Turning Ratios Into Prognosis: Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Powerful Predictors of ARDS in Pediatric Burn Patients: A Prospective Evaluation

February 27, 2026 updated by: Ain Shams University
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.

Study Overview

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:

o 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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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 .

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%
Within 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
optimal cut-off values
Time Frame: 30 days
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.
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
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.
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
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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2025

Primary Completion (Estimated)

May 10, 2027

Study Completion (Estimated)

November 10, 2027

Study Registration Dates

First Submitted

January 24, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • FMASU MD313/2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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