stay in infants hospitalized with bronchiolitis. JAMA Pediatr. 2013 May;167(5):414-21. doi: 10.1001/jamapediatrics.2013.36.</citation>
    <PMID>23460088</PMID>
  </reference>
  <reference>
    <citation>Nagakumar P, Doull I. Current therapy for bronchiolitis. Arch Dis Child. 2012 Sep;97(9):827-30. doi: 10.1136/archdischild-2011-301579. Epub 2012 Jun 25.</citation>
    <PMID>22734014</PMID>
  </reference>
  <reference>
    <citation>Sandweiss DR, Corneli HM, Kadish HA. Barriers to discharge from a 24-hour observation unit for children with bronchiolitis. Pediatr Emerg Care. 2010 Dec;26(12):892-6. doi: 10.1097/PEC.0b013e3181fe911d.</citation>
    <PMID>21088635</PMID>
  </reference>
  <reference>
    <citation>Wai AK, Kwok WO, Chan MS, Graham CA, Rainer TH. Patients' perceptions of nasopharyngeal aspiration in the emergency department of a teaching hospital in Hong Kong. Emerg Med J. 2007 Jan;24(1):35-6. doi: 10.1136/emj.2006.039701.</citation>
    <PMID>17183041</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <results_first_submitted>May 21, 2020</results_first_submitted>
  <results_first_submitted_qc>September 1, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 3, 2020</results_first_posted>
  <last_update_submitted>September 1, 2020</last_update_submitted>
  <last_update_submitted_qc>September 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Shabana Yusuf</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Children</keyword>
  <keyword>Nasal suction devices</keyword>
  <keyword>Suctioning</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>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT02219334/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>NoseFrida</title>
          <description>If randomized to the NoseFrida group, the NoseFrida/filters will be given along with educational instruction of its use to the parents of patients admitted with bronchiolitis. The NoseFrida will be used by the parent to suction the nares of their infants/toddlers.&#xD;
NoseFrida: The NoseFrida has four components, the collection container, an interchangeable filter, flexible tubing and a mouth piece. The end of the collection devise is placed on the patient's nostril, a tight seal is made via the vacuum created from suctioning of the mouth piece and secretions are easily aspirated. This device disassembles for quick disinfecting and cleaning.</description>
        </group>
        <group group_id="P2">
          <title>NeoSucker</title>
          <description>The NeoSucker (used for nasal suctioning) is part of the current standard of care for patients with bronchiolitis. The NeoSucker is used for removing nasal secretions by a nurse or respiratory therapist. The NeoSucker is a plastic tube which is used to suction the secretions. The bedside nurse will continue to use the NeoSucker as needed. NoseFrida will not be used for this sub group of patients.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>NoseFrida</title>
          <description>If randomized to the NoseFrida group, the NoseFrida/filters will be given along with educational instruction of its use to the parents of patients admitted with bronchiolitis. The NoseFrida will be used by the parent to suction the nares of their infants/toddlers.&#xD;
NoseFrida: The NoseFrida has four components, the collection container, an interchangeable filter, flexible tubing and a mouth piece. The end of the collection devise is placed on the patient's nostril, a tight seal is made via the vacuum created from suctioning of the mouth piece and secretions are easily aspirated. This device disassembles for quick disinfecting and cleaning.</description>
        </group>
        <group group_id="B2">
          <title>NeoSucker</title>
          <description>The NeoSucker (used for nasal suctioning) is part of the current standard of care for patients with bronchiolitis. The NeoSucker is used for removing nasal secretions by a nurse or respiratory therapist. The NeoSucker is a plastic tube which is used to suction the secretions. The bedside nurse will continue to use the NeoSucker as needed. NoseFrida will not be used for this sub group of patients.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="44"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Length of stay</title>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.23" lower_limit="17.63" upper_limit="40.48"/>
                    <measurement group_id="B2" value="25.13" lower_limit="19.70" upper_limit="45.42"/>
                    <measurement group_id="B3" value="25.93" lower_limit="19.48" upper_limit="43.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Comparison of Median Length of Stay of the Two Devices in Hours</title>
        <description>The study group will analyze the length of stay for the NoseFrida group and compare it with the NeoSucker group.</description>
        <time_frame>Participants will be followed for the duration of their stay in the EDOU, up to 48 Hours or end of hospitalization whichever is greater</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NoseFrida</title>
            <description>If randomized to the NoseFrida group, the NoseFrida/filters will be given along with educational instruction of its use to the parents of patients admitted with bronchiolitis. The NoseFrida will be used by the parent to suction the nares of their infants/toddlers.&#xD;
