Bronchiolitis MedDRA version: 14.1 Level: LLT Classification code 10000688 Term: Acute bronchitis and bronchiolitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Solución Fisiológica CINFA
Product Name: Not Applicable
Product Code: Not Applicable
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: Sodium Chloride (0,9%) sterile solution
C
Sponsors
Fundacion par la investigación biomédica del Hospital Universitario La Paz
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Severe bronchiolitis requiring ventilation or admission to ICU when the patient has an oxygen saturation 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: determination the efficacy (measured in reduced time until clinical normalization) of hypertonic saline 3% (SSH) compared nebulized saline (SSF) in the treatment of bronchiolitis in hospitalized patients between 7 days and 6 months age.;Secondary Objective: Compare the length of hospital stay of patients treated with nebulized SSH versus SSF nebulized. Compare the length of hospital stay, time to clinical normalization Check the safety of nebulized SSH in this population. Compare between both groups the rate of need for rescue treatment, need for respiratory support and relapse rate.;Primary end point(s): determination the efficacy (measured in reduced time until clinical normalization) of hypertonic saline 3% (SSH) compared nebulized saline (SSF) in the treatment of bronchiolitis in hospitalized patients between 7 days and 6 months age.;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Compare the length of hospital stay of patients treated with nebulized SSH versus SSF nebulized. Compare the length of hospital stay, time to clinical normalization Check the safety of nebulized SSH in this population. Compare between both groups the rate of need for rescue treatment, need for respiratory support and relapse rate.;Timepoint(s) of evaluation of this end point: 6 months 6 month 12 months 6 months | — |
Countries
Spain
Contacts
Public ContactRocío Arce
Consorcio de Apoyo para la Investigación Biomédica en Red (CAIBER)
Outcome results
None listed