Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2580 participants
OBSERVATIONAL
2011-11-30
2013-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Day
1 Year
ALL
No
Sponsors
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Hopital Universitaire Robert-Debre
OTHER
Poissy-Saint Germain Hospital
OTHER
Versailles Hospital
OTHER
Hôpital Jean Verdier
OTHER
Hôpital Armand Trousseau
OTHER
Responsible Party
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CARBAJAL
Professor of Pediatrics
Principal Investigators
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Ricardo Carbajal, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Armand Trousseau, Paris
Locations
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Hôpital de Versailles
Le Chesnay, , France
Hôpital Armand Trousseau
Paris, , France
Hôpital Robert Debré
Paris, , France
CHI Poissy Saint Germain en Laye
Poissy, , France
Hôpital Jean Verdier
Bondy, Île-de-France Region, France
Countries
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Other Identifiers
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Bronchiolitis-saline
Identifier Type: -
Identifier Source: org_study_id
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