Efficacy Of Combined Nebulized Hypertonic Saline and Chest Percussion Therapy in Acute Viral Bronchiolitis

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.

Study Overview

• Status: Terminated
• Conditions: Acute Bronchiolitis
• Intervention / Treatment: Drug: Nebulized 3% sodium chloride solution; Device: Chest percussion cups

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Mineola, New York, United States, 11501
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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:

• Age 0 to 24 months
• Admitted to the general inpatient pediatrics unit
• Has a diagnosis of acute bronchiolitis
• Receiving supplemental oxygen support

Exclusion Criteria:

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)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Device: 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.; Other Names: MC-2247 Pediatric Manual Percussor Cup
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to time of discharge (Approximately 1-5 days on average)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Respiratory Rate	Assessed every 4 hours and as needed in addition.	Up to time of discharge (Approximately 1-5 days on average)
Average Heart Rate	Assessed every 4 hours and as needed in addition.	Up to time of discharge (Approximately 1-5 days on average)
Average Pulse Oximetry Reading	Assessed every 4 hours and as needed in addition.	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 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 of discharge (Approximately 1-5 days on average)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Tuan Nguyen, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Actual): May 15, 2025
• Study Completion (Actual): May 15, 2025

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: acute bronchiolitis; nebulized hypertonic saline; chest percussion therapy
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis; Bronchiolitis, Viral; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: 23-01357

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to tuan.nguyen@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No