Trial · NCT02834819
Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis
NCT02834819, Not applicable, Terminated, University of Colorado, Denver; results first posted 2020-02-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis. Trials, record NCT02834819. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02834819
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis
- NCT number
- NCT02834819
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 18 participants, actual
- Lead sponsor
- University of Colorado, Denver
- Conditions
- Bronchiolitis
- Interventions
- 3% Nebulized Hypertonic Saline
- First posted
- 2016-07-15
- Last updated
- 2020-02-11
- Results first posted
- 2020-02-11
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hospitalization Rate | 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 |
| Primary | Number of Patients With Persistent Hypoxia | 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. |
| Primary | Need for Supplemental Oxygen After Discharge | 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. |
| Secondary | Pre- Intervention Clinical Severity Score | During Enrollment visit following randomization. | Clinical severity score taken immediately following randomization, and prior to any intervention to assess change in baseline after intervention and compare change in scores, if any, between the two groups. The Scale utilized was the Clinical Severity Score from Wang et al, which measures respiratory distress in young children. The system assigns scores ranging from 0 to 3 for the following categories: respiratory rate, wheezing, retraction, and general condition. These category scores are then summed to come up with the final Clinical Severity Score. Total scores range from 0 to 12, with higher scores indicating greater severity/worse outcomes. |
| Secondary | Post-intervention Clinical Severity Score | During enrollment visit - 90 minutes after randomization | Clinical severity score taken at time 90 minutes in both arms to assess any change in clinical severity score from baseline. The Scale utilized was the Clinical Severity Score from Wang et al, which measures respiratory distress in young children. The system assigns scores ranging from 0 to3 for the following categories: respiratory rate, wheezing, retraction, and general condition. These category scores are then summed to come up with the final Clinical Severity Score. Total scores range from 0 to 12, with higher scores indicating greater severity/worse outcomes. |
| Secondary | Unscheduled Return ED Visits | Called at 7 days post enrollment visit to assess any visit within 3 days of enrollment visit | Unscheduled visit to ED within 3 days of enrollment visit. Patients in each group will be contacted 7 days after the enrollment visit to see if they had any unscheduled return ED visit within 3 days of the enrollment visit. |
| Secondary | Adverse Outcomes | During enrollment visit or within 7 days following enrollment visit | Respiratory distress, increased oxygen requirement, advanced airway interventions (NIPPV or intubation). |
| Secondary | Hospital Admission After Discharge | Within 7 days following discharge from enrollment visit | Admission to any hospital institution within 7 days following enrollment visit |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Hospitalization Rate | At any point during enrollment visit or up to 7 days after enrollment visit. | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Patients With Persistent Hypoxia | At baseline and 90 minutes post-intervention | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Need for Supplemental Oxygen After Discharge | At time of discharge from the hospital through 7 days. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Pre- Intervention Clinical Severity Score | During Enrollment visit following randomization. | score on a scale | MEAN | |
| SECONDARY | Post-intervention Clinical Severity Score | During enrollment visit - 90 minutes after randomization | score on a scale | MEAN | |
| SECONDARY | Unscheduled Return ED Visits | Called at 7 days post enrollment visit to assess any visit within 3 days of enrollment visit | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Adverse Outcomes | During enrollment visit or within 7 days following enrollment visit | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Hospital Admission After Discharge | Within 7 days following discharge from enrollment visit | 5 patients did not complete the 7 day phone call and were not able to be analyzed for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Hospitalization Rate | Hypertonic Saline | 2 | Participants | ||
| Hospitalization Rate | No Treatment | 1 | Participants | ||
| Number of Patients With Persistent Hypoxia | Hypertonic Saline | 9 | Participants | ||
| Number of Patients With Persistent Hypoxia | No Treatment | 9 | Participants | ||
| Need for Supplemental Oxygen After Discharge | Hypertonic Saline | 9 | Participants | ||
| Need for Supplemental Oxygen After Discharge | No Treatment | 9 | Participants | ||
| Pre- Intervention Clinical Severity Score | Hypertonic Saline | 3.8 | Standard Deviation 1.8 | score on a scale | |
| Pre- Intervention Clinical Severity Score | No Treatment | 2.7 | Standard Deviation 2.04 | score on a scale | |
| Post-intervention Clinical Severity Score | Hypertonic Saline | 2.22 | Standard Deviation 1.48 | score on a scale | |
| Post-intervention Clinical Severity Score | No Treatment | 2.22 | Standard Deviation 2.22 | score on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hypertonic Saline | 9 | |
| Overall Study | STARTED | No Treatment | 9 | |
| Overall Study | COMPLETED | Hypertonic Saline | 4 | |
| Overall Study | COMPLETED | No Treatment | 9 | |
| Overall Study | NOT COMPLETED | Hypertonic Saline | 5 | |
| Overall Study | NOT COMPLETED | No Treatment | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hypertonic Saline | 0 | 9 |
| Total, all-cause mortality | No Treatment | 0 | 9 |
| Total, other adverse events | Hypertonic Saline | 0 | 9 |
| Total, other adverse events | No Treatment | 0 | 9 |
| Total, serious adverse events | Hypertonic Saline | 0 | 9 |
| Total, serious adverse events | No Treatment | 0 | 9 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Hypertonic Saline vs No Treatment: Unscheduled Return ED Visits | Trial comparisons |
| Hypertonic Saline vs No Treatment: Adverse Outcomes | Trial comparisons |
| Hypertonic Saline vs No Treatment: Hospitalization Rate | Trial comparisons |
| Hypertonic Saline vs No Treatment: Need for Supplemental Oxygen After Discharge | Trial comparisons |
| Hypertonic Saline vs No Treatment: Number of Patients With Persistent Hypoxia | Trial comparisons |
| Hypertonic Saline vs No Treatment: deaths from any cause | Trial comparisons |
| Hypertonic Saline vs No Treatment: Hospital Admission After Discharge | Trial comparisons |
| Hypertonic Saline vs No Treatment: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02834819
GET https://conductscience.org/api/trials/v1/NCT02834819/registered