A Prospective Study on the Use of Hypertonic Saline Inhalation in Acute Bronchiolitis in Children
试验速览
- 阶段
- 4 期
- 入组人数
- 75
- 主要终点
- Hospital length of stay
研究概览
简要总结
Acute bronchiolitis is a viral infection that occurs in children most commonly in the first 2 years of life and is characterized by respiratory symptoms, resulting in wheezing and/or crackles upon auscultation. It is usually a self limiting illness. However, this condition may be associated with several severe complications, such as apnea,respiratory failure, or secondary bacterial infection
详细描述
Acute bronchiolitis is a viral infection that occurs in children most commonly in the first 2 years of life and is characterized by respiratory symptoms, resulting in wheezing and/or crackles upon auscultation. It is usually a self limiting illness. However, this condition may be associated with several severe complications, such as apnea,respiratory failure, or secondary bacterial infection. Bronchiolitis is a significant cause of respiratory disease worldwide. according to the World Health Organization bullet in, an estimated 150 million new cases occur annually; 11-20 million (7-13%) of these cases are severe enough to require hospital admission. Worldwide, 95% of all cases occur in developing countries. Typically, initial clinical manifestations include upper respiratory tract symptoms such as cough, nasal congestion, and low-grade fever lasting 1 to 3 days, followed by expiratory wheezing, nasal flaring, fine crackles, oxygen saturation on presentation<94%, tachypnea, increased work of breathing, use of accessory muscles, and retractions in some patients. The need for hospitalization depends on the presence of respiratory symptoms (degree of retractions, increased respiratory effort, decreased oxygen saturation), cyanosis, restlessness or lethargy, and underlying disease states, including apnea. Since no definitive antiviral therapy exists for most causes of bronchiolitis, management of these infants should be directed toward symptomatic relief and maintenance of hydration and oxygenation. One medication that has demonstrated promising results in the management of acute bronchiolitis is nebulized hypertonic saline , Its hyperosmolarity helps to absorb water from the mucosal and submucosal space, thereby increasing mucociliary function by clearing fluids accumulated in the airway and mucus plugs in the lungs. Hypertonic saline can also induce cough to help enhance mucus clearance. The American Academy Of Pediatrics guidelines recommend administration of hypertonic saline in hospitalized bronchiolitis patients. The most common dosage studied is hypertonic saline 3% 4 mL per dose inhaled by nebulizer every 4 to 6 hours, which may take ≥24 hours to work and is typically continued while the child is hospitalized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 24 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants less than 24 months of age with adiagnosis of acute bronchiolitis
排除标准
- •other infants and children above 24 months of age
- •patients with other diseases than acute bronchiolitis
研究组 & 干预措施
normal saline with bronchdilator
will recieve treatment with nebulized brochodilator(salbutamol) and normal saline every 4 to 6 hours
干预措施: normal saline and salbutamol (Drug)
hypertonic saline with bronchodilator
will recieve treatment with nebulized bronchodilator(salbutamol) and hypertonic saline every 4 to 6 hours
干预措施: hypertonic saline and salbutamol (Drug)
hypertonic saline only
will recieve treatment with nebulized hypertonic saline 3% in adose of 4 ml every 4 to 6 hours
干预措施: Hypertonic saline (Drug)
结局指标
主要结局
Hospital length of stay
时间窗: 24 hours
time taken to discharge or ready to be discharged
次要结局
未报告次要终点
研究者
MASamoael
principle investigator
Assiut University