NoseFrida: The NoseFrida has four components, the collection container, an interchangeable filter, flexible tubing and a mouth piece. The end of the collection devise is placed on the patient's nostril, a tight seal is made via the vacuum created from suctioning of the mouth piece and secretions are easily aspirated. This device disassembles for quick disinfecting and cleaning.</description>
          </group>
          <group group_id="O2">
            <title>NeoSucker</title>
            <description>The NeoSucker (used for nasal suctioning) is part of the current standard of care for patients with bronchiolitis. The NeoSucker is used for removing nasal secretions by a nurse or respiratory therapist. The NeoSucker is a plastic tube which is used to suction the secretions. The bedside nurse will continue to use the NeoSucker as needed. NoseFrida will not be used for this sub group of patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of Median Length of Stay of the Two Devices in Hours</title>
          <description>The study group will analyze the length of stay for the NoseFrida group and compare it with the NeoSucker group.</description>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.23" lower_limit="17.63" upper_limit="40.48"/>
                    <measurement group_id="O2" value="25.13" lower_limit="19.70" upper_limit="45.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The primary hypothesis of length of stay equivalence within a margin of ± 5 hours was tested using the two one-sided t-test (TOST) procedure, with a 5% significance level.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Historical data at the institution for similar patients had a mean length of stay(LOS) of 25.7 hours (standard deviation-[SD] =10.3) from 9/2012- 9/13 was observed for 134 patients admitted to the emergency department observation unit and treated with the standard of care (NeoSucker). Given a LOS-SD of 10.3 hours, 75 subjects per treatment group would provide 80% statistical power at the 5% significance level to demonstrate equivalence in the two treatments' length of stay within ±5 hours.</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>two one-sided t-test (TOST)</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.49</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>21.4</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.74</ci_lower_limit>
            <ci_upper_limit>15.72</ci_upper_limit>
            <estimate_desc>Due to slower than anticipated patient recruitment, the target size of 75 participants per treatment group was not reached.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Patients Readmitted Within 48 Hours of Discharge.</title>
        <description>The study group will analyze those patients both from the NoseFrida group and the NeoSucker group who are readmitted within 48 hours of discharge from the EDOU.</description>
        <time_frame>within 48 hours of discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NoseFrida</title>
            <description>If randomized to the NoseFrida group, the NoseFrida/filters will be given along with educational instruction of its use to the parents of patients admitted with bronchiolitis. The NoseFrida will be used by the parent to suction the nares of their infants/toddlers.&#xD;
NoseFrida: The NoseFrida has four components, the collection container, an interchangeable filter, flexible tubing and a mouth piece. The end of the collection devise is placed on the patient's nostril, a tight seal is made via the vacuum created from suctioning of the mouth piece and secretions are easily aspirated. This device disassembles for quick disinfecting and cleaning.</description>
          </group>
          <group group_id="O2">
            <title>NeoSucker</title>
            <description>The NeoSucker (used for nasal suctioning) is part of the current standard of care for patients with bronchiolitis. The NeoSucker is used for removing nasal secretions by a nurse or respiratory therapist. The NeoSucker is a plastic tube which is used to suction the secretions. The bedside nurse will continue to use the NeoSucker as needed. NoseFrida will not be used for this sub group of patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Readmitted Within 48 Hours of Discharge.</title>
          <description>The study group will analyze those patients both from the NoseFrida group and the NeoSucker group who are readmitted within 48 hours of discharge from the EDOU.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Parental Satisfaction (NoseFrida Group) Will be Measured Using a Newly Developed Survey Tool (Likert Scale).</title>
        <description>A study specific survey was developed to measure parental satisfaction of the NoseFrida device. The parental satisfaction question responses were on a 5 point Likert Scale as follows: 1=&quot;Strongly Disagree&quot;, 2=&quot;Disagree&quot;, 3=&quot;Neutral&quot;, 4=&quot;Agree&quot; and 5=&quot;Strongly Agree.&quot; The minimum value is strongly disagree and maximum is strongly agree. The likert scale assessed parental satisfaction with the use of the device.</description>
