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临床试验/NCT02640066
NCT02640066Unknown不适用

Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children: A Single Blinded Randomized Controlled Trial

Ziv Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
presence of crepitations

研究概览

简要总结

Acute viral respiratory infections are among the most common causes of hospitalization in the pediatric population. The usual presentation of viral respiratory tract infections (VRTI) includes fever, malaise, wheezing and or coughing, rhinorrhea and loss of appetite. Up to 50% of children will have at least one viral-induced wheezing illness by school age. Currently treatment of VRTI is essentially supportive and no specific and efficient treatments are known. Given the lack of effective medications, current treatment for severe viral lower respiratory tract infection (LRTI) in infants relies on supportive measures only. These measures include supplementation of oxygen, monitoring of apnea, nasal/gastric tube feeding or intravenous fluids, and, if required, respiratory support with nasal bi-level positive-airway pressure. VTRI therefore represent an important unmet need for improved treatment strategies. Acupuncture's effect on has also been studied. Acupuncture has been shown to be a safe and effective in various respiratory tract inflammations. A review published in 2011 have found that acupuncture is safe for pediatric patients. Acupuncture's effect on acute viral induced wheezing and cough in hospitalized children has yet to be studied. Since the current standard of care is supportive care only, using acupuncture as an additional treatment may provide benefit in reducing wheezing, respiratory distress, and shorten hospitalization.

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
Single (Outcomes Assessor)

入排标准

年龄范围
3 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • The presence of acute viral respiratory disease

排除标准

  • Evidence of chronic cardio-pulmonary disease, immune-suppression or any chronic systemic disease or disability

结局指标

主要结局

presence of crepitations

时间窗: 5 days

presence of fever

时间窗: 5 days

presence of cough

时间窗: 5 days

presence of rhinitis

时间窗: 5 days

symptoms of pharyngitis

时间窗: 5 days

presence of dyspnea or tachypnea

时间窗: 5 days

respiratory rate

oxygen saturation

时间窗: 5 days

measured by (SpO2)

次要结局

未报告次要终点

研究者

发起方
Ziv Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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