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NCT Number: NCT07366593

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Down Syndrome with acute bronchopneumonia
  • sufficient cognitive ability

Exclusion criteria

  • severe congenital heart defects
  • primary immunodeficiencies

Treatment and study plan

Pearson or Spearman correlations were used to assess relationships between immune and respiratory variables, and with age

Procedure

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mona Mohamed Abdelkhalek, assistance prof

CONTACT

[email protected]

002021024056108

Mona Mohamed Abdelkhalek, assistance prof

CONTACT

[email protected]

002021024056108

Sponsors and collaborators

Lead sponsor

Badr University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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