<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/NCT04480970</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 261122</org_study_id>
    <nct_id>NCT04480970</nct_id>
  </id_info>
  <brief_title>Placement of Nasogastric Tubes for Gastric Decompression in Patients With Bronchiolitis</brief_title>
  <official_title>Placement of Nasogastric Tubes for Gastric Decompression in Patients With Bronchiolitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arkansas Children's Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arkansas Children's Hospital Research Institute</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate whether placing nasogastric tubes for gastric decompression&#xD;
      improves respiratory distress for patients with bronchiolitis who are receiving oxygen via&#xD;
      high-flow nasal cannula.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients will be consented per IRB procedure. The study will be a prospective study.&#xD;
      Study participants will be enrolled after placement on high flow nasal cannula. The&#xD;
      respiratory therapist or study staff will use a bronchiolitis scoring tool, the Marlais Risk&#xD;
      of Admission Score, to assess the respiratory status of patients after placement on high flow&#xD;
      nasal cannula, and prior to placement of NG tube to establish a baseline measurement. This&#xD;
      tool includes the following components: respiratory rate, oxygen saturation, heart rate, age,&#xD;
      and length of illness. An NG tube will then be placed. Thirty minutes and sixty minutes after&#xD;
      placement of the NG tube, the respiratory therapist or study team will again use this scoring&#xD;
      tool to assess the respiratory status of the patient. After 60 minutes the study will be&#xD;
      concluded. As subject will be requiring oxygen use, admission to an inpatient unit is&#xD;
      required. The NG tube will be removed at the discretion of the provider or the admitting&#xD;
      physician, who may choose to keep it in at their discretion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2024</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Respiratory status</measure>
    <time_frame>60 minutes</time_frame>
    <description>A bronchiolitis scoring tool, the Marlais Risk of Admission Score, will be used to assess the respiratory status of patients. This tool includes the following components: respiratory rate, oxygen saturation, heart rate, age, and length of illness.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Bronchiolitis</condition>
  <arm_group>
    <arm_group_label>Nasogastric tube placement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nasogastric tube placement</intervention_name>
    <description>All patients enrolled in the study will have a nasogastric tube placed for gastric decompression.</description>
    <arm_group_label>Nasogastric tube placement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of bronchiolitis by the attending physician&#xD;
&#xD;
          -  On high flow nasal cannula (4 liters or greater)&#xD;
&#xD;
          -  Ages 0 months to 23 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of bacterial pneumonia&#xD;
&#xD;
          -  History of cranio-facial anomalies&#xD;
&#xD;
          -  History of congenital heart disease&#xD;
&#xD;
          -  History of G-tube dependence&#xD;
&#xD;
          -  History of short gut syndrome&#xD;
&#xD;
          -  History of tracheostomy or current tracheostomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>23 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Spiro, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>AR Children's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Leroy Crawley, MS</last_name>
    <phone>5013643481</phone>
    <email>crawleylj@archildrens.org</email>
  </overall_contact>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Leroy Crawley, MS</last_name>
      <phone>501-364-3481</phone>
      <email>crawleylj@archildrens.org</email>
    </contact>
    <contact_backup>
      <last_name>David Spiro, MD, MPH</last_name>
      <phone>5013641050</phone>
      <email>dmspiro@uams.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>February 21, 2023</last_update_submitted>
  <last_update_submitted_qc>February 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</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/NCT04480970
org study id: IRB 261122
nct id: NCT04480970
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This study aims to evaluate whether placing nasogastric tubes for gastric decompression
      improves respiratory distress for patients with bronchiolitis who are receiving oxygen via
      high-flow nasal cannula.
All patients will be consented per IRB procedure. The study will be a prospective study.
      Study participants will be enrolled after placement on high flow nasal cannula. The
      respiratory therapist or study staff will use a bronchiolitis scoring tool, the Marlais Risk
      of Admission Score, to assess the respiratory status of patients after placement on high flow
      nasal cannula, and prior to placement of NG tube to establish a baseline measurement. This
      tool includes the following components: respiratory rate, oxygen saturation, heart rate, age,
      and length of illness. An NG tube will then be placed. Thirty minutes and sixty minutes after
      placement of the NG tube, the respiratory therapist or study team will again use this scoring
      tool to assess the respiratory status of the patient. After 60 minutes the study will be
      concluded. As subject will be requiring oxygen use, admission to an inpatient unit is
      required. The NG tube will be removed at the discretion of the provider or the admitting
      physician, who may choose to keep it in at their discretion.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Respiratory status
time frame: 60 minutes
description: A bronchiolitis scoring tool, the Marlais Risk of Admission Score, will be used to assess the respiratory status of patients. This tool includes the following components: respiratory rate, oxygen saturation, heart rate, age, and length of illness.
arm group label: Nasogastric tube placement
arm group type: Experimental
intervention type: Device
intervention name: Nasogastric tube placement
description: All patients enrolled in the study will have a nasogastric tube placed for gastric decompression.
arm group label: Nasogastric tube placement
criteria: 
gender: All
minimum age: 1 Day
maximum age: 23 Months
healthy volunteers: Accepts Healthy Volunteers
last name: David Spiro, MD, MPH
role: Principal Investigator
affiliation: AR Children's Hospital
last name: Leroy Crawley, MS
phone: 5013643481
email: crawleylj@archildrens.org
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Bronchiolitis