Prophylactic Sodium Supplementation for Children Hospitalized With Pneumonia

September 17, 2025 updated by: Marwa Taha, MD, General Organization for Teaching Hospitals and Institutes

Impact of Prophylactic Sodium Supplementation on Hospital Outcomes in Infants and Children With Pneumonia. A Randomized Controlled Trial

The goal of this clinical trial is to study the impact of sodium supplementation on hospital outcomes of children with pneumonia.

It aims to answer:

  • Does sodium supplementation lower the length of hospital stay in children with pneumonia?
  • Does potassium supplementation lower the length of hospital stay in children with pneumonia?

Researchers will compare the intervention arm to the control arm to see if the intervention lowers the length of hospital stay.

Participants will:

• Take one sachet of oral rehydration solution (ORS) every day for 3 days.

Study Overview

Status

Completed

Conditions

Detailed Description

The study is a randomized clinical trial that will be conducted on hospitalized children with pneumonia after considering exclusion criteria.

The enrolled children will be randomly divided into two groups: the intervention group and the control group. The intervention group will receive the ORS daily for 3 days.

All children will be followed until discharge from the hospital, and their clinical outcomes will be assessed.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • Mataria Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Infants and children aged between 1 month and 5 years.
  • Patients diagnosed with pneumonia according to World Health Organization (WHO) criteria.

Exclusion Criteria:

  • Children with other comorbidities.
  • Those whose parents will show disapproval for the participation of the study.
  • Children on medications that affect sodium and potassium levels.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
one sachet every day for 3 days
No Intervention: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in hospital length of stay between hospitalized children with pneumonia who received oral rehydration solution and those who did not receive it
Time Frame: Children will be followed until discharge from the hospital, an average of one week.
Evaluation of effect of oral rehydration solution supplementation by assessing the length of hospital stay
Children will be followed until discharge from the hospital, an average of one week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marwa Taha, MD, Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Cairo, Egypt
  • Principal Investigator: Hoda Atef Abdelsattar Ibrahim, MD, Faculty of Medicine, Cairo University, Cairo, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

June 5, 2025

Study Registration Dates

First Submitted

April 19, 2025

First Submitted That Met QC Criteria

April 26, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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