xml: <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/NCT06038305</url>
    </required_header>
    <id_info>
      <org_study_id>anemia and growth in AGE</org_study_id>
      <nct_id>NCT06038305</nct_id>
    </id_info>
    <brief_title>Prevalence of Anemia and Growth Assessment in Acute Gastroenteritis</brief_title>
    <official_title>Prevalence of Anemia and Growth Assessment of Infants Admitted With Acute Gastroenteritis in Assiut University Children Hospital</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        1. Assessment of the growth parameters in infants admitted with acute gastroenteritis.&#xD;
  &#xD;
          2. Determine the prevalence of anemia in infants admitted with acute gastroenteritis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Gastroenteritis is inflammation of the stomach, small intestine, or large intestine, leading&#xD;
        to a combination of abdominal pain, cramping, nausea, vomiting, and diarrhea. Acute&#xD;
        gastroenteritis usually lasts fewer than 14 days. Worldwide, gastroenteritis affects 3 to 5&#xD;
        billion children each year. Up to 40% of children aged less than 5 years with diarrhea are&#xD;
        hospitalized with rotavirus. Also, some microorganisms have been found predominantly in&#xD;
        resource-constrained nations, including Shigella spp, Vibrio cholerae, and the protozoan&#xD;
        infections. Malnutrition, immunosuppression, young age, and an increase in the preceding&#xD;
        diarrhea burdens are risk factors for the development of persistent diarrhea. A substantial&#xD;
        proportion of global malnutrition is due to impaired intestinal absorptive function resulting&#xD;
        from multiple and repeated enteric infections. These include recurrent acute infections as&#xD;
        well as persistent infections, even those without overt liquid diarrhea.&#xD;
  &#xD;
        Child growth is internationally recognized as the best global indicator of physical&#xD;
        well-being in children because poor feeding practices-both in quantity and quality-and&#xD;
        infections, or more often a combination of the two, are major factors that affect physical&#xD;
        growth and mental development in children. The most important measurements needed for growth&#xD;
        assessment are recumbent length or height, weight and head circumference. These fundamental&#xD;
        anthropometric measures should be obtained and interpreted at each well child visit, and are&#xD;
        typically sufficient for growth assessment.&#xD;
  &#xD;
        In this study, the prevalence of anemia and growth of infants admitted with acute&#xD;
        gastroenteritis at Assiut University Children Hospital will be assessed. Anemia is a global&#xD;
        public health problem, with important consequences for human health and the social and&#xD;
        economic development of each nation. It results from single or multiple causes that act&#xD;
        simultaneously, influencing children's health, their cognitive and physical development, and&#xD;
        immunity, increasing the risk of infections and infant mortality.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">February 2025</completion_date>
    <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Determine association between anemia and acute gastroenteritis in infants and children.</measure>
      <time_frame>baseline</time_frame>
      <description>assess anemia in children with acute gastroenteritis and if anemia affect severity of acute gastroenteritis</description>
    </primary_outcome>
    <enrollment type="Anticipated">297</enrollment>
    <condition>Acute Gastroenteritis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          infants aged 1 month up to 2 years with acute gastroenteritis&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Infants with acute gastroenteritis.&#xD;
  &#xD;
            -  Infants aged from 1 month and up to 2 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Infants aged less than 1 month and more than 2 years.&#xD;
  &#xD;
            -  Infants with persistent and chronic diarrhea.&#xD;
  &#xD;
            -  Infants with acute gastroenteritis in association with chronic disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Month</minimum_age>
      <maximum_age>2 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Gehad Ali</last_name>
      <phone>01011001797</phone>
      <email>gehadali4397@gmail.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Gehad Ali Sayed</investigator_full_name>
      <investigator_title>Resident physician, Family Medicine department</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gastroenteritis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038305
  org study id: anemia and growth in AGE
  nct id: NCT06038305
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  1. Assessment of the growth parameters in infants admitted with acute gastroenteritis.
  
          2. Determine the prevalence of anemia in infants admitted with acute gastroenteritis.
  Gastroenteritis is inflammation of the stomach, small intestine, or large intestine, leading
        to a combination of abdominal pain, cramping, nausea, vomiting, and diarrhea. Acute
        gastroenteritis usually lasts fewer than 14 days. Worldwide, gastroenteritis affects 3 to 5
        billion children each year. Up to 40% of children aged less than 5 years with diarrhea are
        hospitalized with rotavirus. Also, some microorganisms have been found predominantly in
        resource-constrained nations, including Shigella spp, Vibrio cholerae, and the protozoan
        infections. Malnutrition, immunosuppression, young age, and an increase in the preceding
        diarrhea burdens are risk factors for the development of persistent diarrhea. A substantial
        proportion of global malnutrition is due to impaired intestinal absorptive function resulting
        from multiple and repeated enteric infections. These include recurrent acute infections as
        well as persistent infections, even those without overt liquid diarrhea.
  
        Child growth is internationally recognized as the best global indicator of physical
        well-being in children because poor feeding practices-both in quantity and quality-and
        infections, or more often a combination of the two, are major factors that affect physical
        growth and mental development in children. The most important measurements needed for growth
        assessment are recumbent length or height, weight and head circumference. These fundamental
        anthropometric measures should be obtained and interpreted at each well child visit, and are
        typically sufficient for growth assessment.
  
        In this study, the prevalence of anemia and growth of infants admitted with acute
        gastroenteritis at Assiut University Children Hospital will be assessed. Anemia is a global
        public health problem, with important consequences for human health and the social and
        economic development of each nation. It results from single or multiple causes that act
        simultaneously, influencing children's health, their cognitive and physical development, and
        immunity, increasing the risk of infections and infant mortality.
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: Determine association between anemia and acute gastroenteritis in infants and children.
  time frame: baseline
  description: assess anemia in children with acute gastroenteritis and if anemia affect severity of acute gastroenteritis
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Month
  maximum age: 2 Years
  last name: Gehad Ali
  phone: 01011001797
  email: gehadali4397@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Gehad Ali Sayed
  investigator title: Resident physician, Family Medicine department
  mesh term: Gastroenteritis