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Clinical Trial Summary

Acute viral bronchiolitis is the principal cause of lower respiratory tract infection in infants worldwide. It is characterized by a first episode of respiratory distress preceded by rhinorrhea, cough and fever. The majority of patients present with mild symptoms which can be treated safely at home by parents. Every year between October thru April emergency departments in North America are overwhelmed with patients waiting to be seen with mild respiratory infections, such as bronchiolitis. Thus new strategies in health care have to be elaborated to reduce costs and waiting time in the emergency department.

The investigators hypothesize that patients liberated from triage with mild acute viral bronchiolitis would have the same rate of office re-visits than those with mild acute bronchiolitis in the emergency department.


Clinical Trial Description

Acute viral bronchiolitis constitutes the principal cause of acute lower respiratory tract infections in infants and children in Nord America. Every year 11% of infants younger than 1 year and 6% of those between 1 and 2 years are affected. Acute viral bronchiolitis is characterized by a first episode of respiratory distress associated to rhinorrhea, cough and fever, other symptoms such as vomiting, use of accessory intercostal muscles and irritability can be present. Mild symptoms presentation in bronchiolitis is very common, these patients do not require treatment or testing, only appropriate information on how to ameliorate respiratory symptoms and a well list of alarm signs for parents are frequently enough to send the patient home.

Increasing workload in the ED is a national worry after the last 20 years. Between October and April, this phenomena is seen each year due to cold and influenza season. From an economic perspective along with a lack in human resources, new strategies have to be implemented to reduce duration and costs in office visits in the emergency department. Since mild bronchiolitis does not require a specific treatment, we hypothesize that patients liberated from triage with mild acute viral bronchiolitis would have the same rate of office re-visits than those with mild acute bronchiolitis in the emergency department.

Our principal objective will be to compare between groups of infants with mild acute viral bronchiolitis the use of hospital resources within the fist 15 days after recruitment. Specific objectives will be to compare between the 2 groups the rate of office re-visit, or to the ED during the fist 15 days after recruitment, the severity of respiratory symptoms during re-visits, on follow up at 2-4 days, 6-8 days and 13-15 days, patient and parent satisfaction of the first visit and of follow up at 2-4 days, 6-8 days and 13-15 days.

This research project will have a rapid and direct effect on quality of health care in infants with acute viral bronchiolitis and their parents, as well as important repercussions on the workload in the waiting rooms of EDs allowing physicians to concentrate on other patients are in need of a rapid attention. This project will be carried on in two high concentration specialized hospitals in the province of Quebec, Canada. ;


Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label


Related Conditions & MeSH terms


NCT number NCT01091064
Study type Interventional
Source Laval University
Contact
Status Withdrawn
Phase Phase 2
Start date October 2011
Completion date April 2014

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