ARDS (Acute Respiratory Distress Syndrome)NCT07380373
Comparative Analysis of Salivary and Bronchoalveolar Lavage IL-6 and TNF-α as Biomarkers in Pediatric Acute Respiratory Distress Syndrome
An observational study of ARDS (Acute Respiratory Distress Syndrome), run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- What is being tested?
- Bronchoscopy
- How many people
- 37 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 1 Jun 2026
- How long will I take part?
- 5 Days
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Analysis of Salivary and Bronchoalveolar Lavage IL-6 and TNF-α as Biomazrkers 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.
Read the detailed description
- 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
- Being tested
- Bronchoscopy
- Keywords
- ARDS, Salivary biomarkers, IL-6, TNF alfa, BAL biomarkers
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyDiagnostic test
Comparison between levels of inflammatory markers in both BAL \&salivary secretions
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours of ARDS diagnosis
Secondary outcomes (5)
Prediction of ARDS severity by cytokine levels
Ability of BAL and salivary cytokine levels to predict ARDS severity according to established criteria.
Measured: First 48-72 hours
Association of cytokine levels with in-hospital mortality
Relationship between cytokine concentrations and all-cause in-hospital mortality.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through a study completion of average one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 May 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 37 participants (estimated)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Tarekahmed Abdelgawad, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380373
- Sponsor's protocol ID
- MD88/2025
- Status last verified
- Apr 2025
- First submitted
- 20 Dec 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared outside the primary research team