<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/NCT02233985</url>
  </required_header>
  <id_info>
    <org_study_id>R-2012-1002-43</org_study_id>
    <nct_id>NCT02233985</nct_id>
  </id_info>
  <brief_title>Nebulized 3% Hypertonic Saline Solution Treatment of Bronchiolitis in Infants</brief_title>
  <official_title>A Randomized Trial of Nebulized 3% Hypertonic Saline With Salbutamol in the Treatment of Acute Bronchiolitis in Pediatric Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coordinación de Investigación en Salud, Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Coordinación de Investigación en Salud, Mexico</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      - Determine the efficacy of nebulized salbutamol/hypertonic saline combination in moderate to&#xD;
      severe bronchiolitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Study design: double-blind, randomized, parallel-controlled prospective study.&#xD;
&#xD;
        -  Location: Department of pediatric emergencies and pediatric hospitalization of Highly&#xD;
           Specialized Medical Unit (HSMU), Hospital of Gynecology-Obstetrics and Paediatrics&#xD;
           (HGOP) No. 48, Mexican Institute of Social Security (MISS).&#xD;
&#xD;
        -  Patients: 50 patients were included; 25 for each group. Patients had between 2 and 24&#xD;
           months of age with a first episode of wheezing associated with respiratory distress and&#xD;
           a history of infection of the upper respiratory tract, with moderate to severe degree of&#xD;
           respiratory distress according to the Respiratory Distress Scale of Sant Joan de Déu&#xD;
           Hospital (SJDH) .&#xD;
&#xD;
        -  Interventions: the randomly allocated patients received in group I nebulised 0.9% saline&#xD;
           with salbutamol 100 micrograms / kg / dose for 3 initial sessions lasting 20 minutes&#xD;
           each and every 4 hours. In group II , hypertonic (3%) saline plus salbutamol 100&#xD;
           micrograms / kg / dose for 3 initial sessions lasting 20 minutes each and every 4 hours.&#xD;
           In both groups, will be performed at baseline Scale SJDH Respiratory Distress and the&#xD;
           end of the first 3 sessions, you will have 30 minutes to make the second evaluation and&#xD;
           at 4 hours the third at 8 hours and then every 24 hours throughout the hospital stay .&#xD;
           The independent variable is the intervention with hypertonic saline 3% and the variable&#xD;
           primary outcome will be assessed improvement or cure with Respiratory Distress Scale&#xD;
           SJDH and secondary outcome will be the time of hospital stay .&#xD;
&#xD;
        -  Descriptive statistics of all variables will be reported. T test was used for two&#xD;
           independent groups or nonparametric test according to the distribution of the variables&#xD;
           to compare the clinical improvement between the groups with the Scale of Respiratory&#xD;
           Distress SJDH, as well as to determine whether there is a difference in time of hospital&#xD;
           stay between the two study groups. Square test or Fisher exact chi used to compare&#xD;
           readmissions for bronchial hyperresponsiveness between the two groups as well as the&#xD;
           complications of the disease itself in each study group. Be reported with frequencies&#xD;
           and percentages side effects of hypertonic saline 3%. Was considered statistically&#xD;
           significant p &lt;0.05. The results with the Number Cruncher Statistical System (NCSS) 2004&#xD;
           statistical program will be discussed.&#xD;
&#xD;
        -  The sample size was calculated with t-test to compare means of continuous variables,&#xD;
           resulting in 25 subjects per group.&#xD;
&#xD;
        -  In the follow-up period it was possible to obtain more patients from the baseline&#xD;
           estimate of the sample number.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Score Respiratory Distress</measure>
    <time_frame>Basal, 30 minutes after the end of the first 3 continuous nebulization sessions, at 4 hours, 8 hours and every 24 hours during the entire hospital stay</time_frame>
    <description>It is a validated clinical scale, sufficiently reliable measure of Severity of the respiratory distress. It consists of the summation score of the sibilance / crackling parameters (the largest of them), respiratory effort, pulmonary air inlet, oxygen saturation, heart rate and breathing rate. It is stratified into 3 levels of severity: mild from 0 to 5 points, moderate from 6 to 10 and severe from 10 to 16.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hours of Hospital Stay</measure>
    <time_frame>Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.</time_frame>
    <description>Each patient record the time of entry and measured the total hospital stay time in hours, recording the time of discharge to determine the total stay in hours. The hospital stay will be evaluated in hours. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Readmission</measure>
    <time_frame>Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.</time_frame>
    <description>After the first admission of each patient will be evaluated during the next 30 days, if a patient is readmitted for any respiratory disease, respiratory distress, pneumonia or bronchiolitis. Considering as non-serious risks that do not compromise life, tachycardia, tremor, increased access to cough immediately to the inhalation, as well as the ardor of nasal mucosa, all these with limited characteristics, however, these do not put at risk The health of the patient, so they were not measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Complications of the Disease Itself</measure>
