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

NCT07414056 | Recruiting

• 1 other identifier: FMASU MD313/2025
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Outcome Measures

Primary Outcomes (1)

• 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%

  Within 30 days

Secondary Outcomes (3)

• optimal cut-off values

  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)

  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.

  30 days

Interventions

Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios DIAGNOSTIC_TEST

Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Powerful Predictors of ARDS in Pediatric Burn Patients

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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 .

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 17, 2026
• Study Start: November 10, 2025
• Primary Completion (Estimated): May 10, 2027
• Study Completion (Estimated): November 10, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

EG (1)