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
Scientific
2nd Floor, Rm 7217B
Aberhart Centre 1
Edmonton, AB
T6G 2J3
Canada
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| 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 | 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 study start date | 14/02/2004 |
| 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 number of participants | 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
T6G 2J3
Canada
Sponsor information
University of Alberta, Department of Pediatrics (Canada)
University/education
University/education
8213 Aberhart Centre 1
11402 University Avenue
Edmonton, AB
T6G 2J3
Canada
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
