Acute Respiratory Distress Syndrome (ARDS)NCT07414056
Turning Ratios Into Prognosis: Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Powerful Predictors of ARDS in Pediatric Burn Patients: A Prospective Evaluation
An observational study of Acute Respiratory Distress Syndrome (ARDS), run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the role of Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as predictors for development of ARDS in pediatric burn patients. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2025to 10 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 years
- All sexes
- No healthy volunteers
- Child
Study population: A prospective observational cohort study will be performed in our burn ICU at Ain Shams University Hospitals. Ethical clearance will be taken from the institutional ethics committee. Written informed consent will be obtained from the patients/authorized representatives of the patients. All eligible pediatric patients with severe burns will be enrolled within 24 hours of admission after obtaining informed consent. Minimum sample needed for statistical significance was calculated a priori and found to be (60). After consent, Patients' characteristics (age, sex, etc….), clinical parameters (TBSA, Abbreviated Burn Severity Index [ABSI], presence of inhalational injury), and comorbidities will be recorded. Patients will be evaluated on days 0,1, 3, 5, 7 of admission for diagnosis of ARDS. ARDS will be determined using the pediatric ARDS criteria from the Pediatric Acute Lung Injury Consensus Conference .
Who may be able to join
- Age 1-12 years.
- Patients presenting within 24 hours of burn injury.
- Patients presenting with severe burns 20-40% of total body surface area (TBSA).
- Thermal burns or scalds.
- Both sexes.
Who cannot join
- Patient refusal to participate in the trial.
- Age <1 \& >12 years.
- Delayed admission >24h post-injury.
- Patients presenting with burns <20% or >40% of TBSA.
- Non-thermal burns.
- Associated medical comorbidities: Chronic liver or kidney diseases, anemia.
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- Preexisting chronic lung disease (e.g., cystic fibrosis, severe bronchopulmonary dysplasia).
- Inflammatory conditions (e.g., inflammatory bowel disease).
- Immunocompromised individuals, autoimmune diseases, those undergoing treatment with immunosuppressants, corticosteroids, cytotoxic chemotherapy.
- Known malignancies, hematologic malignancy or conditions altering WBC/platelets significantly.
- Previous malnutrition.
- Immunosuppressive therapy prior to admission (e.g., chronic steroids).
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the role of Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as predictors for development of ARDS in pediatric burn patients.
Read the detailed description
The aim of this study is to evaluate the role of Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as predictors for development of ARDS in pediatric burn patients.
- A prospective observational cohort study will be performed in our burn ICU at Ain Shams University Hospitals. Ethical clearance will be taken from the institutional ethics committee. Written informed consent will be obtained from the patients/authorized representatives of the patients.
- All eligible pediatric patients with severe burns will be enrolled within 24 hours of admission after obtaining informed consent.
- Minimum sample needed for statistical significance was calculated a priori and found to be (60).
- After consent, Patients' characteristics (age, sex, etc….), clinical parameters (TBSA, Abbreviated Burn Severity Index [ABSI], presence of inhalational injury), and comorbidities will be recorded.
- Complete blood count (CBC) will be done upon admission and will be repeated on days 1, 3, 5 and 7.
- Total leucocyte count (TLC), differential leucocyte count (DLC) and platelet count (PC) will be reported as part of the CBC results. NLR and PLR will be calculated as per the following: NLR: ratio of absolute neutrophil count to absolute lymphocyte count. PLR: ratio of platelet counts to absolute lymphocyte count.
- Data about respiratory status at ICU admission (invasive or non-invasive mechanical ventilation, high-flow oxygen therapy) and progression to endotracheal intubation and invasive mechanical ventilation (IMV), the day of endotracheal intubation and IMV initiation, and duration of ventilation will be recorded.
- Patients will be evaluated on days 0,1, 3, 5, 7 of admission for diagnosis of ARDS.
- ARDS will be determined using the pediatric ARDS criteria from the Pediatric Acute Lung Injury Consensus Conference.
Primary outcome:
- To evaluate the predictive value of admission NLR and PLR for development of ARDS within 30 days in pediatric burn patients.
Secondary outcomes:
- Determine optimal cut-off values (ROC) of NLR and PLR for ARDS prediction.
- Compare predictive performance of NLR and PLR with established clinical predictors (TBSA%, inhalation injury, age).
