A comparison of nebulized 3% hypertonic saline and epinephrine versus nebulized normal saline and epinephrine in the treatment of acute bronchiolitis

ISRCTN	ISRCTN66632312
DOI	https://doi.org/10.1186/ISRCTN66632312
Protocol serial number	N/A
Sponsor	University of Alberta, Department of Pediatrics (Canada)
Funder	Department of Pediatrics, University of Alberta, Edmonton, Alberta (Canada)

Submission date: 01/09/2005
Registration date: 13/09/2005
Last edited: 16/11/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Simran Grewal
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	BREATH
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Nebulized racemic epinephrine in normal saline and nebulized racemic epinephrine in 3% hypertonic saline
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Oxygen saturation and rate of admission to hospital.
Completion date	14/03/2005

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Weeks
Upper age limit	12 Months
Sex	Not Specified
Target sample size at registration	46
Key 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.
Key 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.
Date of first enrolment	14/02/2004
Date of final enrolment	14/03/2005

Locations

Countries of recruitment

Canada

Study participating centre

2nd Floor, Rm 7217B

Edmonton, AB
T6G 2J3
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2009		Yes	No