NCT06005454

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2024

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

August 10, 2023

Last Update Submit

March 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hospital length stay

    Hospital length stay will be measured between the two groups

    Through study completion, an average of 1 yea

Study Arms (2)

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

EXPERIMENTAL
Dietary Supplement: Fish oil (Omega)

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

NO INTERVENTION

Interventions

Fish oil (Omega)DIETARY_SUPPLEMENT

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.

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

Eligibility Criteria

Age1 Month - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hoda Atef Abdelsattar Ibrahim

Cairo, Egypt

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

OilsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 10, 2023

First Posted

August 22, 2023

Study Start

September 1, 2023

Primary Completion

September 11, 2024

Study Completion

October 11, 2024

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations