EUCTR2010-024230-35-ES进行中(未招募)不适用
Effectiveness of hipertonic saline serum 3% nebulized in bronchiolitis - EMABRHIP
Fundacion par la investigación biomédica del Hospital Universitario La Paz0 个研究点开始时间: 2012年2月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age between 7 days and 6 months.
- •Diagnosis of moderate-serious bronchiolitis (first episode of wheezing lower respiratory difficulty in the context of the upper airways viral infection ) which require hospital admission in participating sites(Score Wood-Downes modified between 4-7).
- •Informed consent from Parents or guardians according to the current legislation on clinical research (Declaration of Helsinki, Law 14/2007 of 3 July biomedical research)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 130
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Severe bronchiolitis requiring ventilation or admission to ICU when the patient has an oxygen saturation <94 with oxygen supply> 2l/min, a Score = 8 and / or PaCO2 = 65 mmHg, assessing the indication for assisted ventilation (high-flow systems, C-PAP, ventilation invasive mechanical) and / or transfer to the Pediatric Intensive Care Unit with the practice of each hospital.
- •Cardiac or pulmonary disease base.
- •Previous diagnosis of asthma.
- •Use of bronchodilators.
- •Need for cardiopulmonary resuscitation.
- •Inability to use nebulizer.
- •Concomitant use of antibiotics.
- •Use of corticosteroids.
- •No informed consent.
- •Prescribed treatment with nebulized epinephrine
研究者
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