Immune Profile and Respiratory Parameters in Down Syndrome Children With Acute Pneumonia: Pre-Intervention Analysis

January 16, 2026 updated by: Mona Mohamed Abdelkhalek, Badr University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mona Mohamed Abdelkhalek, assistance prof
  • Phone Number: 002021024056108
  • Email: 3m.sons@gmail.com

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Badr University
        • Contact:
          • Mona Abdelkhalek, Phd
      • Cairo, Egypt
        • Recruiting
        • Mona Mohamed Abdelkhalek
        • Contact:
          • Mona Abdelkhalek, assistance prof
          • Phone Number: 002021024056108
          • Email: 3m.sons@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Data collection occurred at the inpatient pediatric ward of King Abdulaziz University Hospital.

Description

Inclusion Criteria:

  • Down Syndrome with acute bronchopneumonia
  • sufficient cognitive ability

Exclusion Criteria:

  • severe congenital heart defects
  • primary immunodeficiencies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Upon enrollment and prior to any intervention baseline data were collected
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
Upon enrollment and prior to any intervention baseline data were collected
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
Upon enrollment and prior to any intervention baseline data were collected
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
Upon enrollment and prior to any intervention baseline data were collected

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Badr University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

January 30, 2026

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Down Syndrome Children

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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."

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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