- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00677729
Hypertonic Saline to Reduce Hospital Admissions in Bronchiolitis
Inhaled Hypertonic Saline to Reduce Hospital Admissions in Infants With Viral Bronchiolitis (HS in ER Study)
Inhaled 3% hypertonic saline (HS) administered every 2-8 hours to infants admitted to hospital with viral bronchiolitis has been shown to improve airway clearance and reduces length of stay.
Hypothesis: When infants first present to the ER, frequent administration of HS over a brief time period will provide significant symptom improvement such that the need for hospital admission will be reduced.
Objective: To determine in a randomized, controlled and double-blind fashion if the short term intensive use of inhaled 3% hypertonic saline (HS) in the Emergency Room (ER) can reduce the rate of hospital admission for infants presenting with moderately severe viral bronchiolitis.
Study Overview
Status
Conditions
Detailed Description
Patients presenting to the Emergency Room (ER) or out-patient department with a diagnosis of moderately severe bronchiolitis (as defined by inclusion/exclusion criteria below) will be approached for entry into the study. After the initial routine assessment by the ER medical and nursing staff, informed consent will be obtained and the infant will be randomized to receive treatment in a double-blinded fashion with 4 ml of nebulized study solution containing 1 mg salbutamol (bronchodilator) plus either 3% hypertonic saline (HS, study group) or 0.9% saline (NS, control group) every 20 minutes for a total of 3 doses. After an observation period of 1 hour following the last dose, the infant will be reassessed by the attending physician in the ER for disposition (admit, discharge home, remain in ER for further treatment) at which point the infant's active involvement in the study will end. All subsequent therapy, if needed, will be at the sole discretion of the attending physician. The family of each recruited subject will be contacted by phone 7 days later to assess resolution of symptoms or the presence of any unexpected adverse effects.
Clinical response to the above treatment will also be determined independently by the study physician or designate utilizing a standardized respiratory scoring system, the Respiratory Distress Assessment Instrument (RDAI), at study entry and after the post-treatment observation period. The primary outcome measure is to compare the rate of admission to hospital between the study and control groups. A secondary outcome measure will involve the assessment of change in the RDAI between study entry and post-treatment.
The infant will remain in the ER throughout the study period and receive standard ongoing monitoring by the nursing staff. In the unlikely event of significant clinical worsening during this period, the ER physician on duty will be notified to assess and intervene as he/she feels appropriate. The site study investigator will be immediately notified of all such occurrences by the research assistant involved.
The study will be conducted over a single bronchiolitis season from November 1, 2008 to April 1, 2009. There will be 2 study sites as listed below with the name of the study site director.
- Royal Victoria Hospital of Barrie (Emergency Department), Barrie ON (B.A. Kuzik, MD, FRCP (lead investigator))
- Kingston General Hospital (Emergency Department) and Hotel Dieu Hospital (Emergency Department, Children's Outpatient Centre), Kingston ON (M. P. Flavin, MB, MRCP, FRCP)
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
-
Barrie, Ontario, Canada, L4M 6M2
- The Royal Victoria Hospital
-
Kingston, Ontario, Canada, K7L 2V7
- Kingston General Hospital
-
Kingston, Ontario, Canada
- Religious Hospitallers of Saint Joseph of the Hotel Dieu of Kingston
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- < 24 months.
presenting to ER or outpatient department with moderately severe viral bronchiolitis defined as:
- history of viral upper respiratory tract infection within previous 7 days, plus
- presence of wheezing and/or crackles on chest auscultation, plus
- Respiratory Distress Assessment Instrument (RDAI, appendix B) score > 4 (of 17) or transcutaneous oxygen saturation (SaO2) < 94% in room air.
Patient exclusion criteria:
- history of immunodeficiency or chronic cardiopulmonary disease (other than past history of wheezing).
- critical illness at presentation.
- use of nebulized HS within previous 12 hr.
- prematurity (gestational age < 34 weeks).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1
4 ml of nebulized study solution containing 1 mg salbutamol plus 3% hypertonic saline (NaCl)
|
4 ml of nebulized study solution containing 1 mg salbutamol plus 3% hypertonic saline every 20 minutes for a total of 3 doses
|
PLACEBO_COMPARATOR: 2
4 ml of nebulized study solution containing 1 mg salbutamol plus 0.9% saline (NaCl)
|
4 ml of nebulized study solution containing 1 mg salbutamol plus 0.9% saline (NaCl) every 20 minutes for a total of 3 doses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
compare the rate of admission to hospital between the study and control groups
Time Frame: 1 hour after treatment ends
|
1 hour after treatment ends
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in the RDAI between study entry and post-treatment.
Time Frame: 1 hour after treatment ends
|
1 hour after treatment ends
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Brian Kuzik, MD, The Royal Victoria Hospital of Barrie
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bronchial Diseases
- Lung Diseases, Obstructive
- Bronchitis
- Bronchiolitis
- Bronchiolitis, Viral
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Pharmaceutical Solutions
- Albuterol
Other Study ID Numbers
- HSERFLA
- PAED-214-08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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