HypoalbuminemiaNCT05050851
Nutritional Parameters and Other Risk Factors Affecting Severity of Pneumonia in Children Under Five Years in Upper Egypt
An observational study of Hypoalbuminemia and Stunted Growth, run by Assiut University.
Trial summary
Decrease mortality rate resulting from pneumonia Read more about this study
- Who is it for?
- Ages 1 month to 60 months
- Conditions the study is for
- Hypoalbuminemia, Stunted Growth, Anemia, Iron Deficiency
- What is being tested?
- Measurement of nutritional parameters in children with pneumonia
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2021to 30 Oct 2022
- Phase
- Observational
- 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 60 months
- All sexes
- No healthy volunteers
- Child
Study population: children admitted at Assiut university children hospital below five years with diagnosis of pneumonia on admission.
Who may be able to join
- Diagnosis of pneumonia on day 1 of hospital admission.
Who cannot join
- patients with cardiac diseases
- patients with immune deficiency disorders
About this study
Decrease mortality rate resulting from pneumonia
Read the detailed description
Recruiting patients with pneumonia admitted at Assiut University hospital . Then assessment of their condition and severity of pneumonia by examination and X-ray chest . After that, we aim at assessment their nutrition status and it's effect on severity of pneumonia. So we aim to investigate them by CBC, Albumin, CRP and CXR and correlate these parameters with the severity of pneumonia to assess the impact of nutrition on outcome of chest infections
- Conditions
- Hypoalbuminemia, Stunted Growth, Anemia, Iron Deficiency
- Being tested
- Measurement of nutritional parameters in children with pneumonia
- Keywords
- Pneumonia, nutrition, blood tests, body mass index
- Medical subject headings
- Hypoalbuminemia, Growth Disorders, Anemia, Iron-Deficiency, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of nutritional parameters in children with pneumoniaDietary supplement
measurement of Body Mass Index, head circumference, weight, length
What is being measured
The primary outcome is the main question the study is designed to answer.
ratio of body mass index in patients with pneumonia
we calculate height of patients in metres and weight in Kg then we divide the weight over the height square to get the body mass index
Measured: Day 1 assessment on hospital admission
Secondary outcomes (2)
Concentration of Albumin in patients with pneumonia in g/dl
blood samlpe will be taken for measuring Albumin level
Measured: Day 1 assessment on hospital admission
Hemoglobin level in patients with pnemonia in g/dl
blood samlpe will be taken for measuring hemoglobin level
Measured: Day 1 assessment on hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start30 Sep 2021 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoalbuminemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Omar Mahmoud Said, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050851
- Sponsor's protocol ID
- AOMSaid
- Status last verified
- Sep 2021
- First submitted
- 21 Sep 2020
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifiable data will be available to others apart from me as data collector
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Parameters and Other Risk Factors Affecting Severity of Pneumonia in Children Under Five Years in Upper Egypt
- ClinicalTrials.gov ID
- NCT05050851
- Acronym / sponsor ID
- AOMSaid
- Conditions
- Hypoalbuminemia, Stunted Growth, Anemia, Iron Deficiency
- Keywords
- Pneumonia, nutrition, blood tests, body mass index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Sep 2021 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 21 Sep 2021 (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.
Decrease mortality rate resulting from pneumonia
Detailed description
Recruiting patients with pneumonia admitted at Assiut University hospital . Then assessment of their condition and severity of pneumonia by examination and X-ray chest . After that, we aim at assessment their nutrition status and it's effect on severity of pneumonia. So we aim to investigate them by CBC, Albumin, CRP and CXR and correlate these parameters with the severity of pneumonia to assess the impact of nutrition on outcome of chest infections
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children admitted at Assiut university children hospital below five years with diagnosis of pneumonia on admission.
Key inclusion criteria (1 listed)
- Diagnosis of pneumonia on day 1 of hospital admission.
Key exclusion criteria (2 listed)
- patients with cardiac diseases
- patients with immune deficiency disorders
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 |
|---|---|---|
| Measurement of nutritional parameters in children with pneumoniameasurement of Body Mass Index, head circumference, weight, length | Dietary supplement | – |
Primary outcome
ratio of body mass index in patients with pneumonia
Time frame: Day 1 assessment on hospital admission
we calculate height of patients in metres and weight in Kg then we divide the weight over the height square to get the body mass index
2 secondary outcomes
Concentration of Albumin in patients with pneumonia in g/dl
Time frame: Day 1 assessment on hospital admission
Hemoglobin level in patients with pnemonia in g/dl
Time frame: Day 1 assessment on hospital admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Individual participant dataSharing planned: No. No identifiable data will be available to others apart from me as data collector
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoalbuminemia and Stunted Growth, run by Assiut University.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
ratio of body mass index in patients with pneumonia (time frame: Day 1 assessment on hospital admission). 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 21 Sep 2021.