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| Name | Class |
|---|---|
| UCSF Benioff Children's Hospital Oakland | OTHER |
| Thrasher Research Fund | OTHER |
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This study aims to examine the effect of nebulized 3% hypertonic saline in the treatment of viral bronchiolitis. The investigators hypothesize that nebulized 3% saline will decrease rate of hospital admission, decrease clinical severity scores, and decrease length of stay.
Bronchiolitis is the most common viral respiratory infection in young children and infants. It is responsible for hundreds of thousands of outpatient visits and hospitalizations every year. Hypertonic saline may decrease swelling in the lung tissue, improve the patient's ability to clear secretions, and decrease nasal congestion. Hypertonic saline nebulizations have already been used effectively in patients with cystic fibrosis and in a few small trials on infants with bronchiolitis. Patients who come to the emergency department or inpatient ward of two urban free-standing pediatric hospitals in California between December and April and are diagnosed with bronchiolitis will be randomized into two groups- the control group will receive nebulized 0.9% normal saline, while the study group will receive nebulized 3% hypertonic saline. Nebulizations will be pretreated with albuterol, to prevent the theoretical risk of increased wheezing in patients with undiagnosed underlying asthma. Patients will be given up to 3 nebulizations in the emergency department, after which time the attending physician will decide whether admission to the hospital is required. Patients who are admitted will continue to receive the same nebulized treatment every 8 hours until discharged. Additional interventions such as epinephrine treatments and antibiotics can be ordered as indicated by the patient care team.
Investigators will measure symptom severity before and after treatments using the respiratory distress assessment instrument (RDAI). The investigators will compare rates of being admitted to the hospital in each group. The investigators will also compare RDAI scores, average length of stay, number of additional respiratory treatments needed, number of hours requiring oxygen, amount of IV fluid needed, and frequency of adverse effects. The investigators hypothesize that nebulized hypertonic saline will be a safe, cost-effective, and efficacious therapy which can be utilized in the outpatient setting to prevent hospital admission, as well as decrease length of stay for patients who require admission. Given the significant disease burden of viral bronchiolitis, the potential impact is substantial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebulized 3% Saline | Experimental | 3% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting. |
|
| Nebulized 0.9% Saline | Placebo Comparator | 0.9% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebulized 3% saline | Drug | 4 ml inhaled q8h |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Admission Rate | Patients enrolled in the ED who required inpatient admission. Patients who required admission but were transferred to another facility due to lack of available beds were considered admitted for this outcome. Note, neither study site has an observation unit. | 1 day |
| Length of Stay | Length of stay defined as date of discharge minus date of admission (whole days) | 1 month |
| Change in RDAI Score | The Respiratory Distress Assessment Instrument (RDAI) is a respiratory severity score ranging from a low score of 0 to maximum score of 17. Lower scores indicate more mild symptoms; mild disease (0-6), moderate disease (7-11), and severe (12-17). A decrease in score of 2 is considered clinically significant improvement. | 1 Hour |
| Measure | Description | Time Frame |
|---|---|---|
| Hours of Oxygen Use | Hours requiring supplemental oxygen for admitted patients. | 14 days |
| IV Fluid Use | IV fluid volume administered during entire hospitalization, in mL/kg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Wu, MD | Childrens Hospital Los Angeles/University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| Children's Hospital & Research Center at Oakland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24862623 | Derived | Wu S, Baker C, Lang ME, Schrager SM, Liley FF, Papa C, Mira V, Balkian A, Mason WH. Nebulized hypertonic saline for bronchiolitis: a randomized clinical trial. JAMA Pediatr. 2014 Jul;168(7):657-63. doi: 10.1001/jamapediatrics.2014.301. |
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No patients were excluded after enrollment but before randomization.
