Condition category
Respiratory
Date applied
01/09/2005
Date assigned
13/09/2005
Last edited
16/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Simran Grewal

ORCID ID

Contact details

2nd Floor
Rm 7217B
Aberhart Centre 1
Edmonton
AB
T6G 2J3
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

BREATH

Study hypothesis

Bronchiolitis which is the most common lower respiratory tract infection under the age of one. Symptoms can range from mild to severe and include fever, rhinorrhea, cough, and dyspnea.

Compared to nebulized racemic epinephrine in normal saline, patients with acute bronchiolitis in the emergency department treated with nebulized racemic epinephrine in 3% hypertonic saline will have a statistically significant improvement in their Respiratory Assessment Change Score (RACS).

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Bronchiolitis

Intervention

Patients who entered the study were randomized to receive either nebulized epinephrine in hypertonic saline or nebulized epinephrine in normal saline. Each patient had his or her oxygen saturation level, heart rate, respiratory rate and Respiratory Distress Assessment Instrument (RDAI) score measured at baseline and then again at 30, 60, 90 and 120 minutes. The nurses, physicians and study team personnel remained blinded throughout the study. There were no invasive procedures involved.

Intervention type

Drug

Phase

Not Specified

Drug names

Nebulized racemic epinephrine in normal saline and nebulized racemic epinephrine in 3% hypertonic saline

Primary outcome measures

The Respiratory Assessment Change Score (RACS) was the primary outcome variable of the study. This score is a clinical scoring system based on the Respiratory Distress Assessment Index (RDAI) and the respiratory rate.

Secondary outcome measures

Oxygen saturation and rate of admission to hospital.

Overall trial start date

14/02/2004

Overall trial end date

14/03/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Infants 6 weeks to 12 months of age with clinical symptoms of a viral respiratory infection (coryza or temperature ≥ 38.0°C), first episode of wheezing, oxygen saturation ≥ 85% but ≤ 96%, and initial Respiratory Distress Assessment Instrument (RDAI) score ≥ 4.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

46

Participant exclusion criteria

Pre-existing cardiac or pulmonary disease, previous diagnosis of asthma by a physician, any previous use of bronchodilators, severe disease requiring resuscitation room care, inability to administer medication by nebulizer, inability to obtain informed consent secondary to a language barrier, or no phone access for follow-up.

Recruitment start date

14/02/2004

Recruitment end date

14/03/2005

Locations

Countries of recruitment

Canada

Trial participating centre

2nd Floor, Rm 7217B
Edmonton, AB
T6G 2J3
Canada

Sponsor information

Organisation

University of Alberta, Department of Pediatrics (Canada)

Sponsor details

8213 Aberhart Centre 1
11402 University Avenue
Edmonton
AB
T6G 2J3
Canada

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Department of Pediatrics, University of Alberta, Edmonton, Alberta (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19884591

Publication citations

  1. Results

    Grewal S, Ali S, McConnell DW, Vandermeer B, Klassen TP, A randomized trial of nebulized 3% hypertonic saline with epinephrine in the treatment of acute bronchiolitis in the emergency department., Arch Pediatr Adolesc Med, 2009, 163, 11, 1007-1012, doi: 10.1001/archpediatrics.2009.196.

Additional files

Editorial Notes