- Study the predictive value of the dynamic changes of NLR/PLR for mechanical ventilation need, ventilator days, ICU length of stay, and mortality.
- Being tested
- Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte RatiosDiagnostic test
Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Powerful Predictors of ARDS in Pediatric Burn Patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil to Lymphocyte ratio (NLR) and Platelet to Lymphocyte ratio (PLR) for acute respiratory distress syndrome (ARDS) prediction using the Pediatric Index of Mortality 2 score (PIM2 score).
the predictive value of admission Neutrophil to Lymphocyte ratio (NLR) and Platelet to Lymphocyte ratio (PLR) for acute respiratory distress syndrome (ARDS) prediction within 30 days in 60 pediatric burn patients using the Pediatric Index of Mortality 2 score (PIM2 score). The PIM2 score outputs a probability of death between 0% and 100%, the higher the score, the higher the motality risk. Low risk: <5-10% predicted mortality; Moderate risk: 10-20%; High risk: >20%
Measured: Within 30 days
Secondary outcomes (3)
optimal cut-off values
optimal cut-off values (Receiver Operating Characteristic curve "ROC") of Neutrophil to Lymphocyte ratio (NLR) and Platelet to Lymphocyte ratio (PLR) for acute respiratory distress syndrome (ARDS) prediction in 60 pediatric burn patients.
Measured: 30 days
comparison between Neutrophil to Lymphocyte ratio (NLR) and Platelet to Lymphocyte ratio (PLR) in clinical aspects using pediatric risk of mortality score (PRISM III score)
Compare predictive performance of Neutrophil to Lymphocyte ratio (NLR) and Platelet to Lymphocyte ratio (PLR) with established clinical predictors (Total Body Surface Area Percentage "TBSA%", inhalation injury, age in years) in 60 pediatric burn patients using pediatric risk of mortality score (PRISM III score). PRISM III Score Ranges from 0 to >25. 0-5 means Low risk of mortality, mild critical illness; 6-15 means Moderate risk; significant physiologic instability; 16-25 means High risk; severe multi-organ involvement; >25 means Extremely high risk; very critical state.
Measured: 30 days
Dynamic changes of Neutrophil to Lymphocyte ratio (NLR) and Platelet to Lymphocyte ratio (PLR) using the Pediatric Logistic Organ Dysfunction (PELOD) score to assess severity of burn.
Study the predictive value of the dynamic changes of Neutrophil to Lymphocyte ratio (NLR) and Platelet to Lymphocyte ratio (PLR) for mechanical ventilation need, ventilator days, ICU length of stay in days, and mortality in 60 pediatric burn patients using the Pediatric Logistic Organ Dysfunction (PELOD) score. Maximum score: 33. Higher scores indicate greater severity. Higher PELOD-2 scores and involvement of multiple organ systems correlate with increased risk of mortality. A score >10 or involvement of >2 organs indicates significantly elevated risk.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start10 Nov 2025
- Primary completion10 Sep 2026
- Study completion10 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414056
- Sponsor's protocol ID
- FMASU MD313/2025
- Status last verified
- Feb 2026
- First submitted
- 24 Jan 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turning Ratios Into Prognosis: Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Powerful Predictors of ARDS in Pediatric Burn Patients: A Prospective Evaluation
- ClinicalTrials.gov ID
- NCT07414056
- Acronym / sponsor ID
- FMASU MD313/2025
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 10 Sep 2026 (actual)
- Study completion
- 10 Sep 2026 (actual)
- First posted
- 17 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 evaluate the role of Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as predictors for development of ARDS in pediatric burn patients.
Detailed description
The aim of this study is to evaluate the role of Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as predictors for development of ARDS in pediatric burn patients.
- A prospective observational cohort study will be performed in our burn ICU at Ain Shams University Hospitals. Ethical clearance will be taken from the institutional ethics committee. Written informed consent will be obtained from the patients/authorized representatives of the patients.
- All eligible pediatric patients with severe burns will be enrolled within 24 hours of admission after obtaining informed consent.
- Minimum sample needed for statistical significance was calculated a priori and found to be (60).
- After consent, Patients' characteristics (age, sex, etc….), clinical parameters (TBSA, Abbreviated Burn Severity Index [ABSI], presence of inhalational injury), and comorbidities will be recorded.
- Complete blood count (CBC) will be done upon admission and will be repeated on days 1, 3, 5 and 7.