    <time_frame>Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.</time_frame>
    <description>The presence or absence of clinical data to warrant dehydration of hydration, infected by bacteria, pneumothorax, interstitial emphysema and subcutaneous be evaluated.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Bronchiolitis</condition>
  <condition>Wheezing</condition>
  <arm_group>
    <arm_group_label>Nebulized 0.9% Sodium Chloride</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nebulized 3% Sodium Chloride</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.9% Sodium Chloride</intervention_name>
    <description>Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.</description>
    <arm_group_label>Nebulized 0.9% Sodium Chloride</arm_group_label>
    <other_name>0.9% saline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>3% Sodium Chloride</intervention_name>
    <description>Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.</description>
    <arm_group_label>Nebulized 3% Sodium Chloride</arm_group_label>
    <other_name>3% saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All pediatric patients aged 2 months to 24 months of age, both genders attending the&#xD;
             pediatric emergency service.&#xD;
&#xD;
          -  With first episode of wheezing associated with respiratory distress and a history of&#xD;
             upper respiratory tract infection.&#xD;
&#xD;
          -  You have the evaluation of respiratory difficulty with Scale Hospital Sant Joan de Deu&#xD;
             (HSJD) from 6 to 16 at entry points (moderate and severe degree).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a history of previous wheezing, asthma, or who have received&#xD;
             bronchodilator treatment before the present illness.&#xD;
&#xD;
          -  Subjects with chronic lung disease, with heart disease, with congenital or acquired&#xD;
             anatomic abnormalities of the airway.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Months</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gloria P Sosa-Bustamante, MD</last_name>
    <role>Study Director</role>
    <affiliation>Unidad Medica de Alta Especialidad Bajio 48. Hospital de Gineco - Pediatria. Instituto Mexicano del Seguro Social</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Unidad Medica de Alta Especialidad Bajío No. 48 Hospital de Gineco - Pediatría. Instituto Mexicano del Seguro Social</name>
      <address>
        <city>Leon</city>
        <state>Guanajuato</state>
        <zip>37320</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <link>
    <url>http://www.nottingham.ac.uk/paediatric-guideline/breathingguideline.pdf</url>
    <description>Guideline for the Management of Children Presenting With Acute Breathing Difficulty. Nottingham, United Kingdom: University of Nottingham</description>
  </link>
  <reference>
    <citation>Kuzik BA, Flavin MP, Kent S, Zielinski D, Kwan CW, Adeleye A, Vegsund BC, Rossi C. Effect of inhaled hypertonic saline on hospital admission rate in children with viral bronchiolitis: a randomized trial. CJEM. 2010 Nov;12(6):477-84. doi: 10.1017/s1481803500012690.</citation>
    <PMID>21073773</PMID>
  </reference>
  <reference>
    <citation>Sharma BS, Gupta MK, Rafik SP. Hypertonic (3%) saline vs 0.93% saline nebulization for acute viral bronchiolitis: a randomized controlled trial. Indian Pediatr. 2013 Aug;50(8):743-7. doi: 10.1007/s13312-013-0216-8. Epub 2012 Dec 5.</citation>
    <PMID>23502662</PMID>
  </reference>
  <reference>
    <citation>Gupta N, Puliyel A, Manchanda A, Puliyel J. Nebulized hypertonic-saline vs epinephrine for bronchiolitis; proof of concept study of cumulative sum (CUSUM) analysis. Indian Pediatr. 2012 Jul;49(7):543-7. doi: 10.1007/s13312-012-0122-5. Epub 2010 Oct 30.</citation>
    <PMID>22080619</PMID>
  </reference>
  <reference>
    <citation>Al-Ansari K, Sakran M, Davidson BL, El Sayyed R, Mahjoub H, Ibrahim K. Nebulized 5% or 3% hypertonic or 0.9% saline for treating acute bronchiolitis in infants. J Pediatr. 2010 Oct;157(4):630-4, 634.e1. doi: 10.1016/j.jpeds.2010.04.074. Epub 2010 Jun 19.</citation>
    <PMID>20646715</PMID>
  </reference>
  <reference>
    <citation>Luo Z, Fu Z, Liu E, Xu X, Fu X, Peng D, Liu Y, Li S, Zeng F, Yang X. Nebulized hypertonic saline treatment in hospitalized children with moderate to severe viral bronchiolitis. Clin Microbiol Infect. 2011 Dec;17(12):1829-33. doi: 10.1111/j.1469-0691.2010.03304.x. Epub 2010 Jul 15.</citation>
    <PMID>20636429</PMID>
  </reference>
  <reference>
    <citation>Grewal S, Ali S, McConnell DW, Vandermeer B, Klassen TP. A randomized trial of nebulized 3% hypertonic saline with epinephrine in the treatment of acute bronchiolitis in the emergency department. Arch Pediatr Adolesc Med. 2009 Nov;163(11):1007-12. doi: 10.1001/archpediatrics.2009.196.</citation>
    <PMID>19884591</PMID>
  </reference>
  <reference>
    <citation>Luo Z, Liu E, Luo J, Li S, Zeng F, Yang X, Fu Z. Nebulized hypertonic saline/salbutamol solution treatment in hospitalized children with mild to moderate bronchiolitis. Pediatr Int. 2010 Apr;52(2):199-202. doi: 10.1111/j.1442-200X.2009.02941.x. Epub 2009 Aug 7.</citation>
    <PMID>19674354</PMID>
  </reference>
  <reference>
