Trial record 7 of 60 for:    Open Studies | "Bronchiolitis"

Nebulized Hypertonic Saline for Bronchiolitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Hôpital Armand Trousseau.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hôpital Robert Debré
Poissy-Saint Germain Hospital
Hôpital de Versailles
Hôpital Jean Verdier
Information provided by (Responsible Party):
CARBAJAL, Hôpital Armand Trousseau
ClinicalTrials.gov Identifier:
NCT01460524
First received: October 25, 2011
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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
Bronchiolitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study on the Use of Hypertonic Saline for the Treatment of Bronchiolitis

Further study details as provided by Hôpital Armand Trousseau:

Primary Outcome Measures:
  • Hospitalization rate [ Time Frame: 6 MONTHS ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    A standardized assessment of the respiratory status will be carried out right before and after each nebulization


Estimated Enrollment: 2580
Study Start Date: November 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460524

Contacts
Contact: Ricardo Carbajal, MD, PhD +33 144736487 ricardo.carbajal@trs.aphp.fr
Contact: Emilie Courtois, RN +33 144736451 emilie.courtois@trs.aphp.fr

Locations
France
Hôpital Jean Verdier Recruiting
Bondy, Ile-de-France, France, 93143
Contact: Loïc de Ponctual, Professor    +33 148026454    loic.de-pontual@jvr.aphp.fr   
Principal Investigator: Loïc de Ponctual, MD, Professor         
Hôpital de Versailles Recruiting
Le Chesnay, France, 78157
Contact: Pierre Foucaud, MD    +33 139638944    pfoucaud@ch-versailles.fr   
Principal Investigator: Pierre Foucaud, MD         
Hôpital Armand Trousseau Recruiting
Paris, France, 75012
Contact: Ricardo Carbajal, MD, PhD    +33 144736487    ricardo.carbajal@trs.aphp.fr   
Principal Investigator: Jean-Baptiste Armengaud, MD         
Sub-Investigator: Nathalie de Suremain, MD         
Sub-Investigator: Emilie Courtois, RN         
Sub-Investigator: Emmanuel Grimprel, MD, PhD         
Sub-Investigator: Guillaume Thouvenin, MD         
Hôpital Robert Debré Recruiting
Paris, France, 75019
Contact: François Angoulvant, MD    +33 140032186    francois.angoulvant@rdb.aphp.fr   
Principal Investigator: François Angoulvant, MD         
CHI Poissy Saint Germain en Laye Recruiting
Poissy, France, 78300
Contact: Béatrice Pellegrino, MD    +33 139274050    bpellegrino@chi-poissy-st-germain.fr   
Principal Investigator: Béatrice Pellegrino, MD         
Sponsors and Collaborators
Hôpital Armand Trousseau
Hôpital Robert Debré
Poissy-Saint Germain Hospital
Hôpital de Versailles
Hôpital Jean Verdier
Investigators
Principal Investigator: Ricardo Carbajal, MD, PhD Hôpital Armand Trousseau, Paris
  More Information

No publications provided

Responsible Party: CARBAJAL, Professor of Pediatrics, Hôpital Armand Trousseau
ClinicalTrials.gov Identifier: NCT01460524     History of Changes
Other Study ID Numbers: Bronchiolitis-saline
Study First Received: October 25, 2011
Last Updated: June 29, 2012
Health Authority: France: Committee for the Protection of Personnes
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: French Data Protection Authority

Keywords provided by Hôpital Armand Trousseau:
bronchiolitis
saline
nebulization
hypertonic

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 20, 2014