Childhood PneumoniaNCT06951347
Prophylactic Sodium Supplementation for Children Hospitalized With Pneumonia
A study testing Oral Rehydration Solution in people with Childhood Pneumonia, run by General Organization for Teaching Hospitals and Institutes at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Childhood Pneumonia
- What is being tested?
- Oral Rehydration Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 5 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants and children aged between 1 month and 5 years.
- Patients diagnosed with pneumonia according to World Health Organization (WHO) criteria.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Childhood Pneumonia
- Being tested
- Oral Rehydration Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Rehydration SolutionDietary supplement
one sachet every day for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Dietary Supplement: Oral Rehydration Solution |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Children will be followed until discharge from the hospital, an average of one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 May 2025
- Primary completion1 Jun 2025
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Organization for Teaching Hospitals and Institutes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Taha, MD, General Organization for Teaching Hospitals and Institutes
- Investigators
- Marwa Taha, MD, Principal investigator, Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Cairo, EgyptHoda Atef Abdelsattar Ibrahim, MD, Principal investigator, Faculty of Medicine, Cairo University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951347
- Sponsor's protocol ID
- HM000174
- Status last verified
- Sep 2025
- First submitted
- 19 Apr 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prophylactic Sodium Supplementation on Hospital Outcomes in Infants and Children With Pneumonia. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06951347
- Acronym / sponsor ID
- HM000174
- Conditions
- Childhood Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- General Organization for Teaching Hospitals and InstitutesUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Oral Rehydration Solution |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants and children aged between 1 month and 5 years.
- Patients diagnosed with pneumonia according to World Health Organization (WHO) criteria.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Rehydration Solutionone sachet every day for 3 days | Dietary supplement | Intervention Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa Taha, MD principal investigator
Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Cairo, Egypt
Hoda Atef Abdelsattar Ibrahim, MD principal investigator
Faculty of Medicine, Cairo University, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Rehydration Solution in people with Childhood Pneumonia, run by General Organization for Teaching Hospitals and Institutes at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.