Down SyndromeNCT07366593
Immune Profile and Respiratory Parameters in Down Syndrome Children With Acute Pneumonia: Pre-Intervention Analysis
An observational study of Down Syndrome, run by Badr University at 2 sites in Egypt.
Trial summary
Baseline serum IgG, IgA, IgM (nephelometry), total WBC count (automated analyzer), RR (manual count), and SaO2 (pulse oximetry) were measured. Pearson or Spearman correlations were used to assess relationships between immune and respiratory variables, and with age Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Pearson or Spearman correlations were used to assess relationships between immune and respiratory variables, and with age
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jul 2025to 30 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 year to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Data collection occurred at the inpatient pediatric ward of King Abdulaziz University Hospital.
Who may be able to join
- Down Syndrome with acute bronchopneumonia
- sufficient cognitive ability
Who cannot join
- severe congenital heart defects
- primary immunodeficiencies
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Badr university
Cairo
Mona Abdelkhalek, Phd
- Recruiting
Mona Mohamed Abdelkhalek
Cairo
Mona Abdelkhalek, assistance prof, 002021024056108, 3m.sons@gmail.com
About this study
Official title: Relationship Between Immune Profile and Respiratory Parameters in Down Syndrome Children With Acute Pneumonia: Pre-Intervention Analysis
Baseline serum IgG, IgA, IgM (nephelometry), total WBC count (automated analyzer), RR (manual count), and SaO2 (pulse oximetry) were measured. Pearson or Spearman correlations were used to assess relationships between immune and respiratory variables, and with age
Read the detailed description
descriptive, cross-sectional study analyzed baseline data from 40 children with DS and acute pneumonia enrolled prior to intervention in a larger trial. Baseline serum IgG, IgA, IgM (nephelometry), total WBC count (automated analyzer), RR (manual count), and SaO2 (pulse oximetry) were measured. Pearson or Spearman correlations were used to assess relationships between immune and respiratory variables, and with age.
- Conditions
- Down Syndrome
- Being tested
- Pearson or Spearman correlations were used to assess relationships between immune and respiratory variables, and with age
- Keywords
- Down Syndrome, pneumonia, immune, oxygen saturation
- Medical subject headings
- Down Syndrome, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pearson or Spearman correlations were used to assess relationships between immune and respiratory variables, and with ageProcedure or surgery
Baseline serum IgG, IgA, IgM (nephelometry), total WBC count (automated analyzer), RR (manual count), and SaO2 (pulse oximetry) were measured. Pearson or Spearman correlations were used to assess relationships between immune and respiratory variables, and with age.
What is being measured
The primary outcome is the main question the study is designed to answer.
serum IgG, IgA, IgM
Immunoglobulins: Concentrations of IgG(mg/dl) IgA,(mg/dl) and IgM (mg/dl) were determined from serum using an automated nephelometer
Measured: Upon enrollment and prior to any intervention baseline data were collected
Respiratory Rate
Respiratory rate (breaths/minute) was determined by direct observation and counting of chest wall movements over one full minute
Measured: Upon enrollment and prior to any intervention baseline data were collected
Arterial Oxygen Saturation (SaO2)
Peripheral oxygen saturation (%) was measured non-invasively via pulse oximetry
Measured: Upon enrollment and prior to any intervention baseline data were collected
White Blood Cell count
Total WBC count (thousands/mm³) was measured from a whole blood sample using an ADVIA 120 automated hematology analyzer
Measured: Upon enrollment and prior to any intervention baseline data were collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Jul 2025
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohamed Abdelkhalek, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366593
- Sponsor's protocol ID
- Down Syndrome Children
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators have not yet determined whether individual participant data will be shared. Any future decision will depend on institutional policies, ethical considerations, and applicable data protection regulations."
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Immune Profile and Respiratory Parameters in Down Syndrome Children With Acute Pneumonia: Pre-Intervention Analysis
- ClinicalTrials.gov ID
- NCT07366593
- Acronym / sponsor ID
- Down Syndrome Children
- Conditions
- Down Syndrome
- Keywords
- Down Syndrome, pneumonia, immune, oxygen saturation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 26 Jan 2026 (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.
Baseline serum IgG, IgA, IgM (nephelometry), total WBC count (automated analyzer), RR (manual count), and SaO2 (pulse oximetry) were measured. Pearson or Spearman correlations were used to assess relationships between immune and respiratory variables, and with age
Detailed description
descriptive, cross-sectional study analyzed baseline data from 40 children with DS and acute pneumonia enrolled prior to intervention in a larger trial. Baseline serum IgG, IgA, IgM (nephelometry), total WBC count (automated analyzer), RR (manual count), and SaO2 (pulse oximetry) were measured. Pearson or Spearman correlations were used to assess relationships between immune and respiratory variables, and with age.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Data collection occurred at the inpatient pediatric ward of King Abdulaziz University Hospital.
Key inclusion criteria (2 listed)
- Down Syndrome with acute bronchopneumonia
- sufficient cognitive ability
Key exclusion criteria (2 listed)
- severe congenital heart defects
- primary immunodeficiencies
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 |
|---|---|---|
| Pearson or Spearman correlations were used to assess relationships between immune and respiratory variables, and with ageBaseline serum IgG, IgA, IgM (nephelometry), total WBC count (automated analyzer), RR (manual count), and SaO2 (pulse oximetry) were measured. Pearson or Spearman correlations were used to assess relationships between immune and respiratory variables, and with age. | Procedure or surgery | – |
Primary outcome
serum IgG, IgA, IgM
Time frame: Upon enrollment and prior to any intervention baseline data were collected
Immunoglobulins: Concentrations of IgG(mg/dl) IgA,(mg/dl) and IgM (mg/dl) were determined from serum using an automated nephelometer
Respiratory Rate
Time frame: Upon enrollment and prior to any intervention baseline data were collected
Respiratory rate (breaths/minute) was determined by direct observation and counting of chest wall movements over one full minute
Arterial Oxygen Saturation (SaO2)
Time frame: Upon enrollment and prior to any intervention baseline data were collected
Peripheral oxygen saturation (%) was measured non-invasively via pulse oximetry
White Blood Cell count
Time frame: Upon enrollment and prior to any intervention baseline data were collected
Total WBC count (thousands/mm³) was measured from a whole blood sample using an ADVIA 120 automated hematology analyzer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: Undecided. The investigators have not yet determined whether individual participant data will be shared. Any future decision will depend on institutional policies, ethical considerations, and applicable data protection regulations."
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Down Syndrome
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome, run by Badr University at 2 sites 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 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: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mona Mohamed Abdelkhalek, assistance prof (002021024056108, 3m.sons@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum IgG, IgA, IgM (time frame: Upon enrollment and prior to any intervention baseline data were collected). The study lists 4 primary outcomes in all. 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 26 Jan 2026.