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临床试验/NCT03880903
NCT03880903Unknown4 期

A Prospective Study on the Use of Hypertonic Saline Inhalation in Acute Bronchiolitis in Children

Assiut University0 个研究点目标入组 75 人开始时间: 2020年7月20日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Experimental

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

Experimental

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

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

MASamoael

principle investigator

Assiut University

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