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/NCT06005454</url>
    </required_header>
    <id_info>
      <org_study_id>MS-369-2022</org_study_id>
      <nct_id>NCT06005454</nct_id>
    </id_info>
    <brief_title>The Impact of Fish Oil Supplementation on the Outcome of Children With Pneumonia i</brief_title>
    <official_title>The Impact of Fish Oil Supplementation on the Outcome of Children With Pneumonia in the Intensive Care Unit</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of study is to investigate the effect of enteral feeding of Omega-3 on the outcome of&#xD;
        children with Pneumonia in PICU&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Group A(cases) will be supplemented by omega-3 fatty acids for immediate post admission&#xD;
        consecutive 7 days besides conventional treatment of pneumonia, in a dose of 350 mg twice&#xD;
        daily for children less than 3 years and 450 mg twice daily for older children according to&#xD;
        the standard treatment per the American Institute of Medicine of the National Academies&#xD;
        guidelines for maximum dose for this age group. (Institute of Medicine of the National&#xD;
        Academies,2016)&#xD;
  &#xD;
        Side effects of omega-3 supplements are usually mild. They include unpleasant taste, bad&#xD;
        breath, bad-smelling sweat, headache, and gastrointestinal symptoms such as heartburn,&#xD;
        nausea, and diarrhea. (Office of Dietary Supplements ,2016)&#xD;
  &#xD;
        Group B(controls) will be received enteral feeding without omega-3 fatty acid support.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 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>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Randomized Controlled Trial</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Hospital length stay</measure>
      <time_frame>Through study completion, an average of 1 yea</time_frame>
      <description>Hospital length stay will be measured between the two groups</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">122</enrollment>
    <condition>Pneumonia</condition>
    <arm_group>
      <arm_group_label>Children with Pneumonia in intensive care unit receiving fish oil and the standard treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Children with Pneumonia in intensive care unit receiving the standard treatment only</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Fish oil (Omega)</intervention_name>
      <description>We will use a dietary supplement source of omega 3 fatty acids from the available syrup ( each 5 ml contain 640 mg of high DHA Fish oil) so we will give it in a dose 2.7 ml twice daily for children between 1 and 3 years and 3.5 ml twice daily for children between 4 and 5 years.</description>
      <arm_group_label>Children with Pneumonia in intensive care unit receiving fish oil and the standard treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria&#xD;
  &#xD;
            -  All children patients with severe pneumonia admitted to PICU&#xD;
  &#xD;
            -  Both sexes&#xD;
  &#xD;
            -  Age: under 5 years&#xD;
  &#xD;
            -  Whose parents or caregivers approve for participation in the study&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
            -  Patients with chronic illnesses to exclude bias that could be emerged due to the&#xD;
               chronic disease effect&#xD;
  &#xD;
            -  Whose parents or caregivers will not apply for participation in the study&#xD;
  &#xD;
            -  Patients who will be contraindicated for enteral feeding&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Month</minimum_age>
      <maximum_age>5 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Hoda Atef Abdelsattar Ibrahim</investigator_full_name>
      <investigator_title>Dr</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pneumonia</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/NCT06005454
  org study id: MS-369-2022
  nct id: NCT06005454
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of study is to investigate the effect of enteral feeding of Omega-3 on the outcome of
        children with Pneumonia in PICU
  Group A(cases) will be supplemented by omega-3 fatty acids for immediate post admission
        consecutive 7 days besides conventional treatment of pneumonia, in a dose of 350 mg twice
        daily for children less than 3 years and 450 mg twice daily for older children according to
        the standard treatment per the American Institute of Medicine of the National Academies
        guidelines for maximum dose for this age group. (Institute of Medicine of the National
        Academies,2016)
  
        Side effects of omega-3 supplements are usually mild. They include unpleasant taste, bad
        breath, bad-smelling sweat, headache, and gastrointestinal symptoms such as heartburn,
        nausea, and diarrhea. (Office of Dietary Supplements ,2016)
  
        Group B(controls) will be received enteral feeding without omega-3 fatty acid support.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized Controlled Trial
  primary purpose: Prevention
  masking: Single (Investigator)
  measure: Hospital length stay
  time frame: Through study completion, an average of 1 yea
  description: Hospital length stay will be measured between the two groups
  arm group label: Children with Pneumonia in intensive care unit receiving fish oil and the standard treatment
  arm group type: Experimental
  arm group label: Children with Pneumonia in intensive care unit receiving the standard treatment only
  arm group type: No Intervention
  intervention type: Dietary Supplement
  intervention name: Fish oil (Omega)
  description: We will use a dietary supplement source of omega 3 fatty acids from the available syrup ( each 5 ml contain 640 mg of high DHA Fish oil) so we will give it in a dose 2.7 ml twice daily for children between 1 and 3 years and 3.5 ml twice daily for children between 4 and 5 years.
  arm group label: Children with Pneumonia in intensive care unit receiving fish oil and the standard treatment
  criteria: 
  gender: All
  minimum age: 1 Month
  maximum age: 5 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Hoda Atef Abdelsattar Ibrahim
  investigator title: Dr
  mesh term: Pneumonia