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

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ClinicalTrials.gov Identifier: NCT06005454
Recruitment Status : Recruiting
First Posted : August 22, 2023
Last Update Posted : February 9, 2024
Sponsor:
Information provided by (Responsible Party):
Hoda Atef Abdelsattar Ibrahim, Cairo University

Study Description
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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

Condition or disease Intervention/treatment Phase
Pneumonia Dietary Supplement: Fish oil (Omega) Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The Impact of Fish Oil Supplementation on the Outcome of Children With Pneumonia in the Intensive Care Unit
Actual Study Start Date : September 1, 2023
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : May 28, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
Drug Information available for: Fish oil

Arms and Interventions
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Arm Intervention/treatment
Experimental: Children with Pneumonia in intensive care unit receiving fish oil and the standard treatment Dietary Supplement: Fish oil (Omega)
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.
No Intervention: Children with Pneumonia in intensive care unit receiving the standard treatment only


Outcome Measures
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Primary Outcome Measures :
  1. Hospital length stay [ Time Frame: Through study completion, an average of 1 yea ]
    Hospital length stay will be measured between the two groups


Eligibility Criteria
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Ages Eligible for Study:   1 Month to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06005454


Contacts
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Contact: Hoda Atef Abelsattar Ibrahim 01116344417 hodaibrahim424@gmail.com

Locations
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Egypt
Hoda Atef Abdelsattar Ibrahim Recruiting
Cairo, Egypt
Contact: Hoda Atef Abdelsattar Ibrahim       hodaibrahim424@gmail.com   
Sponsors and Collaborators
Cairo University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Hoda Atef Abdelsattar Ibrahim, Dr, Cairo University
ClinicalTrials.gov Identifier: NCT06005454    
Other Study ID Numbers: MS-369-2022
First Posted: August 22, 2023    Key Record Dates
Last Update Posted: February 9, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases