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

NCT07380373 | Enrolling By Invitation DMC

• 1 other identifier: MD88/2025
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Keywords

ARDS; Salivary biomarkers; IL-6; TNF alfa; BAL biomarkers

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 24 hours of ARDS diagnosis

Secondary Outcomes (5)

• 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

Interventions

Bronchoscopy DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of pediatric patients diagnosed with mild to moderate acute respiratory distress syndrome (ARDS) who are admitted to the pediatric intensive care unit (PICU) and on mechanical ventilation to decrease the hazards of bronchoscopy on sever patients with ARDS

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university, Cairo

Cairo, 11517, Egypt

Location

MeSH Terms

Conditions

Acute Lung Injury

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Dr. Tarekahmed Abdelgawad

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: February 2, 2026
• Study Start: May 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)