        <time_frame>Participants will be followed for the duration of their stay in the EDOU, up to 48 Hours or end of hospitalization whichever is greater</time_frame>
        <population>Parental satisfaction survey was only done on Nosefrida group since the Neosucker is the standard of care</population>
        <group_list>
          <group group_id="O1">
            <title>NoseFrida</title>
            <description>If randomized to the NoseFrida group, the NoseFrida/filters will be given along with educational instruction of its use to the parents of patients admitted with bronchiolitis. The NoseFrida will be used by the parent to suction the nares of their infants/toddlers.&#xD;
NoseFrida: The NoseFrida has four components, the collection container, an interchangeable filter, flexible tubing and a mouth piece. The end of the collection devise is placed on the patient's nostril, a tight seal is made via the vacuum created from suctioning of the mouth piece and secretions are easily aspirated. This device disassembles for quick disinfecting and cleaning.</description>
          </group>
          <group group_id="O2">
            <title>NeoSucker</title>
            <description>The NeoSucker (used for nasal suctioning) is part of the current standard of care for patients with bronchiolitis. The NeoSucker is used for removing nasal secretions by a nurse or respiratory therapist. The NeoSucker is a plastic tube which is used to suction the secretions. The bedside nurse will continue to use the NeoSucker as needed. NoseFrida will not be used for this sub group of patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Parental Satisfaction (NoseFrida Group) Will be Measured Using a Newly Developed Survey Tool (Likert Scale).</title>
          <description>A study specific survey was developed to measure parental satisfaction of the NoseFrida device. The parental satisfaction question responses were on a 5 point Likert Scale as follows: 1=&quot;Strongly Disagree&quot;, 2=&quot;Disagree&quot;, 3=&quot;Neutral&quot;, 4=&quot;Agree&quot; and 5=&quot;Strongly Agree.&quot; The minimum value is strongly disagree and maximum is strongly agree. The likert scale assessed parental satisfaction with the use of the device.</description>
          <population>Parental satisfaction survey was only done on Nosefrida group since the Neosucker is the standard of care</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="1" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse reaction was monitored throughout the hospital stay &quot;an average of 26 hours&quot; till the patient was discharged. No adverse event monitoring was done after discharge.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>NoseFrida</title>
          <description>If randomized to the NoseFrida group, the NoseFrida/filters will be given along with educational instruction of its use to the parents of patients admitted with bronchiolitis. The NoseFrida will be used by the parent to suction the nares of their infants/toddlers.&#xD;
NoseFrida: The NoseFrida has four components, the collection container, an interchangeable filter, flexible tubing and a mouth piece. The end of the collection devise is placed on the patient's nostril, a tight seal is made via the vacuum created from suctioning of the mouth piece and secretions are easily aspirated. This device disassembles for quick disinfecting and cleaning.</description>
        </group>
        <group group_id="E2">
          <title>NeoSucker</title>
          <description>The NeoSucker (used for nasal suctioning) is part of the current standard of care for patients with bronchiolitis. The NeoSucker is used for removing nasal secretions by a nurse or respiratory therapist. The NeoSucker is a plastic tube which is used to suction the secretions. The bedside nurse will continue to use the NeoSucker as needed. NoseFrida will not be used for this sub group of patients.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The sample size was small and was a convenience sample. Not all parents participated in the satisfaction survey. The lack of documentation of nose bleeds and nasal swelling does not suggest the absence of these minor side effects.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Shabana Yusuf/Associate Professor of Pediatrics</name_or_title>
      <organization>Baylor College of Medicine</organization>
      <phone>832-824-5388</phone>
      <email>syusuf@bcm.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02219334
org study id: H-33659
nct id: NCT02219334
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of our study is to determine the safety, efficacy, length of stay and parental
      satisfaction of the NoseFrida in comparison to a suction device used in the hospital setting
      in patients with bronchiolitis admitted under observation status.
Bronchiolitis is a viral illness and a common cause for admission to the hospital. Most
      patients with bronchiolitis are managed at home. The indications of hospitalization are poor
      feeding (due to increased mucus production) and respiratory distress with and without
      hypoxia. The acute care setting is a common destination of patients with bronchiolitis.
