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Nebulized 3% Hypertonic Saline Solution Treatment of Bronchiolitis in Infants

Information source: Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bronchiolitis; Wheezing

Intervention: 0.9% Sodium Chloride (Drug); 3% Sodium Chloride (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Coordinación de Investigación en Salud, Mexico

Official(s) and/or principal investigator(s):
Gloria P Sosa-Bustamante, MD, Study Director, Affiliation: Unidad Medica de Alta Especialidad Bajio 48. Hospital de Gineco - Pediatria. Instituto Mexicano del Seguro Social

Overall contact:
Gloria P Sosa-Bustamante, MD, Phone: 01524777174800, Ext: 31804, Email: patriciasosab@hotmail.com

Summary

- Determine the efficacy of nebulized salbutamol/hypertonic saline combination in moderate

to severe bronchiolitis.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Score respiratory distress

Hours of hospital stay

Secondary outcome:

Hospital readmission

Frequency of complications of the disease itself

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.

Eligibility

Minimum age: 2 Months. Maximum age: 24 Months. Gender(s): Both.

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.

Locations and Contacts

Gloria P Sosa-Bustamante, MD, Phone: 01524777174800, Ext: 31804, Email: patriciasosab@hotmail.com

Unidad Medica de Alta Especialidad Bajío No. 48 Hospital de Gineco - Pediatría. Instituto Mexicano del Seguro Social, Leon, Guanajuato 37320, Mexico; Recruiting
Gloria P Sosa-Bustamante, MD, Phone: 015247771748000, Ext: 31804, Email: patriciasosab@hotmail.com
Sonia Lazcano, MD, Phone: 015247771748000, Ext: 31804, Email: sonialazcano@hotmail.com
Emmanuel G Martinez-Morales, MD, Principal Investigator
Gloria P Sosa-Bustamante, MD, Sub-Investigator
Additional Information

Guideline for the Management of Children Presenting With Acute Breathing Difficulty. Nottingham, United Kingdom: University of Nottingham

Related publications:

Kuzik BA, Flavin MP, Kent S, Zielinski D, Kwan CW, Adeleye A, Vegsund BC, Rossi C. Effect of inhaled hypertonic saline on hospital admission rate in children with viral bronchiolitis: a randomized trial. CJEM. 2010 Nov;12(6):477-84.

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. Epub 2012 Dec 5.

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. Epub 2010 Oct 30.

Al-Ansari K, Sakran M, Davidson BL, El Sayyed R, Mahjoub H, Ibrahim K. Nebulized 5% or 3% hypertonic or 0.9% saline for treating acute bronchiolitis in infants. J Pediatr. 2010 Oct;157(4):630-4, 634.e1. doi: 10.1016/j.jpeds.2010.04.074. Epub 2010 Jun 19.

Luo Z, Fu Z, Liu E, Xu X, Fu X, Peng D, Liu Y, Li S, Zeng F, Yang X. Nebulized hypertonic saline treatment in hospitalized children with moderate to severe viral bronchiolitis. Clin Microbiol Infect. 2011 Dec;17(12):1829-33. doi: 10.1111/j.1469-0691.2010.03304.x. Epub 2010 Jul 15.

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.

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.

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.

Starting date: August 2013
Last updated: March 27, 2015

Page last updated: August 23, 2015

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