Nebulized 3% Hypertonic Saline Solution Treatment of Bronchiolitis in Infants

Phase 4

Completed

• Conditions: Bronchiolitis; Wheezing
• Interventions: Drug: 0.9% Sodium Chloride; Drug: 3% Sodium Chloride

• Registration Number: NCT02233985
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

Brief 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.

Study Timeline

• Status Verified: 2012-12
• Study Start: 2013-08
• Study First Submitted: 2014-05-07
• Study First Submitted QC: 2014-09-04
• Study First Posted: 2014-09-09
• Results First Submitted: 2016-04-18
• Results First Submitted QC: 2017-01-25
• Primary Completion: 2017-02
• Study Completion: 2017-03
• Results First Posted: 2017-03-15
• Last Update Submitted: 2017-05-29
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nebulized 0.9% Sodium Chloride	0.9% Sodium Chloride	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.
Nebulized 3% Sodium Chloride	3% Sodium Chloride	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.

Primary Outcome Measures

Name	Time	Method
Score Respiratory Distress	Basal, 30 minutes after the end of the first 3 continuous nebulization sessions, at 4 hours, 8 hours and every 24 hours during the entire hospital stay	It is a validated clinical scale, sufficiently reliable measure of Severity of the respiratory distress. It consists of the summation score of the sibilance / crackling parameters (the largest of them), respiratory effort, pulmonary air inlet, oxygen saturation, heart rate and breathing rate. It is stratified into 3 levels of severity: mild from 0 to 5 points, moderate from 6 to 10 and severe from 10 to 16.
Hours of Hospital Stay	Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.	Each patient record the time of entry and measured the total hospital stay time in hours, recording the time of discharge to determine the total stay in hours. The hospital stay will be evaluated in hours. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.

Secondary Outcome Measures

Name	Time	Method
Hospital Readmission	Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.	After the first admission of each patient will be evaluated during the next 30 days, if a patient is readmitted for any respiratory disease, respiratory distress, pneumonia or bronchiolitis. Considering as non-serious risks that do not compromise life, tachycardia, tremor, increased access to cough immediately to the inhalation, as well as the ardor of nasal mucosa, all these with limited characteristics, however, these do not put at risk The health of the patient, so they were not measured.
Frequency of Complications of the Disease Itself	Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.	The presence or absence of clinical data to warrant dehydration of hydration, infected by bacteria, pneumothorax, interstitial emphysema and subcutaneous be evaluated.

Trial Locations

Locations (1)

Unidad Medica de Alta Especialidad Bajío No. 48 Hospital de Gineco - Pediatría. Instituto Mexicano del Seguro Social; 🇲🇽 Leon, Guanajuato, Mexico