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Hypertonic Saline to Reduce Hospital Admissions in Bronchiolitis

This study has been completed.
Sponsor:
Collaborators:
Kingston General Hospital
Religious Hospitallers of Saint Joseph of the Hotel Dieu of Kingston
Royal Victoria Hospital Of Barrie
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00677729
First received: May 2, 2008
Last updated: November 2, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Viral Bronchiolitis
Drug: solution contains 1 mg salbutamol plus 3% hypertonic saline
Drug: solution contains 1 mg salbutamol plus 0.9% saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Inhaled Hypertonic Saline to Reduce Hospital Admissions in Infants With Viral Bronchiolitis (HS in ER Study)

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • compare the rate of admission to hospital between the study and control groups [ Time Frame: 1 hour after treatment ends ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in the RDAI between study entry and post-treatment. [ Time Frame: 1 hour after treatment ends ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: November 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
4 ml of nebulized study solution containing 1 mg salbutamol plus 3% hypertonic saline (NaCl)
Drug: solution contains 1 mg salbutamol plus 3% hypertonic saline
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)
Drug: solution contains 1 mg salbutamol plus 0.9% saline
4 ml of nebulized study solution containing 1 mg salbutamol plus 0.9% saline (NaCl) every 20 minutes for a total of 3 doses

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)
  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. < 24 months.
  2. presenting to ER or outpatient department with moderately severe viral bronchiolitis defined as:

    1. history of viral upper respiratory tract infection within previous 7 days, plus
    2. presence of wheezing and/or crackles on chest auscultation, plus
    3. Respiratory Distress Assessment Instrument (RDAI, appendix B) score > 4 (of 17) or transcutaneous oxygen saturation (SaO2) < 94% in room air.

Patient exclusion criteria:

  1. history of immunodeficiency or chronic cardiopulmonary disease (other than past history of wheezing).
  2. critical illness at presentation.
  3. use of nebulized HS within previous 12 hr.
  4. prematurity (gestational age < 34 weeks).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677729

Locations
Canada, Ontario
The Royal Victoria Hospital
Barrie, Ontario, Canada, L4M 6M2
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Religious Hospitallers of Saint Joseph of the Hotel Dieu of Kingston
Kingston, Ontario, Canada
Sponsors and Collaborators
Queen's University
Kingston General Hospital
Religious Hospitallers of Saint Joseph of the Hotel Dieu of Kingston
Royal Victoria Hospital Of Barrie
Investigators
Principal Investigator: Brian Kuzik, MD The Royal Victoria Hospital of Barrie
  More Information

No publications provided by Queen's University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian Kuzik, Royal Victoria Hospital of Barrie, Ontario
ClinicalTrials.gov Identifier: NCT00677729     History of Changes
Other Study ID Numbers: HSERFLA, PAED-214-08
Study First Received: May 2, 2008
Last Updated: November 2, 2010
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
bronchiolitis
hypertonic saline
infants

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis, Viral
Bronchial Diseases
Bronchitis
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Albuterol
Pharmaceutical Solutions
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on November 25, 2014