Impact Of A Health Care Protocol For Patients Suffering Symptoms Of Mild Acute Viral Bronchiolitis On Early Release In The Emergency Department

NCT01091064 | Withdrawn Phase 2 DMC

• 1 other identifier: 20636
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bronchiolitis

Outcome Measures

Primary Outcomes (1)

• emergency revisit rate

  emergency revisit rate in the first 15 days after recruitment

  15 days

Study Arms (2)

Early depart

EXPERIMENTAL

Patients who will be liberated at triage with mild acute viral bronchiolitis

Other: Randomization early depart

Medical visit group

NO INTERVENTION

Patients with acute viral bronchiolitis who will wait to be seen by the physician

Interventions

Randomization early depart OTHER

Patients will be randomized to either an early depart or for being seen by a physician.

Early depart

Eligibility Criteria

• Age: 3 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patients of any sex aged 3 to 12 months old with the diagnosis of mild acute viral bronchiolitis.

You may not qualify if:

• Infants aged \< 3 months of \> 13 months old.
• Infants born before 30 weeks gestation.
• Infants' weight \< 5 kg.
• Infants with a dehydration score of more or equal to 1.
• Yale score \> 10.
• Infants with chronic pulmonary, cardiovascular or neuromuscular disease.
• Infants with primary or secondary immunodeficiencies.
• Patients with the antecedent of wheezing.
• Need of any ventilatory support.
• Patients in whom the diagnosis of acute viral bronchiolitis is not precise.
• Patients in whose parents refuse to sign the consent formulary or not willing to participate.

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Laval University Hospital Center

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professeur

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: March 23, 2010
• Study Start: October 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2014
• Last Updated: September 7, 2015

Record last verified: 2015-09

Locations

CA (1)