About this trial
Acute respiratory infections (ARIs) are among the leading causes of hospitalization, morbidity, and mortality in children worldwide, particularly among critically ill patients admitted to pediatric intensive care units (PICUs). Vitamin D has an important role not only in bone metabolism but also in regulation of innate and adaptive immune responses, especially within the respiratory tract. Recent evidence suggests that vitamin D deficiency may be associated with increased susceptibility to respiratory infections, greater disease severity, prolonged hospitalization, and higher mortality rates in critically ill children.
This observational cross-sectional study aims to assess serum vitamin D status among critically ill children admitted to the PICU with acute respiratory infections and to evaluate the relationship between vitamin D levels, severity of respiratory illness, and risk of mortality. The study will include pediatric patients aged 1 month to 16 years admitted to the Pediatric Intensive Care Unit of Assiut University Children's Hospital.
Clinical evaluation and laboratory investigations, including serum 25-hydroxyvitamin D levels, serum calcium, and alkaline phosphatase, will be performed within the first 24 hours of admission. Severity of respiratory distress will be assessed using the Pediatric Respiratory Severity Score (PRESS), while mortality risk will be evaluated using the Pediatric Risk of Mortality Score (PRISM III).
The findings of this study may contribute to better understanding of the role of vitamin D in critically ill children with respiratory infections and may support future strategies for early risk assessment and improved clinical management in pediatric intensive care settings.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged between 1 month and 12 years.
Admitted to the PICU with a primary diagnosis of acute respiratory infection.
Diagnosis confirmed by clinical symptoms and radiological evidence.
Disqualifiers
Children with known chronic bone diseases or metabolic disorders.
Patients receiving vitamin D supplementation prior to admission.
Patients with chronic renal or hepatic failure.
Trial population
The study involves pediatric patients admitted to the Pediatric Intensive Care Unit (PICU) at a tertiary care hospital who meet the diagnostic criteria for acute respiratory infections.
Trial design
Cohort
Prospective
Treatments tested in this trial
Serum 25-Hydroxyvitamin D Assessment
Diagnostic testBlood samples will be collected within the first 24 hours of admission to the Pediatric Intensive Care Unit (PICU) to measure serum 25-hydroxyvitamin D \[25(OH)D\] levels, which is the standard biomarker used to assess vitamin D status. The measured vitamin D levels will be analyzed in relation to the severity of acute respiratory infections using the Pediatric Respiratory Severity Score (PRESS) and the risk of mortality using the Pediatric Risk of Mortality Score (PRISM III). No therapeutic intervention or vitamin D supplementation will be administered as part of the study protocol.
Treatment groups
Trial outcomes
Primary outcomes
Prevalence of Vitamin D Deficiency among critically ill children with acute respiratory infections.
This measure evaluates the baseline vitamin D status of pediatric patients admitted to the PICU with acute respiratory infections. Vitamin D status is determined by measuring serum 25-hydroxyvitamin D \[25(OH)D\] levels. According to the Endocrine Society guidelines, deficiency is defined as levels \<20 ng/mL.
Secondary outcomes
Association between Vitamin D and Severity of ARI
Analysis of the relationship between serum vitamin D levels and the severity of acute respiratory infections (ARI) as measured by the Pediatric Respiratory Severity Score (PRESS). The PRESS score (0-5) categorizes distress as mild, moderate, or severe.
Association between Vitamin D and Risk of Mortality
Analysis of the relationship between serum vitamin D levels and the risk of mortality as assessed by the Pediatric Risk of Mortality score (PRISM III). This score is based on 17 physiological variables.
Sponsors and contacts
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