Comparative Analysis of Salivary and Bronchoalveolar Lavage IL-6 and TNF-α as Biomarkers in Pediatric Acute Respiratory Distress Syndrome

N/AEnrolling By InvitationNCT07380373

Ain Shams University37 enrolled

Overview

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.

• 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

Study Type

OBSERVATIONAL

Enrollment

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Interventions

BronchoscopyDIAGNOSTIC_TEST

Comparison between levels of inflammatory markers in both BAL \&salivary secretions

Eligibility

Sex: ALLMin age: 1 YearMax age: 10 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

Ain shams university, Cairo

Cairo, Egypt

Outcomes

Primary Outcomes

Agreement between BAL and salivary cytokine levels

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.

Time frame: Within 24 hours of ARDS diagnosis

Secondary Outcomes

Prediction of ARDS severity by cytokine levels

Ability of BAL and salivary cytokine levels to predict ARDS severity according to established criteria.

Time frame: First 48-72 hours

Association of cytokine levels with in-hospital mortality

Relationship between cytokine concentrations and all-cause in-hospital mortality.

Time frame: Through the study completion ( anaverage one year)

Association of cytokine levels with disease progression

Relationship between cytokine levels and worsening ARDS severity or escalation of respiratory support.

Time frame: Through the study completion of average one year

Association of cytokine levels with length of hospital stay

Relationship between cytokine concentrations and length of hospital stay.

Time frame: Through the study completion ( an average one year)

Comparative predictive performance of BAL versus salivary cytokines

Comparison of BAL and salivary cytokines in predicting ARDS severity, mortality, disease progression, and length of stay.

Time frame: Through a study completion of average one year

Data from ClinicalTrials.gov

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