NCT06951347

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

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

April 19, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2025

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

1 month

First QC Date

April 19, 2025

Last Update Submit

September 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The difference in hospital length of stay between hospitalized children with pneumonia who received oral rehydration solution and those who did not receive it

    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.

Study Arms (2)

Intervention Group

EXPERIMENTAL
Dietary Supplement: Oral Rehydration Solution

Control Group

NO INTERVENTION

Interventions

Oral Rehydration SolutionDIETARY_SUPPLEMENT

one sachet every day for 3 days

Intervention Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mataria Teaching Hospital

Cairo, Egypt

Location

MeSH Terms

Interventions

World Health Organization oral rehydration solution

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow of Pediatrics, Mataria Teaching Hospital (Principal Investigator)

Study Record Dates

First Submitted

April 19, 2025

First Posted

April 30, 2025

Study Start

May 1, 2025

Primary Completion

June 1, 2025

Study Completion

June 5, 2025

Last Updated

September 22, 2025

Record last verified: 2025-09

Locations