Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 8:33 PM
Study NCT ID:
NCT07414056
Status:
RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-11-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-01-24', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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).', 'timeFrame': 'Within 30 days', 'description': '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%'}], 'secondaryOutcomes': [{'measure': 'optimal cut-off values', 'timeFrame': '30 days', 'description': '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.'}, {'measure': '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)', 'timeFrame': '30 days', 'description': '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.'}, {'measure': '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.', 'timeFrame': '30 days', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Respiratory Distress Syndrome (ARDS)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\n* 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.\n* All eligible pediatric patients with severe burns will be enrolled within 24 hours of admission after obtaining informed consent.\n* Minimum sample needed for statistical significance was calculated a priori and found to be (60).\n* After consent, Patients' characteristics (age, sex, etc….), clinical parameters (TBSA, Abbreviated Burn Severity Index \\[ABSI\\], presence of inhalational injury), and comorbidities will be recorded.\n* Complete blood count (CBC) will be done upon admission and will be repeated on days 1, 3, 5 and 7.\n* 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.\n* 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.\n* Patients will be evaluated on days 0,1, 3, 5, 7 of admission for diagnosis of ARDS.\n* ARDS will be determined using the pediatric ARDS criteria from the Pediatric Acute Lung Injury Consensus Conference.\n\nPrimary outcome:\n\no To evaluate the predictive value of admission NLR and PLR for development of ARDS within 30 days in pediatric burn patients.\n\nSecondary outcomes:\n\n* Determine optimal cut-off values (ROC) of NLR and PLR for ARDS prediction.\n* Compare predictive performance of NLR and PLR with established clinical predictors (TBSA%, inhalation injury, age).\n* Study the predictive value of the dynamic changes of NLR/PLR for mechanical ventilation need, ventilator days, ICU length of stay, and mortality."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "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.\n\nAll eligible pediatric patients with severe burns will be enrolled within 24 hours of admission after obtaining informed consent.\n\nMinimum sample needed for statistical significance was calculated a priori and found to be (60).\n\nAfter consent, Patients' characteristics (age, sex, etc….), clinical parameters (TBSA, Abbreviated Burn Severity Index \\[ABSI\\], presence of inhalational injury), and comorbidities will be recorded.\n\nPatients will be evaluated on days 0,1, 3, 5, 7 of admission for diagnosis of ARDS.\n\nARDS will be determined using the pediatric ARDS criteria from the Pediatric Acute Lung Injury Consensus Conference .", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 1-12 years.\n* Patients presenting within 24 hours of burn injury.\n* Patients presenting with severe burns 20-40% of total body surface area (TBSA).\n* Thermal burns or scalds.\n* Both sexes.\n\nExclusion Criteria:\n\n* Patient refusal to participate in the trial.\n* Age \\<1 \\& \\>12 years.\n* Delayed admission \\>24h post-injury.\n* Patients presenting with burns \\<20% or \\>40% of TBSA.\n* Non-thermal burns.\n* Associated medical comorbidities: Chronic liver or kidney diseases, anemia.\n* Preexisting chronic lung disease (e.g., cystic fibrosis, severe bronchopulmonary dysplasia).\n* Inflammatory conditions (e.g., inflammatory bowel disease).\n* Immunocompromised individuals, autoimmune diseases, those undergoing treatment with immunosuppressants, corticosteroids, cytotoxic chemotherapy.\n* Known malignancies, hematologic malignancy or conditions altering WBC/platelets significantly.\n* Previous malnutrition.\n* Immunosuppressive therapy prior to admission (e.g., chronic steroids).'}, 'identificationModule': {'nctId': 'NCT07414056', 'briefTitle': 'Turning Ratios Into Prognosis: Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Powerful Predictors of ARDS in Pediatric Burn Patients: A Prospective Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Turning Ratios Into Prognosis: Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Powerful Predictors of ARDS in Pediatric Burn Patients: A Prospective Evaluation', 'orgStudyIdInfo': {'id': 'FMASU MD313/2025'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios', 'type': 'DIAGNOSTIC_TEST', 'description': 'Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Powerful Predictors of ARDS in Pediatric Burn Patients'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Kamal Kamar Kamar, M.B.B.CH., M.Sc.', 'role': 'CONTACT', 'email': 'ahmedkamar@med.asu.edu.eg', 'phone': '00201027733119'}, {'name': 'Ain Shams University', 'role': 'CONTACT', 'email': 'ahmed_kamal_2amar@hotmail.com'}], 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}