- Total leucocyte count (TLC), differential leucocyte count (DLC) and platelet count (PC) will be reported as part of the CBC results. NLR and PLR will be calculated as per the following: NLR: ratio of absolute neutrophil count to absolute lymphocyte count. PLR: ratio of platelet counts to absolute lymphocyte count.
- Data about respiratory status at ICU admission (invasive or non-invasive mechanical ventilation, high-flow oxygen therapy) and progression to endotracheal intubation and invasive mechanical ventilation (IMV), the day of endotracheal intubation and IMV initiation, and duration of ventilation will be recorded.
- Patients will be evaluated on days 0,1, 3, 5, 7 of admission for diagnosis of ARDS.
- ARDS will be determined using the pediatric ARDS criteria from the Pediatric Acute Lung Injury Consensus Conference.
Primary outcome:
- To evaluate the predictive value of admission NLR and PLR for development of ARDS within 30 days in pediatric burn patients.
Secondary outcomes:
- Determine optimal cut-off values (ROC) of NLR and PLR for ARDS prediction.
- Compare predictive performance of NLR and PLR with established clinical predictors (TBSA%, inhalation injury, age).
- Study the predictive value of the dynamic changes of NLR/PLR for mechanical ventilation need, ventilator days, ICU length of stay, and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- A prospective observational cohort study will be performed in our burn ICU at Ain Shams University Hospitals. Ethical clearance will be taken from the institutional ethics committee. Written informed consent will be obtained from the patients/authorized representatives of the patients. All eligible pediatric patients with severe burns will be enrolled within 24 hours of admission after obtaining informed consent. Minimum sample needed for statistical significance was calculated a priori and found to be (60). After consent, Patients' characteristics (age, sex, etc….), clinical parameters (TBSA, Abbreviated Burn Severity Index [ABSI], presence of inhalational injury), and comorbidities will be recorded. Patients will be evaluated on days 0,1, 3, 5, 7 of admission for diagnosis of ARDS. ARDS will be determined using the pediatric ARDS criteria from the Pediatric Acute Lung Injury Consensus Conference .
Key inclusion criteria (5 listed)
- Age 1-12 years.
- Patients presenting within 24 hours of burn injury.
- Patients presenting with severe burns 20-40% of total body surface area (TBSA).
- Thermal burns or scalds.
- Both sexes.
Key exclusion criteria (12 listed)
- Patient refusal to participate in the trial.
- Age <1 \& >12 years.
- Delayed admission >24h post-injury.
- Patients presenting with burns <20% or >40% of TBSA.
- Non-thermal burns.
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 |
|---|---|---|
| Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte RatiosNeutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Powerful Predictors of ARDS in Pediatric Burn Patients | Diagnostic test | – |
Primary outcome
Neutrophil to Lymphocyte ratio (NLR) and Platelet to Lymphocyte ratio (PLR) for acute respiratory distress syndrome (ARDS) prediction using the Pediatric Index of Mortality 2 score (PIM2 score).
Time frame: Within 30 days
the predictive value of admission Neutrophil to Lymphocyte ratio (NLR) and Platelet to Lymphocyte ratio (PLR) for acute respiratory distress syndrome (ARDS) prediction within 30 days in 60 pediatric burn patients using the Pediatric Index of Mortality 2 score (PIM2 score). The PIM2 score outputs a probability of death between 0% and 100%, the higher the score, the higher the motality risk. Low risk: <5-10% predicted mortality; Moderate risk: 10-20%; High risk: >20%
3 secondary outcomes
optimal cut-off values
Time frame: 30 days
comparison between Neutrophil to Lymphocyte ratio (NLR) and Platelet to Lymphocyte ratio (PLR) in clinical aspects using pediatric risk of mortality score (PRISM III score)
Time frame: 30 days
Dynamic changes of Neutrophil to Lymphocyte ratio (NLR) and Platelet to Lymphocyte ratio (PLR) using the Pediatric Logistic Organ Dysfunction (PELOD) score to assess severity of burn.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Respiratory Distress Syndrome (ARDS), 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 12 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: finished, as of the sponsor's last update on 1 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neutrophil to Lymphocyte ratio (NLR) and Platelet to Lymphocyte ratio (PLR) for acute respiratory distress syndrome (ARDS) prediction using the Pediatric Index of Mortality 2 score (PIM2 score). (time frame: Within 30 days). 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 1 Oct 2026.