<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/NCT02245139</url>
  </required_header>
  <id_info>
    <org_study_id>SRHH12014</org_study_id>
    <nct_id>NCT02245139</nct_id>
  </id_info>
  <brief_title>Surveillance Study of Acute Gastroenteritis in Hospitalized Children</brief_title>
  <acronym>SAGE</acronym>
  <official_title>Surveillance Study of Acute Gastroenteritis Etiologies in Hospitalized Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shaikh Ragheb Harb Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shaikh Ragheb Harb Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute gastroenteritis is a common cause of hospital admission and health office visits and&#xD;
      have a huge burden on the economy of developing countries. The investigators proposed this&#xD;
      observational prospective study during summer period in a community and tertiary care&#xD;
      hospital in a rural area of Lebanon to investigate the etiologies and age distribution of&#xD;
      admitted cases to general pediatric floor from the age of 1 month up to the age of 14 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2014</start_date>
  <completion_date type="Actual">December 15, 2014</completion_date>
  <primary_completion_date type="Actual">September 15, 2014</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>7 Days</target_duration>
  <primary_outcome>
    <measure>etiologies</measure>
    <time_frame>1 year</time_frame>
    <description>to determine the microbial causes of acute gastroenteritis</description>
  </primary_outcome>
  <enrollment type="Actual">198</enrollment>
  <condition>Acute Gastroenteritis</condition>
  <condition>Diarrhea</condition>
  <condition>Dehydration</condition>
  <eligibility>
    <study_pop>
      <textblock>
        male and female patient from 1 month to 13 YO admitted to pediatric floor with acute&#xD;
        gastroenteritis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  acute gastroenteritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  immunodeficiency&#xD;
&#xD;
          -  malnutrition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>April 26, 2017</last_update_submitted>
  <last_update_submitted_qc>April 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shaikh Ragheb Harb Hospital</investigator_affiliation>
    <investigator_full_name>HADI FAKIH, MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>diarrhea</keyword>
  <keyword>vomiting</keyword>
  <keyword>fever</keyword>
  <keyword>abdominal pain</keyword>
  <keyword>oliguria</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroenteritis</mesh_term>
    <mesh_term>Dehydration</mesh_term>
    <mesh_term>Diarrhea</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/NCT02245139
org study id: SRHH12014
nct id: NCT02245139
lead sponsor: 
has dmc: No
Acute gastroenteritis is a common cause of hospital admission and health office visits and
      have a huge burden on the economy of developing countries. The investigators proposed this
      observational prospective study during summer period in a community and tertiary care
      hospital in a rural area of Lebanon to investigate the etiologies and age distribution of
      admitted cases to general pediatric floor from the age of 1 month up to the age of 14 years.
observational model: Case-Only
time perspective: Prospective
measure: etiologies
time frame: 1 year
description: to determine the microbial causes of acute gastroenteritis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 13 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Shaikh Ragheb Harb Hospital
investigator full name: HADI FAKIH, MD
investigator title: MD
mesh term: Gastroenteritis
mesh term: Dehydration
mesh term: Diarrhea