Acute BronchiolitisPhase 4NCT06441162
Efficacy Of Combined Nebulized Hypertonic Saline and Chest Percussion Therapy in Acute Viral Bronchiolitis
A Phase 4 study testing Nebulized 3% sodium chloride solution and Chest percussion cups in people with Acute Bronchiolitis, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 24 months
- Conditions the study is for
- Acute Bronchiolitis
- What is being tested?
- Nebulized 3% sodium chloride solution and Chest percussion cups
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2024to 15 May 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- In order to be eligible to participate in this study (experimental arm), an individual must meet all of the following criteria:
- Age 0 to 24 months
- Admitted to the general inpatient pediatrics unit
- Has a diagnosis of acute bronchiolitis
- Receiving supplemental oxygen support
- Data collected for the control arm will be obtained via retrospective chart review for patients meeting the following inclusion criteria:
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- Age 0 to 24 months
- Admitted to the general inpatient pediatrics unit
- Has a diagnosis of acute bronchiolitis
- Receiving supplemental oxygen support
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Admitted to the pediatric intensive care unit
- Has an underlying pre-existing condition that may affect the respiratory system (includes bronchopulmonary dysplasia, reactive airways disease, asthma, restrictive lung diseases, other chronic lung diseases, etc.)
- Has other comorbid conditions upon admission that may affect the respiratory system (includes pneumonia or other bacterial or fungal lung infections, acute exacerbation of reactive airways disease, acute exacerbation of asthma, pulmonary edema, pleural effusion, etc.)
- Has an absolute contraindication to nebulized 3% hypertonic saline, for example, a history of an allergic or anaphylactic reaction
- Is receiving other respiratory treatments such as bronchodilator treatments (i.e. albuterol or levalbuterol)
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- Is receiving other adjuvant therapy such as antibiotics, antivirals, glucocorticoids, corticosteroids, or diuretics
- 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:
- Admitted to the pediatric intensive care unit
- Has an underlying pre-existing condition that may affect the respiratory system (includes bronchopulmonary dysplasia, reactive airways disease, asthma, restrictive lung diseases, other chronic lung diseases, etc.)
- Has other comorbid conditions upon admission that may affect the respiratory system (includes pneumonia or other bacterial or fungal lung infections, acute exacerbation of reactive airways disease, acute exacerbation of asthma, pulmonary edema, pleural effusion, etc.)
- Has an absolute contraindication to nebulized 3% hypertonic saline, for example, a history of an allergic or anaphylactic reaction
- Is receiving other respiratory treatments such as bronchodilator treatments (i.e. albuterol or levalbuterol)
- Is receiving other adjuvant therapy such as antibiotics, antivirals, glucocorticoids, corticosteroids, or diuretics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Non-randomized, Single-site Clinical Study Investigating the Efficacy of Combined Therapy of Nebulized 3% Hypertonic Saline and Chest Percussion Therapy in Pediatric Patients With Acute Viral Bronchiolitis.
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.
- Conditions
- Acute Bronchiolitis
- Being tested
- Nebulized 3% sodium chloride solution, Chest percussion cups
- Keywords
- acute bronchiolitis, nebulized hypertonic saline, chest percussion therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized 3% sodium chloride solutionDrug
Standardized dose of nebulized 3% sodium chloride will be provided from 4 mL vial and administered be every 6 hours.
Chest percussion cupsDevice
Also called MC-2247 Pediatric Manual Percussor Cup
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.
| Study group | Role | What they receive |
|---|---|---|
| Nebulized Hypertonic Saline + Chest Percussion Therapy | Experimental | 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. Receives: Drug: Nebulized 3% sodium chloride solution; Device: Chest percussion cups |
| Control Arm | No intervention | Participants in the control arm will be analyzed via retrospective chart review; these participants will not be consented nor enrolled in the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to time of discharge (Approximately 1-5 days on average)
Secondary outcomes (5)
Average Respiratory Rate
Assessed every 4 hours and as needed in addition.
Measured: Up to time of discharge (Approximately 1-5 days on average)
Average Heart Rate
Assessed every 4 hours and as needed in addition.
