Nebulized Hypertonic Saline for Bronchiolitis

Observational Study on the Use of Hypertonic Saline for the Treatment of Bronchiolitis

In randomized controlled trials, the use of nebulized hypertonic saline in acute bronchiolitis has been reported to improve respiratory distress scores, to reduce length of hospital stay and to show a trend towards lower hospitalization rates.

The investigators aim to verify by an observational study if the rate of hospital admission and the length of hospital stay of infants presenting to the emergency department (ED) with bronchiolitis decreases after the inclusion of 5.85% nebulized hypertonic saline in the treatment strategy of the ED and hospitalization wards.

The investigators will assess the evolution of hospital admission rates and the length of hospital stay in two hospitals that use 5.85% nebulized hypertonic saline for the treatment of bronchiolitis and in two hospital that do not use these nebulizations. If nebulized hypertonic saline is effective in this setting, then the hospitalization rates and length of stay should be lower during the year of hypertonic saline use compared to two previous years when this therapy was not used. These parameters would not be modified in centers that do not use hypertonic saline.

Study Overview

• Status: Completed
• Conditions: Bronchiolitis

Detailed Description

This is a before-after observational study designed to compare the results in terms of hospitalization rate and length of hospital stay between a period when nebulized hypertonic saline was included in the treatment of bronchiolitis in infants versus the two previous years when this therapy was not used in two hospitals. There will not be any randomization.

Physicians have been instructed on the use of hypertonic saline for moderate and severe bronchiolitis in infants but its totally up to them whether to use this nebulization for each particular patient. Two other hospital where nebulized hypertonic saline has never been used and will not be used during the next bronchiolitis epidemics will be the control centers.

The study comprises two periods, one prospective starting on November 2011 and ending in March 2012 and one retrospective including the two previous bronchiolitis epidemics, November 2009-March 2012 and November 2010-March 2011.

During the prospective period a standardized assessment of the respiratory status of each infant will be carried out before and after each hypertonic saline nebulization.

• Study Type: Observational
• Enrollment (Actual): 2580

Contacts and Locations

Study Locations

• France
  • Le Chesnay, France, 78157
    • Hopital de Versailles
  • Paris, France, 75019
    • Hopital Robert Debre
  • Paris, France, 75012
    • Hôpital Armand Trousseau
  • Poissy, France, 78300
    • CHI Poissy Saint Germain en Laye
  • Ile-de-France
    • Bondy, Ile-de-France, France, 93143
      • Hôpital Jean Verdier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

For the prospective part of the study, all infants up to 1 year of age presenting to the ED for bronchiolitis from November 1st, 2011 to March 30th, 2012 will be included in this observational study. For the retrospective part of the study, data of all infants up to 1 year of age who were seen in the ED for bronchiolitis from November 1st, 2009 and March 30th, 2010 and from November 1st, 2010 and March 30th, 2011 will be analyzed.

Description

Inclusion Criteria:

• All infants up to 1 year of age presenting to the ED for bronchiolitis during the study periods.

Exclusion Criteria:

• Bronchiolitis in infants older than 1 year

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization rate	Comparison of hospitalization rates of infants presenting to the ED with bronchiolitis during the year of use of nebulized hypertonic saline versus the two previous years when nebulized hypertonic saline was not used.	6 MONTHS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Comparison of lenghts of stay of infants hospitalized for bronchiolitis during the year of use of nebulized hypertonic saline in hospitalization wards versus the two previous years when nebulized hypertonic saline was not used.	6 months
Assessment of 5.85% hypertonic saline tolerance	A standardized assessment of the respiratory status will be carried out right before and after each nebulization	6 months

Collaborators and Investigators

• Sponsor: Hôpital Armand Trousseau
• Collaborators: Hopital Universitaire Robert-Debre; Versailles Hospital; Poissy-Saint Germain Hospital; Hôpital Jean Verdier
• Investigators: Principal Investigator: Ricardo Carbajal, MD, PhD, Hôpital Armand Trousseau, Paris

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: October 25, 2011
• First Submitted That Met QC Criteria: October 26, 2011
• First Posted (Estimate): October 27, 2011

Study Record Updates

• Last Update Posted (Estimate): June 24, 2015
• Last Update Submitted That Met QC Criteria: June 23, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: nebulization; bronchiolitis; saline; hypertonic
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: Bronchiolitis-saline