Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis
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|ClinicalTrials.gov Identifier: NCT02834819|
Recruitment Status : Terminated (Lack of financial support)
First Posted : July 15, 2016
Last Update Posted : July 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis||Drug: 3% Nebulized Hypertonic Saline||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Controlled Trial of Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Experimental: Hypertonic Saline
Patients randomized to the hypertonic saline group will be administered one nebulized treatment of 3% hypertonic saline. They will also receive what is considered standard of care, which includes suctioning and supportive care as needed.
Drug: 3% Nebulized Hypertonic Saline
No Intervention: No treatment
Patients in the "No treatment" arm will receive no additional treatment other than standard of care, which includes suctioning and supportive care as needed.
- Hospitalization Rate [ Time Frame: At any point during enrollment visit or up to 7 days after enrollment visit. ]Effect of nebulized 3% hypertonic saline on hospitalization rate in children with bronchiolitis compared to those who receive the current standard of care
- Persistent Hypoxia [ Time Frame: At baseline and 90 minutes post-intervention ]To assess the effect of nebulized hypertonic saline on hypoxia in children with bronchiolitis compared to those who receive current standard of care.
- Need for Supplemental Oxygen after discharge [ Time Frame: At time of discharge from the hospital through 7 days. ]To assess the effect of nebulized hypertonic saline on supplemental home oxygen requirement in children with bronchiolitis compared to those who receive the current standard of care.
- Pre- Intervention clinical severity score [ Time Frame: During Enrollment visit following randomization. ]Clinical severity score taken immediately following randomization, and prior to any intervention.
- Post-intervention clinical severity score [ Time Frame: During enrollment visit - 90 minutes after randomization ]Clinical severity score taken at time 90 minutes in both arms.
- Unscheduled return ED visits [ Time Frame: 7 days post enrollment visit ]Unscheduled visit to ED within 3 days of enrollment visit
- Adverse outcomes [ Time Frame: During enrollment visit or within 7 days following enrollment visit ]Respiratory distress, increased oxygen requirement, advanced airway interventions (NIPPV or intubation).
- Hospital Admission after Discharge [ Time Frame: Within 7 days following discharge from enrollment visit ]Admission to any hospital institution within 7 days following enrollment visit
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834819
|Principal Investigator:||Cortney Braund, MD||University of Colorado, Denver|