跳至主要内容
临床试验/EUCTR2010-024230-35-ES
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

发起方
Fundacion par la investigación biomédica del Hospital Universitario La Paz

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