    <citation>Postiaux G, Louis J, Labasse HC, Gerroldt J, Kotik AC, Lemuhot A, Patte C. Evaluation of an alternative chest physiotherapy method in infants with respiratory syncytial virus bronchiolitis. Respir Care. 2011 Jul;56(7):989-94. doi: 10.4187/respcare.00721. Epub 2011 Feb 22.</citation>
    <PMID>21352671</PMID>
  </reference>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>May 7, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>April 18, 2016</results_first_submitted>
  <results_first_submitted_qc>January 25, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 15, 2017</results_first_posted>
  <last_update_submitted>May 29, 2017</last_update_submitted>
  <last_update_submitted_qc>May 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bronchiolitis</keyword>
  <keyword>hypertonic</keyword>
  <keyword>saline</keyword>
  <keyword>salbutamol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</mesh_term>
    <mesh_term>Respiratory Sounds</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We have your membership number social security and personal data such as address and telephone number of the parents.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Nebulized 0.9% Sodium Chloride</title>
          <description>Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.&#xD;
0.9% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.</description>
        </group>
        <group group_id="P2">
          <title>Nebulized 3% Sodium Chloride</title>
          <description>Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.&#xD;
3% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>In the follow-up period it was possible to obtain more patients from the baseline estimate of the sample number.</population>
      <group_list>
        <group group_id="B1">
          <title>Nebulized 0.9% Sodium Chloride</title>
          <description>Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.&#xD;
0.9% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.</description>
        </group>
        <group group_id="B2">
          <title>Nebulized 3% Sodium Chloride</title>
          <description>Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.&#xD;
3% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.</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="33"/>
            <count group_id="B2" value="31"/>
            <count group_id="B3" value="64"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.7" spread="5.7"/>
                    <measurement group_id="B2" value="8.8" spread="5.7"/>
                    <measurement group_id="B3" value="8.2" spread="5.5"/>
                  </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="17"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="36"/>
                  </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="33"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Mexico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Score Respiratory Distress</title>
        <description>It is a validated clinical scale, sufficiently reliable measure of Severity of the respiratory distress. It consists of the summation score of the sibilance / crackling parameters (the largest of them), respiratory effort, pulmonary air inlet, oxygen saturation, heart rate and breathing rate. It is stratified into 3 levels of severity: mild from 0 to 5 points, moderate from 6 to 10 and severe from 10 to 16.</description>
        <time_frame>Basal, 30 minutes after the end of the first 3 continuous nebulization sessions, at 4 hours, 8 hours and every 24 hours during the entire hospital stay</time_frame>
        <population>All patients with respiratory distress in moderate to severe stage until a stage of mild respiratory distress or difficulty breathing submitted.</population>
        <group_list>
          <group group_id="O1">
            <title>Hypertonic Saline Solution 3% (HSS 3%) Group</title>
            <description>Patients with moderate stages (6 to 10 points) and severe (11 to 16 points) were selected, performing subsequent measurements always 30 minutes after nebulization corresponding.</description>
          </group>
          <group group_id="O2">
            <title>Saline Solution 0.9% (SS 0.9%) Group</title>
            <description>Patients with moderate stages (6 to 10 points) and severe (11 to 16 points) were selected, performing subsequent measurements always 30 minutes after nebulization corresponding.</description>
          </group>
        </group_list>
        <measure>
          <title>Score Respiratory Distress</title>
          <description>It is a validated clinical scale, sufficiently reliable measure of Severity of the respiratory distress. It consists of the summation score of the sibilance / crackling parameters (the largest of them), respiratory effort, pulmonary air inlet, oxygen saturation, heart rate and breathing rate. It is stratified into 3 levels of severity: mild from 0 to 5 points, moderate from 6 to 10 and severe from 10 to 16.</description>
          <population>All patients with respiratory distress in moderate to severe stage until a stage of mild respiratory distress or difficulty breathing submitted.</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Basal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="7" upper_limit="10"/>
                    <measurement group_id="O2" value="8" lower_limit="8" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="5" upper_limit="7"/>
                    <measurement group_id="O2" value="8" lower_limit="8" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="3" upper_limit="6"/>
