Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis
|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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834819
|Principal Investigator:||Cortney Braund, MD||University of Colorado, Denver|