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Enrolling by Invitation

NCT Number: NCT07380373

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

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.

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Key information

Conditions

ARDS (Acute Respiratory Distress Syndrome) Acute Lung Injury Lung Diseases Lung Injury Respiratory Tract Diseases

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain shams university, Cairo

Cairo, 11517, Egypt

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bronchoscopy

Diagnostic Test

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

Primary outcomes

  1. Agreement between BAL and salivary cytokine levels

    Time frame: 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.

Secondary outcomes

  1. Prediction of ARDS severity by cytokine levels

    Time frame: First 48-72 hours

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

  2. Association of cytokine levels with in-hospital mortality

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

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

  3. Association of cytokine levels with disease progression

    Time frame: Through the study completion of average one year

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

  4. Association of cytokine levels with length of hospital stay

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

    Relationship between cytokine concentrations and length of hospital stay.

  5. Comparative predictive performance of BAL versus salivary cytokines

    Time frame: Through a study completion of average one year

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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