|
|
|
|
|
Sponsors and Collaborators: |
Laval University Canadian Institutes of Health Research (CIHR) Centre de Recheche du Centre Hospitalier Université Laval |
Information provided by: | Laval University |
ClinicalTrials.gov Identifier: | NCT00729274 |
The purpose of this study is to compare the efficacy of nebulized hypertonic saline solution with or without epinephrine to reduce hospitalization rate in infants less than 18 months of age with acute viral bronchiolitis. We hypothesize that epinephrine or hypertonic saline solution will become an effective treatment for bronchiolitis and that together they could reduce Hospitalization rate.
Condition | Intervention |
Acute Viral Bronchiolitis. |
Drug: Adrenalin 0.1% Drug: Hypertonic Saline Solution 3% |
ChemIDplus related topics: | Sodium chloride Epinephrine Epinephrine bitartrate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Factorial Assignment, Safety/Efficacy Study |
Official Title: | Factorial Analysis of Epinephrine and Hypertonic Saline Efficacy to Reduce Hospitalization Rate in Infants Less Than 18 Months With Acute Viral Bronchiolitis: A Randomized Double Blind Clinical Essay. |
Estimated Enrollment: | 700 |
Study Start Date: | October 2009 |
Estimated Study Completion Date: | April 2012 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Epinephrine Nebulization (adrenaline 0.1%) 0.5ml/kg/dose, (max. 5ml) mixed with Hypertonic Saline solution 3%.
|
Drug: Adrenalin 0.1%
0.5ml/kg/dose, (max. 5ml)
Drug: Hypertonic Saline Solution 3%
0.5ml/kg/dose. 23.4% Hypertonic Saline Solution will be diluted to render 3% Hypertonic Saline Solution.
|
2: Active Comparator
Nebulisation of Epinephrine (adrenalin 0.1%) mixed with saline 0.9% solution.
|
Drug: Adrenalin 0.1%
0.5ml/kg/dose, (max. 5ml)
Drug: Hypertonic Saline Solution 3%
0.5ml/kg/dose. 23.4% Hypertonic Saline Solution will be diluted to render 3% Hypertonic Saline Solution.
|
3: Active Comparator
Hypertonic Saline 3% solution alone.
|
Drug: Adrenalin 0.1%
0.5ml/kg/dose, (max. 5ml)
Drug: Hypertonic Saline Solution 3%
0.5ml/kg/dose. 23.4% Hypertonic Saline Solution will be diluted to render 3% Hypertonic Saline Solution.
|
4: Placebo Comparator
Saline solution 0.9% Nebulization
|
Drug: Adrenalin 0.1%
0.5ml/kg/dose, (max. 5ml)
Drug: Hypertonic Saline Solution 3%
0.5ml/kg/dose. 23.4% Hypertonic Saline Solution will be diluted to render 3% Hypertonic Saline Solution.
|
Acute Viral Bronchiolitis (AVB) is the principal infectious disease of the lower respiratory track in infants worldwide. It affects 20% of Noth-American infants every winter season, 6.2% require treatment in the ER and between 3 to 5% of them require hospitalization or ICU stay. Although the mortality rate has remained constant in the passed 10 years, the incidence in North-America has increased by a factor of 3.
AVB is clinically characterized by an episode of difficult breathing, increase of respiratory work, presence of wheezing, crackles, signs of upper respiratory track infection, and fever (Rectal temperature >38DC). The currently accepted treatment (Adequate hydration, supplementary oxygen and cleaning of upper respiratory secretions) remains as non-controversial, even though many research studies have tried to prove the efficacy of other substances. Epinephrine and Hypertonic saline have shown to be potentially effective treatments for AVB.
We are proposing a multicenter randomized double blind clinical essay, in patients who will assist to the emergency department of 5 Hospital Centers in Quebec Canada, between October 2009 thru April 2012, and are diagnosed with AVB by the following criteria (first moderate episode of sudden difficulty to breathe and signs and symptoms of upper respiratory track infection plus fever). Patients will be separated into 4 groups: Nebulized epinephrine and hypertonic saline solution (NaCl 3%), Nebulized epinephrine and Physiologic Saline solution (NaCl 0.9%),Nebulized hypertonic saline solution (NaCl 3%),and nebulized physiologic saline solution (NaCl 0.9%). Each group will receive a treatment of 3 nebulizations in the fist 4 hours of ER stay and their respiratory distress signs will be measured using various clinical scores.
The principal objective is to compare the efficacy of different groups of treatment for reducing hospitalization rate. And our secondary principal objective is to compare between groups of treatment the intensity of symptoms measured by the Infant Respiratory Assessment Score, which has been validated.
We will also measure time from discharge of the ER. The presence of secondary effects. The rate of transfers from ER to Pediatric Intensive Care Unit. The intensity of symptoms 7 days after treatment. The number of times the patient comes back seeking medical care within the first 28 days of their first episode of AVB, and hospitalization rate of recurrent patients.
The evaluation of the efficacity of epinephrine or hypertonic saline, in the treatment of AVB, is very important in order to improve the respiratory condition in our patients. To avoid unnecessary hospitalizations and thus improve the quality of life of the patient, and that of their parents; optimizing at the same time hospital resources.
Ages Eligible for Study: | up to 18 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dr. Guimont Chantal, MD, PhD | (418) 656-4141 ext 70554 | chantal.guimont@crchul.ulaval.ca |
Contact: Dr. Aguirre Emilio, MD | (418) 656-4141 ext 72202 | emilio.aguirre@crchul.ulaval.ca |
Canada | |||||
Hospital Center Laval University | Not yet recruiting | ||||
Quebec, Canada, G1V 4G2 | |||||
Contact: Bouchard Julie, Research Nurse. (418) 656-4141 ext 70542 julie.bouchard@crchul.ulaval.ca | |||||
Contact: Aguirre Emilio, MD (418) 656-4141 ext 70542 emilio.aguirre@crchul.ulaval.ca |
Laval University |
Canadian Institutes of Health Research (CIHR) |
Centre de Recheche du Centre Hospitalier Université Laval |
Principal Investigator: | Guimont Chantal, MD, PhD. | Hospital Center Laval University of Quebec, Canada. |
Responsible Party: | Pediatric Unit Research Center of Laval University's Hospital. ( Dre. Chantal Guimont MD, PhD. FRSQ. ) |
Study ID Numbers: | 190608, 110.05.01 |
First Received: | August 5, 2008 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00729274 |
Health Authority: | Canada: Canadian Institutes of Health Research |
|
|
|
|