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
Secondary identifying numbers N/A
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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymBREATH
Study objectivesBronchiolitis 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) studiedBronchiolitis
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Nebulized racemic epinephrine in normal saline and nebulized racemic epinephrine in 3% hypertonic saline
Primary outcome measureThe 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 measuresOxygen saturation and rate of admission to hospital.
Overall study start date14/02/2004
Completion date14/03/2005

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Weeks
Upper age limit12 Months
SexNot Specified
Target number of participants46
Key inclusion criteriaInfants 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 criteriaPre-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 enrolment14/02/2004
Date of final enrolment14/03/2005

Locations

Countries of recruitment

  • Canada

Study participating centre

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

Sponsor information

University of Alberta, Department of Pediatrics (Canada)
University/education

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

ROR logo "ROR" https://ror.org/0160cpw27

Funders

Funder type

University/education

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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