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

NCT07366593 | Recruiting

• 1 other identifier: Down Syndrome Children
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Down Syndrome

Keywords

Down Syndrome, pneumonia, immune, oxygen saturation

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  Upon enrollment and prior to any intervention baseline data were collected

Interventions

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.

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Down Syndrome with acute bronchopneumonia
• sufficient cognitive ability

You may not qualify if:

• severe congenital heart defects
• primary immunodeficiencies

Sponsors & Collaborators

• Badr University: lead

Study Sites (2)

Badr university

Cairo, Egypt

RECRUITING

Mona Mohamed Abdelkhalek

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Down Syndrome; Pneumonia

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Mona Mohamed Abdelkhalek, assistance prof

CONTACT

002021024056108; 3m.sons@gmail.com

Mona Mohamed Abdelkhalek, assistance prof

CONTACT

002021024056108; Mona.Abdelkhalek@buc.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistance professor

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 26, 2026
• Study Start: July 1, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

EG (2)