      Patients are admitted to the acute care setting for respiratory monitoring, suctioning and
      poor oral intake. The management of bronchiolitis is mostly supportive which includes
      frequent feedings, nasal suctioning, intravenous fluids and oxygen if necessary. The patients
      admitted to the acute care setting receive frequent nasal suctioning by a suction device
      (NeoSucker) and deep suctioning as needed. Since young infants are "nose breathers," the use
      of nasal suctioning helps to relieve nasal congestion/upper airway obstruction and assists
      with their ability to breathe and feed. Suctioning can be accomplished by the use of the bulb
      suction, nasal aspirators and/or suction catheters connected to pressure devices.

      The role of the type of suctioning device in the management of bronchiolitis has not been
      studied extensively. In our study, a nasal aspirator (developed in Sweden by an Ear, Nose and
      Throat specialist) by the brand name of NoseFrida will be compared to the NeoSucker, a
      suction catheter currently used in our hospital setting which requires both a nurse and a
      pressure device. Nasal suctioning is less traumatic and does not cause the discomfort,
      bleeding and rebound swelling that deep suctioning can. Upon admission, patients will be
      randomized to either the NoseFrida or NeoSucker group. After consent is obtained for agreed
      participation, the patients parents randomized to the NoseFrida group will be given a
      NoseFrida/filters and instructions on usage (instructional video/postcard). The parents will
      be encouraged to use the NoseFrida suction device as often as they want, especially before
      feeds and sleep. The patients randomized to the NeoSucker group will be given the current
      standard of care and nasal suctioned by a nurse. Both groups will be deep suctioned as
      clinically needed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Comparison of Median Length of Stay of the Two Devices in Hours
time frame: Participants will be followed for the duration of their stay in the EDOU, up to 48 Hours or end of hospitalization whichever is greater
description: The study group will analyze the length of stay for the NoseFrida group and compare it with the NeoSucker group.
measure: Percentage of Patients Readmitted Within 48 Hours of Discharge.
time frame: within 48 hours of discharge
description: The study group will analyze those patients both from the NoseFrida group and the NeoSucker group who are readmitted within 48 hours of discharge from the EDOU.
measure: Parental Satisfaction (NoseFrida Group) Will be Measured Using a Newly Developed Survey Tool (Likert Scale).
time frame: Participants will be followed for the duration of their stay in the EDOU, up to 48 Hours or end of hospitalization whichever is greater
description: A study specific survey was developed to measure parental satisfaction of the NoseFrida device. The parental satisfaction question responses were on a 5 point Likert Scale as follows: 1="Strongly Disagree", 2="Disagree", 3="Neutral", 4="Agree" and 5="Strongly Agree." The minimum value is strongly disagree and maximum is strongly agree. The likert scale assessed parental satisfaction with the use of the device.
arm group label: NoseFrida
arm group type: Experimental
description: If randomized to the NoseFrida group, the NoseFrida/filters will be given along with educational instruction of its use to the parents of patients admitted with bronchiolitis. The NoseFrida will be used by the parent to suction the nares of their infants/toddlers.
arm group label: NeoSucker
arm group type: No Intervention
description: The NeoSucker (used for nasal suctioning) is part of the current standard of care for patients with bronchiolitis. The NeoSucker is used for removing nasal secretions by a nurse or respiratory therapist. The NeoSucker is a plastic tube which is used to suction the secretions. The bedside nurse will continue to use the NeoSucker as needed. NoseFrida will not be used for this sub group of patients.
intervention type: Device
intervention name: NoseFrida
description: The NoseFrida has four components, the collection container, an interchangeable filter, flexible tubing and a mouth piece. The end of the collection devise is placed on the patient's nostril, a tight seal is made via the vacuum created from suctioning of the mouth piece and secretions are easily aspirated. This device disassembles for quick disinfecting and cleaning.
arm group label: NoseFrida
criteria: 
gender: All
minimum age: 2 Months
maximum age: 2 Years
healthy volunteers: No
last name: Elizabeth L Watson, MSN, RN, CNL
role: Study Director
affiliation: Baylor College of Medicine
last name: Aderonke Adekunle-Ojo, MD
role: Study Chair
affiliation: Baylor College of Medicine
facility: 
country: United States
citation: Benincaso FV, Smith MH. A suction-controlled nasal aspirator for collection of nasopharyngeal secretions. J Pediatr. 1973 Feb;82(2):297-9. doi: 10.1016/s0022-3476(73)80175-1. No abstract available.
