Nebulized 3% Hypertonic Saline Solution Treatment of Bronchiolitis in Infants

NCT02233985 | Completed Phase 4 Results DMC

• 1 other identifier: R-2012-1002-43
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bronchiolitis; Wheezing

Keywords

bronchiolitis; hypertonic; saline; salbutamol

Outcome Measures

Primary Outcomes (2)

• Score Respiratory Distress

  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.

  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

  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.

  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 (2)

• 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.

Study Arms (2)

Nebulized 0.9% Sodium Chloride

ACTIVE COMPARATOR

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.

Drug: 0.9% Sodium Chloride

Nebulized 3% Sodium Chloride

EXPERIMENTAL

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.

Drug: 3% Sodium Chloride

Interventions

0.9% Sodium Chloride DRUG

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.

Also known as: 0.9% saline

Nebulized 0.9% Sodium Chloride

3% Sodium Chloride DRUG

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.

Also known as: 3% saline

Nebulized 3% Sodium Chloride

Eligibility Criteria

• Age: 2 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Unidad Medica de Alta Especialidad Bajío No. 48 Hospital de Gineco - Pediatría. Instituto Mexicano del Seguro Social

León, Guanajuato, 37320, Mexico

Location

Related Publications (8)

• 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. doi: 10.1017/s1481803500012690.

  PMID: 21073773 BACKGROUND

• 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.

  PMID: 23502662 BACKGROUND

• 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.

  PMID: 22080619 BACKGROUND

• 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.

  PMID: 20646715 BACKGROUND

• 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.

  PMID: 20636429 BACKGROUND

• 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.

  PMID: 19884591 BACKGROUND

• 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.

  PMID: 19674354 BACKGROUND

• 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.

  PMID: 21352671 BACKGROUND

MeSH Terms

Conditions

Bronchiolitis; Respiratory Sounds

Interventions

Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Gloria Patricia Sosa-Bustamante
• Organization: Instituto Mexicano del Seguro Social

patriciasosab@hotmail.com

01 52 4777174800

Study Officials

• Gloria P Sosa-Bustamante, MD

  Unidad Medica de Alta Especialidad Bajio 48. Hospital de Gineco - Pediatria. Instituto Mexicano del Seguro Social

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: September 9, 2014
• Study Start: August 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 21, 2017
• Results First Posted: March 15, 2017

Record last verified: 2012-12

Data Sharing

• IPD Sharing: Will share

Locations

ME (1)