- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06951347
Prophylactic Sodium Supplementation for Children Hospitalized With Pneumonia
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Mataria Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
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
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM000174
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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