Clincosm LogoSign in Get a demo

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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06005454
Collaborator
(none)
122
Enrollment
2
Arms
5.9
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Fish oil (Omega)
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
122 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled TrialRandomized 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
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

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

Primary Outcome Measures

  1. Hospital length stay [Through study completion, an average of 1 yea]

    Hospital length stay will be measured between the two groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoda Atef Abdelsattar Ibrahim, Dr, Cairo University
ClinicalTrials.gov Identifier:
NCT06005454
Other Study ID Numbers:
  • MS-369-2022
First Posted:
Aug 22, 2023
Last Update Posted:
Aug 22, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pneumonia

Study Results

No Results Posted as of Aug 22, 2023