Clinical Trial: Efficacy of 3% Hypertonic Saline in Acute Viral Bronchiolitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 3% Hypertonic Saline to Reduce Hospitalization Rate in Acute Viral Bronchiolitis: a Randomized Double Blind Clinical Trial
Brief Summary: The purpose of this study is to determine whether nebulized hypertonic saline solution reduces the admission rate 48 hours after initial treatment in the emergency department, when compared to normal saline solution (control).
Detailed Summary:
Acute viral bronchiolitis remains a significant cause of hospitalization and to date, no treatment reduce the rate of hospitalization. The only accepted treatment for bronchiolitis is nasal cleaning, hydration and for hospitalized hypoxemic infants, oxygen administration.
Several studies shown that nebulization of hypertonic saline solution reduce length of stay in hospital for hospitalized infant but effect on rate of hospitalization remains unclear.
The investigators propose a randomized double blind multicenter clinical trial on infants 6 weeks to 12 months old with moderate or severe bronchiolitis, in 21 emergency departments of hospitals situated France, during 2 winter seasons.
The investigators hypothesize that infants with bronchiolitis treated with nebulized hypertonic 3% saline solution would have less risk of being hospitalized. Our principal objective is to determine if nebulized 3% hypertonic saline solution reduces admission rate 24 hours after treatment compared to placebo.
Secondary objectives are to compare between groups intensity of respiratory symptoms measured by RDAI clinical score, duration of symptoms, length of hospital stay for hospitalized infants, adverse effects and health care utilization.
Patients presenting to the Emergency Department with a diagnosis of moderately severe bronchiolitis will be approached for entry into the study. After the initial routine assessment, informed consent will be obtained and the infant will be randomized to receive treatment in a double-blinded fashion 4 ml of nebulized study solution either 3% hypertonic saline (HS, study group) or 0.9% saline (NS, control group) every 20 minutes for a total of 2 doses. After an o
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: Admission rate [ Time Frame: 24 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- change in RDAI score [ Time Frame: 2 hours ]
- Number of Participants with Adverse Events [ Time Frame: 2 hours ]
- length of hospitalization for hospitalized infant [ Time Frame: 1 month ]
- health care utilisation [ Time Frame: 1 month ]
Original Secondary Outcome: Same as current
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: November 14, 2012
Date Started: October 2012
Date Completion:
Last Updated: July 25, 2014
Last Verified: July 2014
