Trial Outcomes & Findings for Efficacy Of Combined Nebulized Hypertonic Saline and Chest Percussion Therapy in Acute Viral Bronchiolitis (NCT NCT06441162)
NCT ID: NCT06441162
Last Updated: 2026-02-20
Results Overview
Measured in days from from time of admission to the general inpatient pediatrics unit until time of discharge from the general inpatient pediatrics unit.
TERMINATED
PHASE4
75 participants
Up to time of discharge (Approximately 1-5 days on average)
2026-02-20
Participant Flow
Participant milestones
| Measure |
Nebulized Hypertonic Saline + Chest Percussion Therapy
Participants with acute viral bronchiolitis will receive 3% nebulized hypertonic saline treatments combined with 3 minutes of chest percussion therapy. This will be administered every 6 hours.
Nebulized 3% sodium chloride solution: Standardized dose of nebulized 3% sodium chloride will be provided from 4 mL vial and administered be every 6 hours.
Chest percussion cups: The chest percussion cup is a small, flexible cup made of vinyl that is used to provide gentle chest wall vibrations to assist with airway clearance and is utilized in patients of all ages with sputum production, such as those with acute bronchiolitis. Administered every 6 hours while on supplemental oxygen therapy.
|
Control Arm
Participants in the control arm will be analyzed via retrospective chart review; these participants will not be consented nor enrolled in the trial.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
70
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
70
|
Reasons for withdrawal
| Measure |
Nebulized Hypertonic Saline + Chest Percussion Therapy
Participants with acute viral bronchiolitis will receive 3% nebulized hypertonic saline treatments combined with 3 minutes of chest percussion therapy. This will be administered every 6 hours.
Nebulized 3% sodium chloride solution: Standardized dose of nebulized 3% sodium chloride will be provided from 4 mL vial and administered be every 6 hours.
Chest percussion cups: The chest percussion cup is a small, flexible cup made of vinyl that is used to provide gentle chest wall vibrations to assist with airway clearance and is utilized in patients of all ages with sputum production, such as those with acute bronchiolitis. Administered every 6 hours while on supplemental oxygen therapy.
|
Control Arm
Participants in the control arm will be analyzed via retrospective chart review; these participants will not be consented nor enrolled in the trial.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Retrospective chart review not completed
|
0
|
70
|
Baseline Characteristics
Efficacy Of Combined Nebulized Hypertonic Saline and Chest Percussion Therapy in Acute Viral Bronchiolitis
Baseline characteristics by cohort
| Measure |
Nebulized Hypertonic Saline + Chest Percussion Therapy
n=5 Participants
Participants with acute viral bronchiolitis will receive 3% nebulized hypertonic saline treatments combined with 3 minutes of chest percussion therapy. This will be administered every 6 hours.
Nebulized 3% sodium chloride solution: Standardized dose of nebulized 3% sodium chloride will be provided from 4 mL vial and administered be every 6 hours.
Chest percussion cups: The chest percussion cup is a small, flexible cup made of vinyl that is used to provide gentle chest wall vibrations to assist with airway clearance and is utilized in patients of all ages with sputum production, such as those with acute bronchiolitis. Administered every 6 hours while on supplemental oxygen therapy.
|
Control Arm
n=70 Participants
Participants in the control arm will be analyzed via retrospective chart review; these participants will not be consented nor enrolled in the trial.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6 months
n=14 Participants
|
9 months
n=14 Participants
|
8 months
n=29 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=14 Participants
|
31 Participants
n=14 Participants
|
31 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=14 Participants
|
39 Participants
n=14 Participants
|
44 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
38 Participants
n=14 Participants
|
38 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=14 Participants
|
30 Participants
n=14 Participants
|
35 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
2 Participants
n=14 Participants
|
2 Participants
n=29 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
2 Participants
n=14 Participants
|
2 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=14 Participants
|
2 Participants
n=14 Participants
|
4 Participants
n=29 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=14 Participants
|
28 Participants
n=14 Participants
|
30 Participants
n=29 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=14 Participants
|
38 Participants
n=14 Participants
|
39 Participants
n=29 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=14 Participants
|
70 participants
n=14 Participants
|
75 participants
n=29 Participants
|
PRIMARY outcome
Timeframe: Up to time of discharge (Approximately 1-5 days on average)Population: Five prospective patients were enrolled, but the design proved infeasible on the general inpatient pediatrics unit at the investigation site due to uncontrolled variables and protocol non-adherence, and no data was collected. Seventy retrospective controls were identified, but chart review/analysis were not done. No subjects completed the protocol; no data were collected. Data were not collected due to study termination prior to participants' assessment at the pre-specified time points.
