Effectiveness of hipertonic saline serum 3% nebulized in bronchiolitis

Conditions: Bronchiolitis
MedDRA version: 14.1Level: LLTClassification code 10000688Term: Acute bronchitis and bronchiolitisSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2010-024230-35-ES

Lead Sponsor: Fundacion par la investigación biomédica del Hospital Universitario La Paz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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