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This study evaluates the effectiveness of nebulized 3% hypertonic saline solution with salbutamol in the treatment of children under 2 years, hospitalised for acute viral bronchiolitis. Half of the participants will receive nebulized 3% hypertonic saline solution with salbutamol three times daily, the other half will receive standard supportive care, which is the cornerstone of the bronchiolitis management.
Acute viral bronchiolitis is the most common lower respiratory tract infection in infants up to two years old. Currently there is no effective treatment so standard treatment remains supportive care with supplemental oxygen to correct hypoxia, minimal handling to minimise the risk of exhaustion and the provision of fluids.
In recent years some studies have suggested that nebulised hypertonic saline, which improve airway hygiene, may influence the course of the illness and reduce the duration of hospitalisation without significant side effects.
Study protocol: half of the included patients will receive standard treatment for bronchiolitis, which includes only supportive care, the other half will additionally receive nebulized 3% hypertonic saline solution with salbutamol (to avoid potential bronchial obstruction) three times daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypertonic saline | Experimental | 4 ml of nebulized 3 % hypertonic saline + salbutamol 0,03 ml/kg every 8 hours for the time of hospitalisation and standard supportive care (oxygen to correct hypoxia, minimal handling to minimise the risk of exhaustion, provision of fluids, gentle nasal aspiration) |
|
| supportive care | No Intervention | Standard supportive care (oxygen to correct hypoxia, minimal handling to minimise the risk of exhaustion, provision of fluids, gentle nasal aspiration) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nebulized 3% hypertonic solution | Drug | already described |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fit to discharge time | Fit to discharge time: as the point (measured in hours) at which the infant was feeding adequately (taking >75% of their usual intake) and had been in air with a saturation of at least 92% for 6 h. | Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospitalisation | Actual time to discharge in hours, which could be prolonged for other reasons than just bronchiolitis | Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years |
| Duration of hypoxia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tatjana Lejko Zupanc, MD, PhD | University Medical Centre Ljubljana | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of infectious disease, University Medical Centre, Ljubljana | Ljubljana | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23900970 | Result | Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulised hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2013 Jul 31;(7):CD006458. doi: 10.1002/14651858.CD006458.pub3. | |
| 25389139 | Result | Everard ML, Hind D, Ugonna K, Freeman J, Bradburn M, Cooper CL, Cross E, Maguire C, Cantrill H, Alexander J, McNamara PS; SABRE Study Team. SABRE: a multicentre randomised control trial of nebulised hypertonic saline in infants hospitalised with acute bronchiolitis. Thorax. 2014 Dec;69(12):1105-12. doi: 10.1136/thoraxjnl-2014-205953. |
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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 |
|---|---|
| D006982 | Hypertonic Solutions |
| ID | Term |
|---|---|
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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For how long (in hours) participants need the oxygen therapy (have saturation on air bellow 92%). |
| Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years |
| Clinical severity score (CSS) assessed by Wang score | Wang 1992 CSS as an outcome: measured two times daily | Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time |
| Number of participants with treatment related adverse events assessed by questionnaire | To asses all possible side effects related to the inhalation of hypertonic saline | Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time |
| Number of participants transferred to the intensive care unit (ICU) | The need to be transferred to the ICU because of the respiratory failure | Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time |
| Number of patients readmitted to the hospital because of the same diagnose | Rate of readmission within one month after discharge because of the same disease | Through study completion - estimated to 2 years; the patients will be assessed up to one month after discharge |
| Comparison of fit to discharge time between patients treated with nebulized hypertonic saline with respiratory syncytial virus (RSV) versus non-RSV bronchiolitis. | To see if there are any differences in fit to discharge time (the point measured in hours at which the infant was feeding adequately - taking >75% of their usual intake and had been in air with a saturation of at least 92% for 6 h) between patients who received nebulized hypertonic saline and have RSV bronchiolitis and patients who received nebulized hypertonic saline and have non-RSV bronchiolitis (to see if hypertonic saline has better effect on fit to discharge time in patients who have RSV bronchiolitis compared to patients who have non-RSV bronchiolitis). | Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years |
| Comparison of hypoxia duration between patients treated with nebulized hypertonic saline with respiratory syncytial virus (RSV) versus non-RSV bronchiolitis. | To see if there are any differences in hypoxia (for how long in hours participants need the oxygen therapy: have saturation bellow 92%) between patients who received nebulized hypertonic saline and have RSV bronchiolitis and patients who received nebulized hypertonic saline and have non-RSV bronchiolitis. | Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years |
| Number of participants with treatment related adverse events assessed by questionnaire: comparison of patients with RSV bronchiolitis and patients with non-RSV bronchiolitis. | To asses all possible side effects related to the inhalation of hypertonic saline in patients who have RSV bronchiolitis compared to the patients who have non-RSV bronchiolitis. | through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time |
| 26416925 | Result | Zhang L, Mendoza-Sassi RA, Klassen TP, Wainwright C. Nebulized Hypertonic Saline for Acute Bronchiolitis: A Systematic Review. Pediatrics. 2015 Oct;136(4):687-701. doi: 10.1542/peds.2015-1914. |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |