- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07414056
Transformar Proporções em Prognóstico: As Proporções Neutrófilo-Linfócito e Plaqueta-Linfócito como Poderosos Preditores de SDRA em Pacientes Pediátricos com Queimaduras: Uma Avaliação Prospectiva
Transformando Razões em Prognóstico: As Razões Neutrófilo-Linfócito e Plaqueta-Linfócito como Poderosos Preditores de SDRA em Pacientes Pediátricos Queimados: Uma Avaliação Prospectiva
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.
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Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Cairo, Egito
- Ain Shams University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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 .
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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).
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
optimal cut-off values
Prazo: 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
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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)
Prazo: 30 days
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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
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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.
Prazo: 30 days
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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
|
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Outros números de identificação do estudo
- FMASU MD313/2025
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