Clinical trial NCT02233985: Nebulized 3% Hypertonic Saline Solution Treatment of Bronchiolitis in Infants
Official title: A Randomized Trial of Nebulized 3% Hypertonic Saline With Salbutamol in the Treatment of Acute Bronchiolitis in Pediatric Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bronchiolitis
Wheezing
Keywords: bronchiolitis
hypertonic
saline
salbutamol
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2014-09-09
Enrollment: 64
Sex: ALL
Minimum age (years): 2
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Score Respiratory Distress
timeFrame: 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
measure: Hours of Hospital Stay
timeFrame: 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 outcomes:
measure: Hospital Readmission
timeFrame: 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.
measure: Frequency of Complications of the Disease Itself
timeFrame: 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.
Other outcomes:
Locations:
city: Leon
country: Mexico
facility: Unidad Medica de Alta Especialidad Bajío No. 48 Hospital de Gineco - Pediatría. Instituto Mexicano del Seguro Social
state: Guanajuato
Study officials:
affiliation: Unidad Medica de Alta Especialidad Bajio 48. Hospital de Gineco - Pediatria. Instituto Mexicano del Seguro Social
name: Gloria P Sosa-Bustamante, MD
role: STUDY_DIRECTOR
References:
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citation: Sharma BS, Gupta MK, Rafik SP. Hypertonic (3%) saline vs 0.93% saline nebulization for acute viral bronchiolitis: a randomized controlled trial. Indian Pediatr. 2013 Aug;50(8):743-7. doi: 10.1007/s13312-013-0216-8. Epub 2012 Dec 5.
citation: Gupta N, Puliyel A, Manchanda A, Puliyel J. Nebulized hypertonic-saline vs epinephrine for bronchiolitis; proof of concept study of cumulative sum (CUSUM) analysis. Indian Pediatr. 2012 Jul;49(7):543-7. doi: 10.1007/s13312-012-0122-5. Epub 2010 Oct 30.
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citation: Grewal S, Ali S, McConnell DW, Vandermeer B, Klassen TP. A randomized trial of nebulized 3% hypertonic saline with epinephrine in the treatment of acute bronchiolitis in the emergency department. Arch Pediatr Adolesc Med. 2009 Nov;163(11):1007-12. doi: 10.1001/archpediatrics.2009.196.
citation: Luo Z, Liu E, Luo J, Li S, Zeng F, Yang X, Fu Z. Nebulized hypertonic saline/salbutamol solution treatment in hospitalized children with mild to moderate bronchiolitis. Pediatr Int. 2010 Apr;52(2):199-202. doi: 10.1111/j.1442-200X.2009.02941.x. Epub 2009 Aug 7.
citation: Postiaux G, Louis J, Labasse HC, Gerroldt J, Kotik AC, Lemuhot A, Patte C. Evaluation of an alternative chest physiotherapy method in infants with respiratory syncytial virus bronchiolitis. Respir Care. 2011 Jul;56(7):989-94. doi: 10.4187/respcare.00721. Epub 2011 Feb 22.