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The purpose of this study is to evaluate the efficacy of hypertonic saline vs. normal saline in the treatment of infants hospitalized for bronchiolitis, regarding length of hospital stay, oxygen requirements and clinical outcome.
Despite bronchiolitis is a very frequent disease among infants, there are still controversies regarding its treatment. Hypertonic saline has been proposed as useful treatment in these children, bur information is still controversial.
The aim is to asses that using Nebulized Hypertonic Saline with bronchodilators (albuterol) may reduce the days of hospitalization and improve clinical outcomes in patients with acute bronchiolitis, compared with using Normal Saline with albuterol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertonic | Experimental | Nebulized hypertonic saline (sodium chloride 3%) + albuterol |
|
| Normal | Active Comparator | Normal saline (sodium chloride 0.9%) + albuterol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypertonic saline | Drug | 3 cc nebulized hypertonic saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization Days | hospitalization days | Participants will be followed for the duration of hospitalization, an expected average of 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Oxygen Use | Length of oxygen use (days) | Participants will be followed for the duration of hospitalization, an expected average of 4 days |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria I Espelt, MD | Hospital General de Niños Pedro de Elizalde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Niños Pedro de Elizalde | Buenos Aires | Buenos Aires F.D. | C1270AAN | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18843717 | Background | Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulized hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006458. doi: 10.1002/14651858.CD006458.pub2. | |
| 20713480 | Background | Ralston S, Hill V, Martinez M. Nebulized hypertonic saline without adjunctive bronchodilators for children with bronchiolitis. Pediatrics. 2010 Sep;126(3):e520-5. doi: 10.1542/peds.2009-3105. Epub 2010 Aug 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypertonic | Hypertonic saline (sodium chloride 0.3%) + albuterol |
| FG001 | Normal | Normal saline (sodium chloride 0.9%) + albuterol |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypertonic | Hypertonic saline (sodium chloride 0.3%) + albuterol |
| BG001 | Normal | Normal saline (sodium chloride 0.9%) + albuterol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Length of Oxygen Use | Length of oxygen use (days) | Posted | Median | Standard Deviation | days | Participants will be followed for the duration of hospitalization, an expected average of 4 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hypertonic | Hypertonic saline (sodium chloride 0.3%) + albuterol |
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The initially estimated sample size was not achieved
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria I. Espelt, MD | Hospital General de Niños Pedro de Elizalde | 541146136968 | cespelt@fibertel.com.ar |
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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 |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D000077324 | Crystalloid Solutions |
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| Normal saline | Drug | 3 cc nebulized normal saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days |
|
|
| 37014057 | Derived | Zhang L, Mendoza-Sassi RA, Wainwright CE, Aregbesola A, Klassen TP. Nebulised hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2023 Apr 4;4(4):CD006458. doi: 10.1002/14651858.CD006458.pub5. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | months |
|
| Gender | Count of Participants | Participants |
|
|
|
| Primary | Hospitalization Days | hospitalization days | Posted | Median | Standard Deviation | days | Participants will be followed for the duration of hospitalization, an expected average of 4 days |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Normal | Normal saline (sodium chloride 0.9%) + albuterol | 0 | 50 | 0 | 50 |
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| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D007552 |
| Isotonic Solutions |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |