A Randomized Controlled Trial of Nebulized Hypertonic Saline Treatment in Hospitalized Children With Moderate to Severe Viral Bronchiolitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 主要终点
- To determine the efficacy of frequently nebulized HS in moderately to severely ill infants with bronchiolitis
研究概览
简要总结
The purpose of this study is planned to investigate whether frequently inhaled hypertonic saline (HS) can relieve symptoms and signs faster than normal saline (NS) and shorten length of stay (LOS) significantly for moderately to severely ill infants with bronchiolitis without apparent adverse effects.
详细描述
The treatment of bronchiolitis remains largely supportive with mechanical ventilatory support as needed .Other types of treatment remain controversial.We and other researchers have demonstrated that nebulized HS and bronchodilators decreased symptoms and LOS for infants with mild to moderate viral bronchiolitis .All the aforementioned studies used 3 times per day dosing, which is significantly less than the 3 to 6 times per hour regimens often used in children in respiratory distress.Frequently nebulized HS reduced the LOS for infants with moderately severe bronchiolitis.The present study is planned to investigate whether frequently inhaled HS can relieve symptoms and signs faster than NS and shorten LOS significantly for moderately to severely ill infants with bronchiolitis without apparent adverse effects.
PMID: 15266547 PMID: 12576370 PMID: 16599051 PMID: 17719935 PMID: 20014350 PMID: 12475841
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 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 first episode of wheezing.
排除标准
- •age>24 months,
- •previous episode of wheezing,
- •chronic cardiac and pulmonary disease,
- •immunodeficiency,
- •accompanying respiratory failure,
- •requiring mechanical ventilation,
- •inhaling the nebulized 3% hypertonic saline solution 12 hours before treatment,
- •premature infants born at less than 34 weeks gestation.
研究组 & 干预措施
hypertonic saline
hypertonic saline (HS)
干预措施: 3% hypertonic saline (Drug)
normal saline (NS)
normal saline (NS)
干预措施: normal saline (Drug)
结局指标
主要结局
To determine the efficacy of frequently nebulized HS in moderately to severely ill infants with bronchiolitis
时间窗: 1 year
Compare the wheezing remission time,Cough remission time,moist crackles disappeared time and the hospital length of stay between HS and NS.
次要结局
- To determine the safety of frequently nebulized HS in moderately to severely ill infants with bronchiolitis(1 year)