Subjects were recruited beginning March 2008 and April 2011, only during months of bronchiolitis season (November through April). Recruitment occurred in the emergency department and general medical inpatient units at 2 urban tertiary free-standing children's hospitals in the U.S.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypertonic Saline | 3% NaCl, 4 ml, via updraft wall nebulizer:
|
| FG001 | Normal Saline | 0.9% NaCl, 4 ml, via updraft wall nebulizer:
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| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypertonic Saline | 3% NaCl, 4 ml, via updraft wall nebulizer:
|
| BG001 | Normal Saline | 0.9% NaCl, 4 ml, via updraft wall nebulizer:
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| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Admission Rate | Patients enrolled in the ED who required inpatient admission. Patients who required admission but were transferred to another facility due to lack of available beds were considered admitted for this outcome. Note, neither study site has an observation unit. | Analysis for this outcome only includes patients who were enrolled in the ED, and not patients enrolled in the inpatient setting. | Posted | Number | participants | 1 day |
|
Patient enrollment through duration of hospitalization (average 3.5 days)
The number of participants at risk is different from the number started because one patient randomized to the normal saline group received hypertonic saline.
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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 Saline | 3% NaCl, 4 ml, via updraft wall nebulizer:
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ICU admission | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Patients requiring admission or transfer to the PICU or NICU |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Wu | Children's Hospital Los Angeles | 323-361-6177 | suwu@chla.usc.edu |
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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 |
|---|---|
| D012965 | Sodium Chloride |
| D012462 | Saline Solution, Hypertonic |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Nebulized 0.9% saline | Drug | normal saline |
|
|
| 14 days |
| Number of Participants With Supplemental Medication Use | patients who received supplemental albuterol, ipratropium, or epinephrine inhaled treatment (other than pre-treatment for study med) | 14 days |
| Oakland |
| California |
| 94609 |
| United States |
| Transfer to outside facility |
|
| Left before receiving first dose |
|
| ICU admission |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Primary | Length of Stay | Length of stay defined as date of discharge minus date of admission (whole days) | Analysis for this outcome only includes patients who were admitted to inpatient status at the enrolling hospital and not transferred out. | Posted | Mean | Standard Deviation | Days | 1 month |
|
|
|
| Primary | Change in RDAI Score | The Respiratory Distress Assessment Instrument (RDAI) is a respiratory severity score ranging from a low score of 0 to maximum score of 17. Lower scores indicate more mild symptoms; mild disease (0-6), moderate disease (7-11), and severe (12-17). A decrease in score of 2 is considered clinically significant improvement. | Excludes patients who did not receive any doses of study medication (17), patients missing pre-tx score (7), post-tx score (4), or both (1). | Posted | Mean | Standard Deviation | units on a scale | 1 Hour |
|
|
|
| Secondary | Hours of Oxygen Use | Hours requiring supplemental oxygen for admitted patients. | Excludes patients withdrawn by investigator due to ICU admission or ineligible condition (12), withdrawn by parent (6), and missing data (3) | Posted | Mean | Standard Deviation | hours | 14 days |
|
|
|
| Secondary | IV Fluid Use | IV fluid volume administered during entire hospitalization, in mL/kg | Excludes patients withdrawn by investigator due to ICU admission or ineligible condition (12), withdrawn by parent (6), and missing data (3) | Posted | Mean | Standard Deviation | mL/kg | 14 days |
|
|
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| Secondary | Number of Participants With Supplemental Medication Use | patients who received supplemental albuterol, ipratropium, or epinephrine inhaled treatment (other than pre-treatment for study med) | 230 patients were allocated to the 3% group; one patient allocated to the 0.9% group received 3% so was added to the 3% group for analysis, totaling 231 patients. The 0.9% group originally had 217 patients but after moving this patient to the 3% group, there are now 216 patients in the 0.9% group. | Posted | Count of Participants | Participants | 14 days |
|
|
|
| 0 |
| 231 |
| 0 |
| 231 |
| 5 |
| 231 |
| EG001 | Normal Saline | 0.9% NaCl, 4 ml, via updraft wall nebulizer:
| 0 | 216 | 0 | 216 | 8 | 216 |
|
| Worsening cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Parent or provider perception of worsening cough |
|
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| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D017670 |
| Sodium Compounds |
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |