Nebulized Hypertonic Saline for Bronchiolitis

NCT01460524 | Completed

• 1 other identifier: Bronchiolitis-saline
• Study Type: observational
• Target: 2,580
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Bronchiolitis

Keywords

bronchiolitis; saline; nebulization; hypertonic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Length of hospital stay

  6 months

• Assessment of 5.85% hypertonic saline tolerance

  6 months

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• Bronchiolitis in infants older than 1 year

Sponsors & Collaborators

• Hôpital Armand Trousseau: lead
• Hopital Universitaire Robert-Debre: collaborator
• Poissy-Saint Germain Hospital: collaborator
• Versailles Hospital: collaborator
• Hôpital Jean Verdier: collaborator

Study Sites (5)

Hôpital de Versailles

Le Chesnay, 78157, France

Location

Hôpital Armand Trousseau

Paris, 75012, France

Location

Hôpital Robert Debré

Paris, 75019, France

Location

CHI Poissy Saint Germain en Laye

Poissy, 78300, France

Location

Hôpital Jean Verdier

Bondy, Île-de-France Region, 93143, France

Location

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Ricardo Carbajal, MD, PhD

  Hôpital Armand Trousseau, Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: October 27, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

FR (5)