Comparative Analysis of Salivary and Bronchoalveolar Lavage IL-6 and TNF-α as Biomazrkers in Pediatric Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Agreement between BAL and salivary cytokine levels
研究概览
简要总结
The aim of this study is to determine the degree of agreement in cytokines level measured through BAL and those measured through salivary glands excretion.
and to compare the validity of cytokines in BAL versus salivary secretion in predicting the stage of ARDS and disease outcome in term of mortality, disease progression and length of stay.
详细描述
• BAL will be performed by the attending pediatric intensivist in pediatric intensive care unit as part of standard care for ARDS management and Saliva samples will be collected non-invasively using sterile collection devices IL6 and TNF alfa will measured in both samples and compared to each other
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Pediatric Acute Respiratory Distress Syndrome (ARDS)
- •Age range: 1 month to 18 years
- •Requirement for invasive mechanical ventilation
- •Availability of salivary and bronchoalveolar lavage (BAL) samples within 24 hours of ARDS diagnosis
- •Informed consent obtained from parent or legal guardian
排除标准
- •Pre-existing chronic lung disease (e.g., cystic fibrosis, bronchopulmonary dysplasia)
- •Known immunodeficiency or current immunosuppressive therapy
- •Active malignancy or receipt of chemotherapy within the past 6 months
- •Severe congenital anomalies incompatible with survival
- •Refusal or inability to obtain informed consent
结局指标
主要结局
Agreement between BAL and salivary cytokine levels
时间窗: Within 24 hours of ARDS diagnosis
Degree of agreement between cytokine concentrations measured in bronchoalveolar lavage (BAL) fluid and salivary gland secretions collected simultaneously, assessed using intraclass correlation coefficients and Bland-Altman analysis.
次要结局
- Prediction of ARDS severity by cytokine levels(First 48-72 hours)
- Association of cytokine levels with in-hospital mortality(Through the study completion ( anaverage one year))
- Association of cytokine levels with disease progression(Through the study completion of average one year)
- Association of cytokine levels with length of hospital stay(Through the study completion ( an average one year))
- Comparative predictive performance of BAL versus salivary cytokines(Through a study completion of average one year)