Measured: Up to time of discharge (Approximately 1-5 days on average)
Average Pulse Oximetry Reading
Assessed every 4 hours and as needed in addition.
Measured: 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."
Measured: 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."
Measured: Time of discharge (Approximately 1-5 days on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start15 Jul 2024
- Primary completion15 May 2025
- Study completion15 May 2025
Why it stopped: Study design proved infeasible on the general inpatient pediatrics unit at the investigation site due to uncontrolled variables and protocol non-adherence.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute BronchiolitisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tuan Nguyen, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441162
- Sponsor's protocol ID
- 23-01357
- Status last verified
- Feb 2026
- First submitted
- 29 May 2024
- Last updated
- 20 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Non-randomized, Single-site Clinical Study Investigating the Efficacy of Combined Therapy of Nebulized 3% Hypertonic Saline and Chest Percussion Therapy in Pediatric Patients With Acute Viral Bronchiolitis.
- ClinicalTrials.gov ID
- NCT06441162
- Acronym / sponsor ID
- 23-01357
- Conditions
- Acute Bronchiolitis
- Keywords
- acute bronchiolitis, nebulized hypertonic saline, chest percussion therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study design proved infeasible on the general inpatient pediatrics unit at the investigation site due to uncontrolled variables and protocol non-adherence.
- Enrolment
- 75 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Posted 20 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulized Hypertonic Saline + Chest Percussion Therapy | Experimental | Drug: Nebulized 3% sodium chloride solution, Device: Chest percussion cupsParticipants 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. |
| Control Arm | No intervention | –Participants in the control arm will be analyzed via retrospective chart review; these participants will not be consented nor enrolled in the trial. |
Who may qualify
- Ages
- 0 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- In order to be eligible to participate in this study (experimental arm), an individual must meet all of the following criteria:
- Age 0 to 24 months
- Admitted to the general inpatient pediatrics unit
- Has a diagnosis of acute bronchiolitis
- Receiving supplemental oxygen support
Key exclusion criteria (14 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Admitted to the pediatric intensive care unit
- Has an underlying pre-existing condition that may affect the respiratory system (includes bronchopulmonary dysplasia, reactive airways disease, asthma, restrictive lung diseases, other chronic lung diseases, etc.)
- Has other comorbid conditions upon admission that may affect the respiratory system (includes pneumonia or other bacterial or fungal lung infections, acute exacerbation of reactive airways disease, acute exacerbation of asthma, pulmonary edema, pleural effusion, etc.)
- Has an absolute contraindication to nebulized 3% hypertonic saline, for example, a history of an allergic or anaphylactic reaction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebulized 3% sodium chloride solutionStandardized dose of nebulized 3% sodium chloride will be provided from 4 mL vial and administered be every 6 hours. | Drug | Nebulized Hypertonic Saline + Chest Percussion Therapy |
| Chest percussion cupsAlso: MC-2247 Pediatric Manual Percussor CupThe 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. | Device | Nebulized Hypertonic Saline + Chest Percussion Therapy |
Primary outcome
Length of Hospital Stay
Time frame: Up to time of discharge (Approximately 1-5 days on average)
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 on Supplemental Oxygen Support
Time frame: Up to time of discharge (Approximately 1-5 days on average)
Measured in days from from time of admission to the general inpatient pediatrics unit until time of discharge from the general inpatient pediatrics unit.
5 secondary outcomes
Average Respiratory Rate
Time frame: Up to time of discharge (Approximately 1-5 days on average)
Average Heart Rate
Time frame: Up to time of discharge (Approximately 1-5 days on average)
Average Pulse Oximetry Reading
Time frame: Up to time of discharge (Approximately 1-5 days on average)
Number of Caregivers Who Rate Child's Response as "Improved"
Time frame: Time of discharge (Approximately 1-5 days on average)
Number of Physicians Who Rate Child's Response as "Improved"
Time frame: Time of discharge (Approximately 1-5 days on average)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuan Nguyen principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nebulized 3% sodium chloride solution and Chest percussion cups in people with Acute Bronchiolitis, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospital Stay (time frame: Up to time of discharge (Approximately 1-5 days on average)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.