Nebulized 3% Hypertonic Saline Solution Treatment of Bronchiolitis in Infants

Coordinación de Investigación en Salud, Mexico

Status and phase: Completed; Phase 4

Conditions: Wheezing; Bronchiolitis

Treatments: Drug: 3% Sodium Chloride; Drug: 0.9% Sodium Chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT02233985

R-2012-1002-43

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 2 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All pediatric patients aged 2 months to 24 months of age, both genders attending the pediatric emergency service.
• With first episode of wheezing associated with respiratory distress and a history of upper respiratory tract infection.
• You have the evaluation of respiratory difficulty with Scale Hospital Sant Joan de Deu (HSJD) from 6 to 16 at entry points (moderate and severe degree).

Exclusion criteria

• Subjects with a history of previous wheezing, asthma, or who have received bronchodilator treatment before the present illness.
• Subjects with chronic lung disease, with heart disease, with congenital or acquired anatomic abnormalities of the airway.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups

Nebulized 0.9% Sodium Chloride

Active Comparator group

Description:

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.

Treatment:

Drug: 0.9% Sodium Chloride

Nebulized 3% Sodium Chloride

Experimental group

Description:

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.

Treatment:

Drug: 3% Sodium Chloride