Nebulized Hypertonic Saline for Bronchiolitis

Sponsor

Hôpital Armand Trousseau (Other)

Overall Status

Completed

CT.gov ID

NCT01460524

Collaborator

Hopital Universitaire Robert-Debre (Other), Poissy-Saint Germain Hospital (Other), Versailles Hospital (Other), Hôpital Jean Verdier (Other)

2,580

Enrollment

Locations

Duration (Months)

516

Patients Per Site

28.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

2580 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Outcome Measures

Primary Outcome Measures

Hospitalization rate [6 MONTHS]
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.

Secondary Outcome Measures

Length of hospital stay [6 months]
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.
Assessment of 5.85% hypertonic saline tolerance [6 months]
A standardized assessment of the respiratory status will be carried out right before and after each nebulization

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 1 Year

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Jean Verdier	Bondy	Ile-de-France	France	93143
2	Hôpital de Versailles	Le Chesnay		France	78157
3	Hôpital Armand Trousseau	Paris		France	75012
4	Hôpital Robert Debré	Paris		France	75019
5	CHI Poissy Saint Germain en Laye	Poissy		France	78300