Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07414056
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.
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:
NCT07414056
Study Brief:
Protocol Section:
NCT07414056