Trial Outcomes & Findings for Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis (NCT NCT02834819)

Results Overview

Effect of nebulized 3% hypertonic saline on hospitalization rate in children with bronchiolitis compared to those who receive the current standard of care

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

At any point during enrollment visit or up to 7 days after enrollment visit.

Results posted on

2020-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	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. 3% Nebulized Hypertonic Saline	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.
Overall Study STARTED	9	9
Overall Study COMPLETED	4	9
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 3% Nebulized Hypertonic Saline	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.
Overall Study Did not complete 7 day follow up call.	5	0

Baseline Characteristics

Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hypertonic Saline n=9 Participants 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. 3% Nebulized Hypertonic Saline	No Treatment n=9 Participants Patients in the "No treatment" arm will receive no additional treatment other than standard of care, which includes suctioning and supportive care as needed.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	202.22 days STANDARD_DEVIATION 109.37 • n=5 Participants	255.33 days STANDARD_DEVIATION 122.43 • n=7 Participants	228.77 days STANDARD_DEVIATION 115.88 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Hypertonic Saline n=9 Participants 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. 3% Nebulized Hypertonic Saline	No Treatment n=9 Participants 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	2 Participants	1 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Hypertonic Saline n=9 Participants 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. 3% Nebulized Hypertonic Saline	No Treatment n=9 Participants Patients in the "No treatment" arm will receive no additional treatment other than standard of care, which includes suctioning and supportive care as needed.
Number of Patients With Persistent Hypoxia	9 Participants	9 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Hypertonic Saline n=9 Participants 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. 3% Nebulized Hypertonic Saline	No Treatment n=9 Participants Patients in the "No treatment" arm will receive no additional treatment other than standard of care, which includes suctioning and supportive care as needed.
Need for Supplemental Oxygen After Discharge	9 Participants	9 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Hypertonic Saline n=9 Participants 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. 3% Nebulized Hypertonic Saline	No Treatment n=9 Participants Patients in the "No treatment" arm will receive no additional treatment other than standard of care, which includes suctioning and supportive care as needed.
Pre- Intervention Clinical Severity Score	3.8 score on a scale Standard Deviation 1.8	2.7 score on a scale Standard Deviation 2.04

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Hypertonic Saline n=9 Participants 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. 3% Nebulized Hypertonic Saline	No Treatment n=9 Participants Patients in the "No treatment" arm will receive no additional treatment other than standard of care, which includes suctioning and supportive care as needed.
Post-intervention Clinical Severity Score	2.22 score on a scale Standard Deviation 1.48	2.22 score on a scale Standard Deviation 2.22

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Hypertonic Saline n=9 Participants 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. 3% Nebulized Hypertonic Saline	No Treatment n=9 Participants Patients in the "No treatment" arm will receive no additional treatment other than standard of care, which includes suctioning and supportive care as needed.
Unscheduled Return ED Visits	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During enrollment visit or within 7 days following enrollment visit

Respiratory distress, increased oxygen requirement, advanced airway interventions (NIPPV or intubation).

Outcome measures

Outcome measures
Measure	Hypertonic Saline n=9 Participants 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. 3% Nebulized Hypertonic Saline	No Treatment n=9 Participants Patients in the "No treatment" arm will receive no additional treatment other than standard of care, which includes suctioning and supportive care as needed.
Adverse Outcomes	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 7 days following discharge from enrollment visit

Population: 5 patients did not complete the 7 day phone call and were not able to be analyzed for this outcome measure.

Admission to any hospital institution within 7 days following enrollment visit

Outcome measures

Outcome measures
Measure	Hypertonic Saline n=4 Participants 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. 3% Nebulized Hypertonic Saline	No Treatment n=9 Participants Patients in the "No treatment" arm will receive no additional treatment other than standard of care, which includes suctioning and supportive care as needed.
Hospital Admission After Discharge	0 Participants	0 Participants

Adverse Events

Hypertonic Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cortney Braund, MD

Children's Hospital Colorado/University of Colorado

Phone: 4406696880

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place