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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Salivary and Bronchoalveolar Lavage IL-6 and TNF-α as Biomazrkers in Pediatric Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07380373
- Acronym / sponsor ID
- MD88/2025
- Keywords
- ARDS, Salivary biomarkers, IL-6, TNF alfa, BAL biomarkers
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Days
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BronchoscopyComparison between levels of inflammatory markers in both BAL \&salivary secretions | Diagnostic test | – |
Primary outcome
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.
5 secondary outcomes
Prediction of ARDS severity by cytokine levels
Time frame: First 48-72 hours
Association of cytokine levels with in-hospital mortality
Time frame: Through the study completion ( anaverage one year)
Association of cytokine levels with disease progression
Time frame: Through the study completion of average one year
Association of cytokine levels with length of hospital stay
Time frame: Through the study completion ( an average one year)
Comparative predictive performance of BAL versus salivary cytokines
Time frame: Through a study completion of average one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared outside the primary research team
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Tarekahmed Abdelgawad study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS (Acute Respiratory Distress Syndrome), run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between BAL and salivary cytokine levels (time frame: Within 24 hours of ARDS diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.