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Nebulized Epinephrine or Hypertonic Saline for the Treatment of Acute Bronchiolitis (NEHSTAB)

This study is not yet open for participant recruitment.
Verified by Laval University, August 2008

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
  Purpose

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   

U.S. FDA Resources

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.

Further study details as provided by Laval University:

Primary Outcome Measures:
  • Hospitalization Rate [ Time Frame: After two treatments in the emergency department ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The IRAS (Infant Respiratory Assessment Score) will be measured after each Treatment to verify improvement. [ Time Frame: 30,60,90 and 120 min ] [ Designated as safety issue: No ]

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.

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   up to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • clinical diagnosis of viral bronchiolitis
  • Age 0 to 18 months
  • Clinical Score IRAS >3 and <8

Exclusion Criteria:

  • prematurity <30 weeks
  • chronic lung disease
  • immunosuppression.
  • History of wheezing or asthma.
  • Clinical Score IRAS >9
  • parents refuse study
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729274

Contacts
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    

Locations
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    

Sponsors and Collaborators
Laval University
Canadian Institutes of Health Research (CIHR)
Centre de Recheche du Centre Hospitalier Université Laval

Investigators
Principal Investigator:     Guimont Chantal, MD, PhD.     Hospital Center Laval University of Quebec, Canada.    
  More Information


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

Study placed in the following topic categories:
Virus Diseases
Bronchiolitis, Viral
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Bronchiolitis
Bronchitis
Epinephrine

Additional relevant MeSH terms:
Respiratory System Agents
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Adrenergic Agents
Sympathomimetics
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cardiovascular Agents
Pharmacologic Actions
Adrenergic Agonists
Mydriatics
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on September 22, 2008




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