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| ID | Type | Description | Link |
|---|---|---|---|
| HSTWICS | Other Identifier | Queen's Department of Pediatrics |
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Funding declined. Study never initiated.
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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.
the brief summary captures the essence of the study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypertonic saline | Experimental | inhalation of 4 ml nebulized study solution containing 3% hypertonic saline (HS, study group). Each dose of study solution will also contain a standard dose of bronchodilator (salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) 1,2 added by the ED staff. Initial therapy will consist of 3 consecutive nebulizations given in rapid succession (back-to-back, approximately every 20 minutes). |
|
| saline | Active Comparator | inhalation of 4 ml nebulized study solution containing saline 0.9% saline (NS, control group). Each dose of study solution will also contain a standard dose of bronchodilator (salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) 1,2 added by the ED staff. Initial therapy will consist of 3 consecutive nebulizations given in rapid succession (back-to-back, approximately every 20 minutes). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypertonic saline | Other | inhaled nebulized 3%NaCl |
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| Measure | Description | Time Frame |
|---|---|---|
| Rates of admission to hospital | Rates of admission to hospital | duration of hospital ER stay, an average of 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in respiratory distress scores after initial protocol treatment in the ED | 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 |
| Length-of-stay in the ED in the subgroup of patients not admitted |
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Inclusion Criteria:
Exclusion Criteria:
History of immunodeficiency, chronic cardiopulmonary disease (other than past history of wheezing), Down syndrome, gestational age under 34 weeks.
Severe illness at presentation as defined by any of the following
Use of nebulized HS within previous 12 hours
Presence of active varicella infection.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Flavin | Queen's University | Principal Investigator |
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| ID | Term |
|---|---|
| D012135 | Respiratory Sounds |
| D001249 | Asthma |
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
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| saline | Other | inhaled nebulized 0.9% NaCl |
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Length-of-stay in the ED in the subgroup of patients not admitted |
| an average of 6 hours |
| Cumulative dose of bronchodilator administered in ED prior to admission/discharge order | Cumulative dose of bronchodilator administered in ED prior to admission/discharge order | an average of 6 hours |
| Length of hospital stay in the those who are admitted | Length of hospital stay in the those who are admitted | length of hospital stay, an average of 3 days |
| Rate of return visit to ED (for respiratory illness) within 14 days of enrollment | Rate of return visit to ED (for respiratory illness) within 14 days of enrollment | 14 days |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D006851 |
| Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |