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NCT Number: NCT01460524

Nebulized Hypertonic Saline for Bronchiolitis

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.

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Key information

Conditions

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

Age range

1 day–1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Jean Verdier, Bondy, Île-de-France Region, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Hospitalization rate

    Time frame: 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 outcomes

  1. Length of hospital stay

    Time frame: 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.

  2. Assessment of 5.85% hypertonic saline tolerance

    Time frame: 6 months

    A standardized assessment of the respiratory status will be carried out right before and after each nebulization

Sponsors and collaborators

Lead sponsor

Hôpital Armand Trousseau

Other

Collaborators

  • Hopital Universitaire Robert-Debre
  • Hôpital Jean Verdier
  • Poissy-Saint Germain Hospital
  • Versailles Hospital

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 27, 2011
Registry last updated
Jun 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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