PMID: 4684375
citation: Budhiraja, S., Verma, R., Shields, M.D. (2012). The management of acute bronchiolitis in infants. Paidiatrics and Child Health, 23(7), 296-300.
citation: Casati M, Picca M, Marinello R, Quartarone G. Safety of use, efficacy and degree of parental satisfaction with the nasal aspirator Narhinel in the treatment of nasal congestion in babies. Minerva Pediatr. 2007 Aug;59(4):315-25.
PMID: 17947838
citation: Da Dalt L, Bressan S, Martinolli F, Perilongo G, Baraldi E. Treatment of bronchiolitis: state of the art. Early Hum Dev. 2013 Jun;89 Suppl 1:S31-6. doi: 10.1016/S0378-3782(13)70011-2.
PMID: 23809346
citation: Deshpande SA, Northern V. The clinical and health economic burden of respiratory syncytial virus disease among children under 2 years of age in a defined geographical area. Arch Dis Child. 2003 Dec;88(12):1065-9. doi: 10.1136/adc.88.12.1065.
PMID: 14670770
citation: Diagnosis and Managment of Bronchiolitis., 2006. Subcommittee on Diagnosis and Management of Bronchiolitis. 118, 1774.
citation: Hall CB, Weinberg GA, Iwane MK, Blumkin AK, Edwards KM, Staat MA, Auinger P, Griffin MR, Poehling KA, Erdman D, Grijalva CG, Zhu Y, Szilagyi P. The burden of respiratory syncytial virus infection in young children. N Engl J Med. 2009 Feb 5;360(6):588-98. doi: 10.1056/NEJMoa0804877.
PMID: 19196675
citation: Jarvis K, Pirvu D, Barbee K, Berg N, Meyer M, Gaulke L, Pate BM, Roberts C. Change to a standardized airway clearance protocol for children with bronchiolitis leads to improved care. J Pediatr Nurs. 2014 May-Jun;29(3):252-7. doi: 10.1016/j.pedn.2013.11.007. Epub 2013 Nov 27.
PMID: 24333327
citation: Moore T. Suctioning techniques for the removal of respiratory secretions. Nurs Stand. 2003 Nov 12-18;18(9):47-53; quiz 54-5. doi: 10.7748/ns2003.11.18.9.47.c3504. Erratum In: Nurs Stand. 2003 Dec 10-16;18(13):31.
PMID: 14649194
citation: Mussman GM, Parker MW, Statile A, Sucharew H, Brady PW. Suctioning and length of stay in infants hospitalized with bronchiolitis. JAMA Pediatr. 2013 May;167(5):414-21. doi: 10.1001/jamapediatrics.2013.36.
PMID: 23460088
citation: Nagakumar P, Doull I. Current therapy for bronchiolitis. Arch Dis Child. 2012 Sep;97(9):827-30. doi: 10.1136/archdischild-2011-301579. Epub 2012 Jun 25.
PMID: 22734014
citation: Sandweiss DR, Corneli HM, Kadish HA. Barriers to discharge from a 24-hour observation unit for children with bronchiolitis. Pediatr Emerg Care. 2010 Dec;26(12):892-6. doi: 10.1097/PEC.0b013e3181fe911d.
PMID: 21088635
citation: Wai AK, Kwok WO, Chan MS, Graham CA, Rainer TH. Patients' perceptions of nasopharyngeal aspiration in the emergency department of a teaching hospital in Hong Kong. Emerg Med J. 2007 Jan;24(1):35-6. doi: 10.1136/emj.2006.039701.
PMID: 17183041
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Shabana Yusuf
investigator title: Principal Investigator
mesh term: Bronchiolitis
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The sample size was small and was a convenience sample. Not all parents participated in the satisfaction survey. The lack of documentation of nose bleeds and nasal swelling does not suggest the absence of these minor side effects.
point of contact: 