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The Impact of Fish Oil Supplementation on the Outcome of Children With Pneumonia i

Primary Purpose

Pneumonia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fish oil (Omega)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumonia

Eligibility Criteria

1 Month - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria All children patients with severe pneumonia admitted to PICU Both sexes Age: under 5 years Whose parents or caregivers approve for participation in the study Exclusion Criteria Patients with chronic illnesses to exclude bias that could be emerged due to the chronic disease effect Whose parents or caregivers will not apply for participation in the study Patients who will be contraindicated for enteral feeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Children with Pneumonia in intensive care unit receiving fish oil and the standard treatment

    Children with Pneumonia in intensive care unit receiving the standard treatment only

    Arm Description

    Outcomes

    Primary Outcome Measures

    Hospital length stay
    Hospital length stay will be measured between the two groups

    Secondary Outcome Measures

    Full Information

    First Posted
    August 10, 2023
    Last Updated
    August 17, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06005454
    Brief Title
    The Impact of Fish Oil Supplementation on the Outcome of Children With Pneumonia i
    Official Title
    The Impact of Fish Oil Supplementation on the Outcome of Children With Pneumonia in the Intensive Care Unit
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    February 1, 2024 (Anticipated)
    Study Completion Date
    February 28, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of study is to investigate the effect of enteral feeding of Omega-3 on the outcome of children with Pneumonia in PICU
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumonia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized Controlled Trial
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    122 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Children with Pneumonia in intensive care unit receiving fish oil and the standard treatment
    Arm Type
    Experimental
    Arm Title
    Children with Pneumonia in intensive care unit receiving the standard treatment only
    Arm Type
    No Intervention
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Fish oil (Omega)
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Hospital length stay
    Description
    Hospital length stay will be measured between the two groups
    Time Frame
    Through study completion, an average of 1 yea

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria All children patients with severe pneumonia admitted to PICU Both sexes Age: under 5 years Whose parents or caregivers approve for participation in the study Exclusion Criteria Patients with chronic illnesses to exclude bias that could be emerged due to the chronic disease effect Whose parents or caregivers will not apply for participation in the study Patients who will be contraindicated for enteral feeding

    12. IPD Sharing Statement

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