A Randomized Trial of Nebulized 3% Hypertonic Saline With Salbutamol in the Treatment of Acute Bronchiolitis in Pediatric Hospital

Nebulized 3% Hypertonic Saline Solution Treatment of Bronchiolitis in Infants

Sponsors

Lead sponsor: Coordinación de Investigación en Salud, Mexico

Source 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.

Overall Status Completed
Start Date August 2013
Completion Date March 2017
Primary Completion Date February 2017
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
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
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
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
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.
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.
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.
Secondary Outcome
Measure Time Frame
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.
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.
Enrollment 64
Condition
Intervention

Intervention type: Drug

Intervention name: 0.9% Sodium Chloride

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.

Arm group label: Nebulized 0.9% Sodium Chloride

Other name: 0.9% saline

Intervention type: Drug

Intervention name: 3% Sodium Chloride

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.

Arm group label: Nebulized 3% Sodium Chloride

Other name: 3% saline

Eligibility

Criteria:

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.

Gender: All

Minimum age: 2 Months

Maximum age: 24 Months

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Gloria P Sosa-Bustamante, MD Study Director Unidad Medica de Alta Especialidad Bajio 48. Hospital de Gineco - Pediatria. Instituto Mexicano del Seguro Social
Location
facility
Unidad Medica de Alta Especialidad Bajío No. 48 Hospital de Gineco - Pediatría. Instituto Mexicano del Seguro Social
Location Countries

Mexico

Verification Date

December 2012

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Nebulized 0.9% Sodium Chloride

Arm group type: Active Comparator

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.

Arm group label: Nebulized 3% Sodium Chloride

Arm group type: Experimental

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.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov