Nebulized 3% Hypertonic Saline Solution Treatment of Bronchiolitis in Infants
Condition: Bronchiolitis; Wheezing
MeSH terms: Bronchiolitis; Respiratory Sounds
Study type: Interventional
Phase: Phase 4

Summary: 
      - Determine the efficacy of nebulized salbutamol/hypertonic saline combination in moderate to
      severe bronchiolitis.
    

Detailed description: 
      -  Study design: double-blind, randomized, parallel-controlled prospective study.

        -  Location: Department of pediatric emergencies and pediatric hospitalization of Highly
           Specialized Medical Unit (HSMU), Hospital of Gynecology-Obstetrics and Paediatrics
           (HGOP) No. 48, Mexican Institute of Social Security (MISS).

        -  Patients: 50 patients were included; 25 for each group. Patients had between 2 and 24
           months of age with a first episode of wheezing associated with respiratory distress and
           a history of infection of the upper respiratory tract, with moderate to severe degree of
           respiratory distress according to the Respiratory Distress Scale of Sant Joan de Déu
           Hospital (SJDH) .

        -  Interventions: the randomly allocated patients received in group I nebulised 0.9% saline
           with salbutamol 100 micrograms / kg / dose for 3 initial sessions lasting 20 minutes
           each and every 4 hours. In group II , hypertonic (3%) saline plus salbutamol 100
           micrograms / kg / dose for 3 initial sessions lasting 20 minutes each and every 4 hours.
           In both groups, will be performed at baseline Scale SJDH Respiratory Distress and the
           end of the first 3 sessions, you will have 30 minutes to make the second evaluation and
           at 4 hours the third at 8 hours and then every 24 hours throughout the hospital stay .
           The independent variable is the intervention with hypertonic saline 3% and the variable
           primary outcome will be assessed improvement or cure with Respiratory Distress Scale
           SJDH and secondary outcome will be the time of hospital stay .

        -  Descriptive statistics of all variables will be reported. T test was used for two
           independent groups or nonparametric test according to the distribution of the variables
           to compare the clinical improvement between the groups with the Scale of Respiratory
           Distress SJDH, as well as to determine whether there is a difference in time of hospital
           stay between the two study groups. Square test or Fisher exact chi used to compare
           readmissions for bronchial hyperresponsiveness between the two groups as well as the
           complications of the disease itself in each study group. Be reported with frequencies
           and percentages side effects of hypertonic saline 3%. Was considered statistically
           significant p <0.05. The results with the Number Cruncher Statistical System (NCSS) 2004
           statistical program will be discussed.

        -  The sample size was calculated with t-test to compare means of continuous variables,
           resulting in 25 subjects per group.

        -  In the follow-up period it was possible to obtain more patients from the baseline
           estimate of the sample number.
    

Intervention name(s): 0.9% Sodium Chloride; 3% Sodium Chloride
Intervention type(s): Drug; Drug
Intervention description(s): Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.; Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
Other intervention name(s): 0.9% saline; 3% saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bronchiolitis; hypertonic; saline; salbutamol