Nebulized Hypertonic Saline for Bronchiolitis
Observational Study on the Use of Hypertonic Saline for the Treatment of Bronchiolitis
In randomized controlled trials, the use of nebulized hypertonic saline in acute bronchiolitis has been reported to improve respiratory distress scores, to reduce length of hospital stay and to show a trend towards lower hospitalization rates.
The investigators aim to verify by an observational study if the rate of hospital admission and the length of hospital stay of infants presenting to the emergency department (ED) with bronchiolitis decreases after the inclusion of 5.85% nebulized hypertonic saline in the treatment strategy of the ED and hospitalization wards.
The investigators will assess the evolution of hospital admission rates and the length of hospital stay in two hospitals that use 5.85% nebulized hypertonic saline for the treatment of bronchiolitis and in two hospital that do not use these nebulizations. If nebulized hypertonic saline is effective in this setting, then the hospitalization rates and length of stay should be lower during the year of hypertonic saline use compared to two previous years when this therapy was not used. These parameters would not be modified in centers that do not use hypertonic saline.
研究概览
地位
条件
详细说明
This is a before-after observational study designed to compare the results in terms of hospitalization rate and length of hospital stay between a period when nebulized hypertonic saline was included in the treatment of bronchiolitis in infants versus the two previous years when this therapy was not used in two hospitals. There will not be any randomization.
Physicians have been instructed on the use of hypertonic saline for moderate and severe bronchiolitis in infants but its totally up to them whether to use this nebulization for each particular patient. Two other hospital where nebulized hypertonic saline has never been used and will not be used during the next bronchiolitis epidemics will be the control centers.
The study comprises two periods, one prospective starting on November 2011 and ending in March 2012 and one retrospective including the two previous bronchiolitis epidemics, November 2009-March 2012 and November 2010-March 2011.
During the prospective period a standardized assessment of the respiratory status of each infant will be carried out before and after each hypertonic saline nebulization.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Le Chesnay、法国、78157
- Hopital de Versailles
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Paris、法国、75019
- Hôpital Robert Debré
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Paris、法国、75012
- Hôpital Armand Trousseau
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Poissy、法国、78300
- Chi Poissy Saint Germain En Laye
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Ile-de-France
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Bondy、Ile-de-France、法国、93143
- Hôpital Jean Verdier
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- All infants up to 1 year of age presenting to the ED for bronchiolitis during the study periods.
Exclusion Criteria:
- Bronchiolitis in infants older than 1 year
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Hospitalization rate
大体时间：6 MONTHS
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Comparison of hospitalization rates of infants presenting to the ED with bronchiolitis during the year of use of nebulized hypertonic saline versus the two previous years when nebulized hypertonic saline was not used.
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6 MONTHS
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Length of hospital stay
大体时间：6 months
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Comparison of lenghts of stay of infants hospitalized for bronchiolitis during the year of use of nebulized hypertonic saline in hospitalization wards versus the two previous years when nebulized hypertonic saline was not used.
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6 months
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Assessment of 5.85% hypertonic saline tolerance
大体时间：6 months
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A standardized assessment of the respiratory status will be carried out right before and after each nebulization
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6 months
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合作者和调查者
合作者
调查人员
- 首席研究员：Ricardo Carbajal, MD, PhD、Hôpital Armand Trousseau, Paris
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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