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临床试验/NCT07366593
NCT07366593招募中不适用

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

Badr University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
serum IgG, IgA, IgM

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
1 Year 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Down Syndrome with acute bronchopneumonia
  • sufficient cognitive ability

排除标准

  • severe congenital heart defects
  • primary immunodeficiencies

结局指标

主要结局

serum IgG, IgA, IgM

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Badr University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mona Mohamed Abdelkhalek

assistance professor

Badr University

研究点 (2)

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