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The purpose of this study is to determine if nebulized hypertonic saline (or extra salty water mist) helps infants less than 12 months old hospitalized with bronchiolitis (or bad chest colds) get better enough to be discharged from the hospital sooner than those infants given nebulized normal saline (or regular salty water mist).
Bronchiolitis is a common admitting diagnosis for children less than 1 year of age. Although bronchiolitis has a high prevalence, there is a lack of a unified inpatient treatment plan beyond supportive care of supplemental oxygen and intravenous hydration. There have been many different approaches to the treatment of bronchiolitis, but none have conclusively proven to be beneficial. Several early studies show promise for the use of nebulized hypertonic saline, however the majority of these studies are done outside the United States and with adjunctive therapy. To date, the data suggesting that nebulized hypertonic saline is safe and effective for reducing length of stay in bronchiolitis is strong but not generalizable for the United States. The objective of this study is to conduct the first double-blind, randomized controlled trial in the United States of nebulized hypertonic saline without adjunctive therapy, including infants with bronchiolitis, including those with prior history of wheeze, to assess the effect on length of stay and therefore resource utilization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebulized Hypertonic Saline | Experimental | 4mL nebulized 3% sodium chloride every 4 hours until discharge |
|
| Nebulized Normal Saline | Placebo Comparator | 4 mL nebulized 0.9% sodium chloride every 4 hours until discharge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3% sodium chloride | Drug | 4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay in the Study-LOS--Intention to Treat Analysis | Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used. | Time of first study treatment until time of discharge |
| Length of Stay in the Study-LOS by Per Protocol Analysis | Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used. | Time of first study treatment until time of discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Readmission for Bronchiolitis Within 7 Days of Discharge | Phone call at 7 days to assess for readmission to any hospital | within 7 days of hospital discharge |
| Clinical Worsening | transfer to the Pediatric Intensive Care Unit (PICU) (including withdrawn from the study for bronchodilator administration who were then transferred to the PICU), or Respiratory Distress Assessment Instrument (RDAI) increase of 4 or more points within 30 minutes of a study treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alyssa H Silver, MD | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital at Montefiore | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26553190 | Derived | Silver AH, Esteban-Cruciani N, Azzarone G, Douglas LC, Lee DS, Liewehr S, Nazif JM, Agalliu I, Villegas S, Rhim HJ, Rinke ML, O'Connor K. 3% Hypertonic Saline Versus Normal Saline in Inpatient Bronchiolitis: A Randomized Controlled Trial. Pediatrics. 2015 Dec;136(6):1036-43. doi: 10.1542/peds.2015-1037. Epub 2015 Nov 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypertonic Saline | 4 mL nebulized 3% sodium chloride every 4 hours until discharge |
| FG001 | Normal Saline | 4 mL nebulized 0.9% sodium chloride every 4 hours until discharge |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypertonic Saline | 4 mL nebulized 3% sodium chloride every 4 hours until discharge |
| BG001 | Normal Saline | 4 mL nebulized 0.9% sodium chloride every 4 hours until discharge |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Length of Stay in the Study-LOS--Intention to Treat Analysis | Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used. | Intention to Treat Analysis | Posted | Median | Inter-Quartile Range | Days | Time of first study treatment until time of discharge |
|
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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 | 4 mL nebulized 3% sodium chloride every 4 hours until discharge |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transfer to PICU | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alyssa Silver | Children's Hospital at Montefiore/Albert Einstein College of Medicine | 718-741-2304 | alysilve@montefiore.org |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D012135 | Respiratory Sounds |
| 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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| 0.9% sodium chloride | Drug | 4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge |
|
|
| though hospitalization/time period receiving study treatment, average 2-3 days |
| Total Adverse Events | Clinical worsening events (defined prior) + 7 day readmissions | Time of enrollment in the study through 1 week after hospital discharge |
| Physician Decision |
|
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
|
|
|
| Secondary | Readmission for Bronchiolitis Within 7 Days of Discharge | Phone call at 7 days to assess for readmission to any hospital | This population is those who completed the study. | Posted | Number | participants | within 7 days of hospital discharge |
|
|
|
|
| Secondary | Clinical Worsening | transfer to the Pediatric Intensive Care Unit (PICU) (including withdrawn from the study for bronchodilator administration who were then transferred to the PICU), or Respiratory Distress Assessment Instrument (RDAI) increase of 4 or more points within 30 minutes of a study treatment | all patients enrolled in the study were analyzed for events related to clinical worsening | Posted | Number | participants | though hospitalization/time period receiving study treatment, average 2-3 days |
|
|
|
|
| Secondary | Total Adverse Events | Clinical worsening events (defined prior) + 7 day readmissions | Posted | Number | adverse events | Time of enrollment in the study through 1 week after hospital discharge |
|
|
|
|
| Post-Hoc | LOS in Subgroup of Patients With Testing Positive for Respiratory Syncitial Virus (RSV+) | This is the population in the study whose RSV testing was positive. | Posted | Median | Inter-Quartile Range | days | through hospitalization/while receiving study medication, average 2-3 days |
|
|
|
|
| Post-Hoc | LOS in Patients With a History of Previous Wheeze | Subgroup of the study population who reported a history of wheezing prior to this admission | Posted | Median | Inter-Quartile Range | days | through hospitalization/while receiving study medication, average 2-3 days |
|
|
|
|
| Post-Hoc | LOS Subgroup Analysis of Patients With a History of Prematurity | Patients who reported a history of prematurity/whose Gestational age was <37 weeks | Posted | Median | Inter-Quartile Range | days | through hospitalization/while receiving study medication, average 2-3 days |
|
|
|
| Post-Hoc | LOS Analysis for Patients Whose Study Entry Respiratory Distress Assessment Instrument (RDAI) Was Greater Than or Equal to 4 or Who Had Hypoxia <92% | Subgroup of patients who had a study entry Respiratory Distress Assessment Instrument (RDAI) of greater than or equal to 4 points OR hypoxia <92% on admission | Posted | Median | Inter-Quartile Range | days | through hospitalization/while receiving study medication, average 2-3 days |
|
|
|
| Primary | Length of Stay in the Study-LOS by Per Protocol Analysis | Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used. | Per protocol analysis (only includes participants who completed the study) | Posted | Median | Inter-Quartile Range | Days | Time of first study treatment until time of discharge |
|
|
|
|
| 13 |
| 113 |
| 0 |
| 113 |
| EG001 | Normal Saline | 4mL nebulized 0.9% sodium chloride every 4 hours until discharge | 10 | 114 | 0 | 114 |
| Readmission-respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Readmission-non-respiratory | Investigations | Systematic Assessment |
|
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| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |