A Phase 4 interventional study of Nebulized 3% sodium chloride solution and Chest percussion cups in Acute Bronchiolitis, sponsored by NYU Langone Health. Terminated at 1 site in United States. Open to participants aged 0 Months to 24 Months. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by NYU Langone Health · Phase 4, Interventional, and Treatment
This study will examine the efficacy of combined nebulized hypertonic saline with chest percussion therapy in patients age 0 to 24 months admitted to the general inpatient pediatrics unit with acute bronchiolitis. 3% nebulized hypertonic saline treatments combined with 3 minutes of chest percussion therapy will be administered every 6 hours of patients selected for the study.
NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
In order to be eligible to participate in this study (experimental arm), an individual must meet all of the following criteria:
Data collected for the control arm will be obtained via retrospective chart review for patients meeting the following inclusion criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
A potential study subject in the control arm via retrospective chart review who meets any of the following criteria will be excluded from this study:
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.
Drug: Nebulized 3% sodium chloride solution · Device: Chest percussion cups
Participants in the control arm will be analyzed via retrospective chart review; these participants will not be consented nor enrolled in the trial.
Standardized dose of nebulized 3% sodium chloride will be provided from 4 mL vial and administered be every 6 hours.
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.
Also known as: MC-2247 Pediatric Manual Percussor Cup
Length of Hospital Stay
Measured in days from from time of admission to the general inpatient pediatrics unit until time of discharge from the general inpatient pediatrics unit.
Time frame: Up to time of discharge (Approximately 1-5 days on average)
Time on Supplemental Oxygen Support
Measured in days from from time of admission to the general inpatient pediatrics unit until time of discharge from the general inpatient pediatrics unit.
Time frame: Up to time of discharge (Approximately 1-5 days on average)
Average Respiratory Rate
Assessed every 4 hours and as needed in addition.
Time frame: Up to time of discharge (Approximately 1-5 days on average)
Average Heart Rate
Assessed every 4 hours and as needed in addition.
Time frame: Up to time of discharge (Approximately 1-5 days on average)
Average Pulse Oximetry Reading
Assessed every 4 hours and as needed in addition.
Time frame: Up to time of discharge (Approximately 1-5 days on average)
Number of Caregivers Who Rate Child's Response as "Improved"
Caregivers will be given a survey in which they will rate their child's overall response following the treatments as "Improved," "Unchanged," or "Worsened."
Time frame: Time of discharge (Approximately 1-5 days on average)
Number of Physicians Who Rate Child's Response as "Improved"
Caregivers will be given a survey in which they will rate their child's overall response following the treatments as "Improved," "Unchanged," or "Worsened."
Time frame: Time of discharge (Approximately 1-5 days on average)
| Milestone | Nebulized Hypertonic Saline + Chest Percussion Therapy | Control Arm |
|---|---|---|
| Started | 5 | 70 |
| Completed | 0 | 0 |
| Not completed | 5 | 70 |
| Withdrew: Protocol violation | 3 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Retrospective chart review not completed | 0 | 70 |
Measured in days from from time of admission to the general inpatient pediatrics unit until time of discharge from the general inpatient pediatrics unit.
No measurements were reported for this outcome.
Measured in days from from time of admission to the general inpatient pediatrics unit until time of discharge from the general inpatient pediatrics unit.
No measurements were reported for this outcome.
Assessed every 4 hours and as needed in addition.
No measurements were reported for this outcome.
Assessed every 4 hours and as needed in addition.
No measurements were reported for this outcome.
Assessed every 4 hours and as needed in addition.
No measurements were reported for this outcome.
Caregivers will be given a survey in which they will rate their child's overall response following the treatments as "Improved," "Unchanged," or "Worsened."
No measurements were reported for this outcome.
Caregivers will be given a survey in which they will rate their child's overall response following the treatments as "Improved," "Unchanged," or "Worsened."
No measurements were reported for this outcome.
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nebulized Hypertonic Saline + Chest Percussion Therapy | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Control Arm | 0/70 (0%) | 0/70 (0%) | 0/70 (0%) |
Five patients were enrolled, but the study proved infeasible on the inpatient pediatrics unit due to uncontrolled variables and non-adherence (e.g., differing attending practices, forgotten order unlinks). Seventy retrospective controls were identified, but chart review and analysis were not done. No prospective subjects completed the protocol, no data were collected, and the study is closed with no data to analyze or publish.
| Age, Continuous(months) | Nebulized Hypertonic Saline + Chest Percussion Therapy | Control Arm | Total |
|---|---|---|---|
| Mean | 6 (2 to 17) | 9 (1 to 24) | 8 (1 to 24) |
| Sex: Female, Male(Participants) | Nebulized Hypertonic Saline + Chest Percussion Therapy | Control Arm | Total |
|---|---|---|---|
| Female | 0 | 31 | 31 |
| Male | 5 | 39 | 44 |
| Ethnicity (NIH/OMB)(Participants) | Nebulized Hypertonic Saline + Chest Percussion Therapy | Control Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 38 | 38 |
| Not Hispanic or Latino | 5 | 30 | 35 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Race (NIH/OMB)(Participants) | Nebulized Hypertonic Saline + Chest Percussion Therapy | Control Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 2 | 28 | 30 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 38 | 39 |
| Region of Enrollment(participants) | Nebulized Hypertonic Saline + Chest Percussion Therapy | Control Arm | Total |
|---|---|---|---|
| United States | 5 | 70 | 75 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Tuan Nguyen tuan.nguyen@nyulangone.org 405-535-7093 The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Sap, Icf, Csr
This study is terminated, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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