                    <measurement group_id="O2" value="8" lower_limit="7" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="3" upper_limit="5"/>
                    <measurement group_id="O2" value="8" lower_limit="6" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="2" upper_limit="7"/>
                    <measurement group_id="O2" value="7" lower_limit="6" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="7" lower_limit="6" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="7" lower_limit="6" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="6" lower_limit="3" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>96 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="5" lower_limit="4" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="3" lower_limit="3" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>144 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="6" lower_limit="6" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>196 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="4" lower_limit="4" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hours of Hospital Stay</title>
        <description>Each patient record the time of entry and measured the total hospital stay time in hours, recording the time of discharge to determine the total stay in hours. The hospital stay will be evaluated in hours. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.</description>
        <time_frame>Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.</time_frame>
        <population>All patients included in the study, underwent measurement of hours of hospital stay from admission to pediatric emergencies to hospital discharge.</population>
        <group_list>
          <group group_id="O1">
            <title>Hypertonic Saline Solution 3% (SHS 3%)</title>
            <description>We counted the hours from admission of the patient to the pediatric emergency department until hospital discharge. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.</description>
          </group>
          <group group_id="O2">
            <title>Saline Solution 0.9% (SS 0.9%) Group</title>
            <description>We counted the hours from admission of the patient to the pediatric emergency department until hospital discharge. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.</description>
          </group>
        </group_list>
        <measure>
          <title>Hours of Hospital Stay</title>
          <description>Each patient record the time of entry and measured the total hospital stay time in hours, recording the time of discharge to determine the total stay in hours. The hospital stay will be evaluated in hours. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.</description>
          <population>All patients included in the study, underwent measurement of hours of hospital stay from admission to pediatric emergencies to hospital discharge.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="5.4" upper_limit="9"/>
                    <measurement group_id="O2" value="39.3" lower_limit="23.9" upper_limit="61.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Readmission</title>
        <description>After the first admission of each patient will be evaluated during the next 30 days, if a patient is readmitted for any respiratory disease, respiratory distress, pneumonia or bronchiolitis. Considering as non-serious risks that do not compromise life, tachycardia, tremor, increased access to cough immediately to the inhalation, as well as the ardor of nasal mucosa, all these with limited characteristics, however, these do not put at risk The health of the patient, so they were not measured.</description>
        <time_frame>Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.</time_frame>
        <posting_date>05/2017</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Complications of the Disease Itself</title>
        <description>The presence or absence of clinical data to warrant dehydration of hydration, infected by bacteria, pneumothorax, interstitial emphysema and subcutaneous be evaluated.</description>
        <time_frame>Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.</time_frame>
        <posting_date>05/2017</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 month</time_frame>
      <desc>Since their admission to the trial, until a month after discharge.</desc>
      <group_list>
        <group group_id="E1">
          <title>Nebulized 0.9% Sodium Chloride</title>
          <description>Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.&#xD;
0.9% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.</description>
        </group>
        <group group_id="E2">
          <title>Nebulized 3% Sodium Chloride</title>
          <description>Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.&#xD;
3% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.</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="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </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="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>
    <point_of_contact>
      <name_or_title>Dr. Gloria Patricia Sosa-Bustamante</name_or_title>
      <organization>Instituto Mexicano del Seguro Social</organization>
      <phone>01 52 4777174800 ext 31828</phone>
      <email>patriciasosab@hotmail.com</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/NCT02233985
org study id: R-2012-1002-43
nct id: NCT02233985
lead sponsor: 
has dmc: Yes
- Determine the efficacy of nebulized salbutamol/hypertonic saline combination in moderate to
      severe bronchiolitis.
