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临床试验/NCT06547749
NCT06547749尚未招募不适用

Assessment of Serum Vitamin D Status and Its Association With Disease Severity and Mortality Risk Among Critically Ill Children With Acute Respiratory Infections: A Cross-Sectional Study

Assiut University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2026年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
63
试验地点
1
主要终点
Hospital length of stay

研究概览

简要总结

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.

详细描述

Acute respiratory infections remain a major global health problem and are a leading cause of morbidity and mortality among pediatric populations, particularly in low- and middle-income countries. Critically ill children admitted to pediatric intensive care units (PICUs) with severe respiratory infections are at increased risk of complications, prolonged hospitalization, and mortality. Identifying modifiable risk factors associated with disease severity and poor outcomes is therefore of significant clinical importance.

Vitamin D is a fat-soluble steroid hormone traditionally recognized for its role in calcium and phosphorus homeostasis and skeletal development. However, increasing evidence has demonstrated that vitamin D also has immunomodulatory functions through its effects on innate and adaptive immunity. Vitamin D receptors are expressed in immune cells, including macrophages and respiratory epithelial cells, supporting its role in host defense against respiratory pathogens.

Recent studies have suggested an association between vitamin D deficiency and increased susceptibility to acute respiratory infections, sepsis, and adverse outcomes in critically ill children. Nevertheless, available evidence remains inconsistent, and data from pediatric intensive care populations in Egypt and similar settings are limited.

This cross-sectional observational study will be conducted at the Pediatric Intensive Care Unit of Assiut University Children's Hospital. The study will include children aged 1 month to 16 years admitted with acute respiratory infections. Patients with chronic illnesses affecting vitamin D metabolism, severe immunodeficiency, congenital heart disease, malnutrition, rickets, or recent vitamin D supplementation will be excluded.

At PICU admission, all eligible participants will undergo detailed history taking, complete clinical examination, and laboratory investigations. Serum 25-hydroxyvitamin D [25(OH)D] levels will be measured within the first 24 hours of admission as the standard indicator of vitamin D status. Vitamin D levels will be categorized according to international clinical practice guidelines into deficiency, insufficiency, sufficiency, and toxicity.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Month 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Children with known chronic bone diseases or metabolic disorders.
  • Patients receiving vitamin D supplementation prior to admission.
  • Patients with chronic renal or hepatic failure.

结局指标

主要结局

Hospital length of stay

时间窗: Baseline

How long the patient will stay in Hospital

Ventilator free day

时间窗: Baseline

How long is the free days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Ali Hassan Mohamed

Assistant Lecturer

Assiut University

研究点 (1)

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