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NCT01460524 Clinical Trial

Nebulized Hypertonic Saline for Bronchiolitis

Bronchiolitis Clinical Trial

Official title:
Observational Study on the Use of Hypertonic Saline for the Treatment of Bronchiolitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01460524
Other study ID # Bronchiolitis-saline
Secondary ID
Status Completed
Phase N/A
First received October 25, 2011
Last updated June 23, 2015
Start date November 2011
Est. completion date May 2013

Study information
Verified date June 2015
Source Hôpital Armand Trousseau
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of PersonnesFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: French Data Protection Authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 2580
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 1 Year
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Hôpital Jean Verdier Bondy Ile-de-France
France Hôpital de Versailles Le Chesnay
France Hôpital Armand Trousseau Paris
France Hôpital Robert Debré Paris
France CHI Poissy Saint Germain en Laye Poissy

Sponsors (5)
Lead Sponsor Collaborator
Hôpital Armand Trousseau Hôpital de Versailles, Hôpital Jean Verdier, Poissy-Saint Germain Hospital, Robert Debré Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 Yes
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