Wheeze
Conditions
Keywords
wheeze, early childhood, asthma, bronchiolitis, infection triggered
Brief summary
Hypothesis: substitution of nebulized 3% NaCl (HS) for the standard normal saline (NS) used in bronchodilator therapy for acute viral wheezing in all children under age 6 years will provide superior symptom relief leading to decreased admission rates from the Emergency Department. The study will test the efficacy of frequent doses of inhaled bronchodilator co-administered with either 3% hypertonic saline (HS, study group) or 0.9% normal saline (NS, control group) in a prospective, double blind, randomized controlled, multi-centre clinical trial of children under age 6 years presenting to the ED with acute viral-associated wheezing.
Detailed description
the brief summary captures the essence of the study
Interventions
OTHERhypertonic saline
inhaled nebulized 3%NaCl
OTHERsaline
inhaled nebulized 0.9% NaCl
Sponsors
Dr. Michael Flavin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Days to 6 Years
Healthy volunteers
No
Inclusion criteria
1. Age under 6 years 2. History of viral upper respiratory infection within previous 7 days 3. Wheezing or crackles detected on chest auscultation 4. Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater or oxygen saturation (SaO2) of 94% or less in room air.
Exclusion criteria
1. History of immunodeficiency, chronic cardiopulmonary disease (other than past history of wheezing), Down syndrome, gestational age under 34 weeks. 2. Severe illness at presentation as defined by any of the following * respiratory rate greater than 80/min * SaO2 less than 88% in room air * need for assisted ventilation 3. Use of nebulized HS within previous 12 hours 4. Presence of active varicella infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of admission to hospital | duration of hospital ER stay, an average of 4 hours | Rates of admission to hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in respiratory distress scores after initial protocol treatment in the ED | time from pre-intervention assessment to post-intervention assessment, an average of 2 hours | Improvement in respiratory distress scores after initial protocol treatment in the ED |
| Length-of-stay in the ED in the subgroup of patients not admitted | an average of 6 hours | Length-of-stay in the ED in the subgroup of patients not admitted |
| Cumulative dose of bronchodilator administered in ED prior to admission/discharge order | an average of 6 hours | Cumulative dose of bronchodilator administered in ED prior to admission/discharge order |
| Length of hospital stay in the those who are admitted | length of hospital stay, an average of 3 days | Length of hospital stay in the those who are admitted |
| Rate of return visit to ED (for respiratory illness) within 14 days of enrollment | 14 days | Rate of return visit to ED (for respiratory illness) within 14 days of enrollment |
Outcome results
None listed