NCT01295398Unknown不适用
Influence of the Nebulizer on the Clinical Efficacy of Hypertonic Saline 3% in Children Aged Less Than 18 Months and Hospitalized With Acute Viral Bronchiolitis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- the improvement of the clinical score of severity at the 48th hour between the 3 groups of children
研究概览
简要总结
The aim of the investigators study is to compare in children aged less than 18 months and hospitalized for an acute viral bronchiolitis the efficacy of the HS 3% (Mucoclear®, sterile ampoules of 4 ml) nebulised with a conventional jet-nebulizer (particles diameter of 4-5 µm), or with a jet-nebulizer adapted for infants (particles diameter of 2-2.5 µm), or with a mesh-nebulizer adapted for infants (particles diameter of 2-2.5 µm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 28 Days 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant of less than 18 months old
- •infant hospitalized for a 1st episode of bronchiolitis defined as a 1st episode of respiratory difficulty with sibilant and\or crépitants in a viral context (head cold and\or cough and\or fever and\or notion of contage)
- •Necessity of an clinical score upper to
- •This clinical score, described by Wang in 1992, is the clinical score classically used in the studies concerning the acute(sharp) bronchiolitis of the infant ( 8,9,12 ). He(it) is at most on 12 points.
- •absence of respiratory décompensation requiring an admission in Unity of Pediatric Intensive care
- •signature of the Informed consent
- •Membership in a national insurance
排除标准
- •Refusal of the parents to participate in the study
- •18-month-old infant hospitalized for acute(sharp) bronchiolitis with a clinical score lower than
- •signs of respiratory décompensation requiring a transfer in resuscitation, signs of hypercapnie or episodes of apneas
- •histories of bronchiolitis or asthma of the infant
- •cardiac underlying pathology, respiratory, neuromuscular, immunodeficient or former premature of less of 34 weeks of amenorrhoea and less than 3 months of corrected age.
- •child having set within 6 hours preceding the inclusion a treatment by bronchodilatateurs or corticoids by systematic or inhaled way.
研究组 & 干预措施
conventional jet-nebulizer
Other
(particles diameter of 4-5 µm)
干预措施: nebulisations (Device)
a jet-nebulizer adapted for infants
Experimental
(particles diameter of 2-2.5 µm),
干预措施: nebulisations (Device)
a mesh-nebulizer adapted for infants
Experimental
(particles diameter of 2-2.5 µm).
干预措施: nebulisations (Device)
结局指标
主要结局
the improvement of the clinical score of severity at the 48th hour between the 3 groups of children
时间窗: 12 months
次要结局
- the number of children requiring oxygen(12 months)
- tolerance of the nebulisations(12 months)
- the number of complications.(12 months)
- the number of parenteral nutrition(12 months)
研究者
研究点 (1)
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