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| Name | Class |
|---|---|
| Swiss Foundation for the Health of Children and Adolescents | OTHER |
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Our study will investigate inhalation therapy of NaCl 3% compared to standard therapy with no inhalation in the treatment of moderate to severe bronchiolitis. The impact on length of hospital stay will be analyzed.
Acute viral bronchiolitis is the most common lower respiratory tract infection in the first year of life and leads to a large number of hospital admissions. The only recommended treatment is supportive. However many different types of drug inhalations have been studied but their efficacy remains controversial.
Our study will compare recommended supportive therapy to supportive therapy combined to hypertonic saline (NaCl 3%) inhalations in the treatment of moderate to severe bronchiolitis. This will be the first study to use a true control group with no inhalation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NaCl 3% inhalations + standard therapy | Active Comparator | In this group, patients receive NaCl 3% inhalations ( 4ml QID) together with standard therapy. Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed. |
|
| Standard therapy | Placebo Comparator | Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NaCl 3% | Drug | NaCl 3%: 4ml QID |
|
| Measure | Description | Time Frame |
|---|---|---|
| length of hospital stay | The length of stay is defined as the time between study entry and the time at which the child reach protocol-defined discharge criteria as measured by the physician in charge. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| transfer rate to ICU | 2 years | |
| readmission rate in the next 7 days following discharge | 2 years | |
| Wang clinical severity score evolution |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Yves Pauchard | Hôpital de l'Enfance, Lausanne, Switzerland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de l'Enfance | Lausanne | Canton of Vaud | 1000 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31488402 | Derived | Jaquet-Pilloud R, Verga ME, Russo M, Gehri M, Pauchard JY. Nebulised hypertonic saline in moderate-to-severe bronchiolitis: a randomised clinical trial. Arch Dis Child. 2020 Mar;105(3):236-240. doi: 10.1136/archdischild-2019-317160. Epub 2019 Sep 5. |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard therapy | Other | Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed |
|
| 2 years |
| adverse events | 2 years |
| Patients' ability to feed | 2 years |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |