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NCT06005454 Clinical Trial

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

Pneumonia Clinical Trial

Official title:
The Impact of Fish Oil Supplementation on the Outcome of Children With Pneumonia in the Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06005454
Other study ID # MS-369-2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date June 11, 2024

Study information
Verified date June 2024
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 122
Est. completion date June 11, 2024
Est. primary completion date June 11, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month to 5 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Egypt Hoda Atef Abdelsattar Ibrahim Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hospital length stay Hospital length stay will be measured between the two groups Through study completion, an average of 1 yea
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