-  Study design: double-blind, randomized, parallel-controlled prospective study.

        -  Location: Department of pediatric emergencies and pediatric hospitalization of Highly
           Specialized Medical Unit (HSMU), Hospital of Gynecology-Obstetrics and Paediatrics
           (HGOP) No. 48, Mexican Institute of Social Security (MISS).

        -  Patients: 50 patients were included; 25 for each group. Patients had between 2 and 24
           months of age with a first episode of wheezing associated with respiratory distress and
           a history of infection of the upper respiratory tract, with moderate to severe degree of
           respiratory distress according to the Respiratory Distress Scale of Sant Joan de Déu
           Hospital (SJDH) .

        -  Interventions: the randomly allocated patients received in group I nebulised 0.9% saline
           with salbutamol 100 micrograms / kg / dose for 3 initial sessions lasting 20 minutes
           each and every 4 hours. In group II , hypertonic (3%) saline plus salbutamol 100
           micrograms / kg / dose for 3 initial sessions lasting 20 minutes each and every 4 hours.
           In both groups, will be performed at baseline Scale SJDH Respiratory Distress and the
           end of the first 3 sessions, you will have 30 minutes to make the second evaluation and
           at 4 hours the third at 8 hours and then every 24 hours throughout the hospital stay .
           The independent variable is the intervention with hypertonic saline 3% and the variable
           primary outcome will be assessed improvement or cure with Respiratory Distress Scale
           SJDH and secondary outcome will be the time of hospital stay .

        -  Descriptive statistics of all variables will be reported. T test was used for two
           independent groups or nonparametric test according to the distribution of the variables
           to compare the clinical improvement between the groups with the Scale of Respiratory
           Distress SJDH, as well as to determine whether there is a difference in time of hospital
           stay between the two study groups. Square test or Fisher exact chi used to compare
           readmissions for bronchial hyperresponsiveness between the two groups as well as the
           complications of the disease itself in each study group. Be reported with frequencies
           and percentages side effects of hypertonic saline 3%. Was considered statistically
           significant p <0.05. The results with the Number Cruncher Statistical System (NCSS) 2004
           statistical program will be discussed.

        -  The sample size was calculated with t-test to compare means of continuous variables,
           resulting in 25 subjects per group.

        -  In the follow-up period it was possible to obtain more patients from the baseline
           estimate of the sample number.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Score Respiratory Distress
time frame: Basal, 30 minutes after the end of the first 3 continuous nebulization sessions, at 4 hours, 8 hours and every 24 hours during the entire hospital stay
description: It is a validated clinical scale, sufficiently reliable measure of Severity of the respiratory distress. It consists of the summation score of the sibilance / crackling parameters (the largest of them), respiratory effort, pulmonary air inlet, oxygen saturation, heart rate and breathing rate. It is stratified into 3 levels of severity: mild from 0 to 5 points, moderate from 6 to 10 and severe from 10 to 16.
measure: Hours of Hospital Stay
time frame: Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.
description: Each patient record the time of entry and measured the total hospital stay time in hours, recording the time of discharge to determine the total stay in hours. The hospital stay will be evaluated in hours. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.
measure: Hospital Readmission
time frame: Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.
description: After the first admission of each patient will be evaluated during the next 30 days, if a patient is readmitted for any respiratory disease, respiratory distress, pneumonia or bronchiolitis. Considering as non-serious risks that do not compromise life, tachycardia, tremor, increased access to cough immediately to the inhalation, as well as the ardor of nasal mucosa, all these with limited characteristics, however, these do not put at risk The health of the patient, so they were not measured.
measure: Frequency of Complications of the Disease Itself
time frame: Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.
description: The presence or absence of clinical data to warrant dehydration of hydration, infected by bacteria, pneumothorax, interstitial emphysema and subcutaneous be evaluated.
arm group label: Nebulized 0.9% Sodium Chloride
arm group type: Active Comparator
description: Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
arm group label: Nebulized 3% Sodium Chloride
arm group type: Experimental
description: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
intervention type: Drug
intervention name: 0.9% Sodium Chloride
description: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
arm group label: Nebulized 0.9% Sodium Chloride
other name: 0.9% saline
intervention type: Drug
intervention name: 3% Sodium Chloride
description: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
arm group label: Nebulized 3% Sodium Chloride
other name: 3% saline
criteria: 
gender: All
minimum age: 2 Months
maximum age: 24 Months
healthy volunteers: No
last name: Gloria P Sosa-Bustamante, MD
role: Study Director
affiliation: Unidad Medica de Alta Especialidad Bajio 48. Hospital de Gineco - Pediatria. Instituto Mexicano del Seguro Social
facility: 
country: Mexico
url: http://www.nottingham.ac.uk/paediatric-guideline/breathingguideline.pdf
description: Guideline for the Management of Children Presenting With Acute Breathing Difficulty. Nottingham, United Kingdom: University of Nottingham
citation: Kuzik BA, Flavin MP, Kent S, Zielinski D, Kwan CW, Adeleye A, Vegsund BC, Rossi C. Effect of inhaled hypertonic saline on hospital admission rate in children with viral bronchiolitis: a randomized trial. CJEM. 2010 Nov;12(6):477-84. doi: 10.1017/s1481803500012690.
PMID: 21073773
citation: Sharma BS, Gupta MK, Rafik SP. Hypertonic (3%) saline vs 0.93% saline nebulization for acute viral bronchiolitis: a randomized controlled trial. Indian Pediatr. 2013 Aug;50(8):743-7. doi: 10.1007/s13312-013-0216-8. Epub 2012 Dec 5.
PMID: 23502662
citation: Gupta N, Puliyel A, Manchanda A, Puliyel J. Nebulized hypertonic-saline vs epinephrine for bronchiolitis; proof of concept study of cumulative sum (CUSUM) analysis. Indian Pediatr. 2012 Jul;49(7):543-7. doi: 10.1007/s13312-012-0122-5. Epub 2010 Oct 30.
PMID: 22080619
citation: Al-Ansari K, Sakran M, Davidson BL, El Sayyed R, Mahjoub H, Ibrahim K. Nebulized 5% or 3% hypertonic or 0.9% saline for treating acute bronchiolitis in infants. J Pediatr. 2010 Oct;157(4):630-4, 634.e1. doi: 10.1016/j.jpeds.2010.04.074. Epub 2010 Jun 19.
PMID: 20646715
citation: Luo Z, Fu Z, Liu E, Xu X, Fu X, Peng D, Liu Y, Li S, Zeng F, Yang X. Nebulized hypertonic saline treatment in hospitalized children with moderate to severe viral bronchiolitis. Clin Microbiol Infect. 2011 Dec;17(12):1829-33. doi: 10.1111/j.1469-0691.2010.03304.x. Epub 2010 Jul 15.
PMID: 20636429
citation: Grewal S, Ali S, McConnell DW, Vandermeer B, Klassen TP. A randomized trial of nebulized 3% hypertonic saline with epinephrine in the treatment of acute bronchiolitis in the emergency department. Arch Pediatr Adolesc Med. 2009 Nov;163(11):1007-12. doi: 10.1001/archpediatrics.2009.196.
PMID: 19884591
citation: Luo Z, Liu E, Luo J, Li S, Zeng F, Yang X, Fu Z. Nebulized hypertonic saline/salbutamol solution treatment in hospitalized children with mild to moderate bronchiolitis. Pediatr Int. 2010 Apr;52(2):199-202. doi: 10.1111/j.1442-200X.2009.02941.x. Epub 2009 Aug 7.
PMID: 19674354
citation: Postiaux G, Louis J, Labasse HC, Gerroldt J, Kotik AC, Lemuhot A, Patte C. Evaluation of an alternative chest physiotherapy method in infants with respiratory syncytial virus bronchiolitis. Respir Care. 2011 Jul;56(7):989-94. doi: 10.4187/respcare.00721. Epub 2011 Feb 22.
PMID: 21352671
responsible party type: Sponsor
mesh term: Bronchiolitis
mesh term: Respiratory Sounds
sharing ipd: Yes
ipd description: We have your membership number social security and personal data such as address and telephone number of the parents.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 