Measured in days from from time of admission to the general inpatient pediatrics unit until time of discharge from the general inpatient pediatrics unit.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to time of discharge (Approximately 1-5 days on average)Population: Five prospective patients were enrolled, but the design proved infeasible on the general inpatient pediatrics unit at the investigation site due to uncontrolled variables and protocol non-adherence, and no data was collected. Seventy retrospective controls were identified, but chart review/analysis were not done. No subjects completed the protocol; no data were collected. Data were not collected due to study termination prior to participants' assessment at the pre-specified time points.
Measured in days from from time of admission to the general inpatient pediatrics unit until time of discharge from the general inpatient pediatrics unit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to time of discharge (Approximately 1-5 days on average)Population: Five prospective patients were enrolled, but the design proved infeasible on the general inpatient pediatrics unit at the investigation site due to uncontrolled variables and protocol non-adherence, and no data was collected. Seventy retrospective controls were identified, but chart review/analysis were not done. No subjects completed the protocol; no data were collected. Data were not collected due to study termination prior to participants' assessment at the pre-specified time points.
Assessed every 4 hours and as needed in addition.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to time of discharge (Approximately 1-5 days on average)Population: Five prospective patients were enrolled, but the design proved infeasible on the general inpatient pediatrics unit at the investigation site due to uncontrolled variables and protocol non-adherence, and no data was collected. Seventy retrospective controls were identified, but chart review/analysis were not done. No subjects completed the protocol; no data were collected. Data were not collected due to study termination prior to participants' assessment at the pre-specified time points.
Assessed every 4 hours and as needed in addition.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to time of discharge (Approximately 1-5 days on average)Population: Five prospective patients were enrolled, but the design proved infeasible on the general inpatient pediatrics unit at the investigation site due to uncontrolled variables and protocol non-adherence, and no data was collected. Seventy retrospective controls were identified, but chart review/analysis were not done. No subjects completed the protocol; no data were collected. Data were not collected due to study termination prior to participants' assessment at the pre-specified time points.
Assessed every 4 hours and as needed in addition.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time of discharge (Approximately 1-5 days on average)Population: Five prospective patients were enrolled, but the design proved infeasible on the general inpatient pediatrics unit at the investigation site due to uncontrolled variables and protocol non-adherence, and no data was collected. Seventy retrospective controls were identified, but chart review/analysis were not done. No subjects completed the protocol; no data were collected. Data were not collected due to study termination prior to participants' assessment at the pre-specified time points.
Caregivers will be given a survey in which they will rate their child's overall response following the treatments as "Improved," "Unchanged," or "Worsened."
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time of discharge (Approximately 1-5 days on average)Population: Five prospective patients were enrolled, but the design proved infeasible on the general inpatient pediatrics unit at the investigation site due to uncontrolled variables and protocol non-adherence, and no data was collected. Seventy retrospective controls were identified, but chart review/analysis were not done. No subjects completed the protocol; no data were collected. Data were not collected due to study termination prior to participants' assessment at the pre-specified time points.
Caregivers will be given a survey in which they will rate their child's overall response following the treatments as "Improved," "Unchanged," or "Worsened."
Outcome measures
Outcome data not reported
Adverse Events
Control Arm
Nebulized Hypertonic Saline + Chest Percussion Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place