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

NCT06441162 | Terminated Phase 4 Results FDA Drug FDA Device

• 1 other identifier: 23-01357
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

acute bronchiolitis; nebulized hypertonic saline; chest percussion therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Average Respiratory Rate

  Up to time of discharge (Approximately 1-5 days on average)

• Average Heart Rate

  Up to time of discharge (Approximately 1-5 days on average)

• Average Pulse Oximetry Reading

  Up to time of discharge (Approximately 1-5 days on average)

• Number of Caregivers Who Rate Child's Response as "Improved"

  Time of discharge (Approximately 1-5 days on average)

• Number of Physicians Who Rate Child's Response as "Improved"

  Time of discharge (Approximately 1-5 days on average)

Study Arms (2)

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.

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.

Interventions

Nebulized 3% sodium chloride solution DRUG

Standardized dose of nebulized 3% sodium chloride will be provided from 4 mL vial and administered be every 6 hours.

Nebulized Hypertonic Saline + Chest Percussion Therapy

Chest percussion cups DEVICE

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

Nebulized Hypertonic Saline + Chest Percussion Therapy

Eligibility Criteria

• Age: 0 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

Mineola, New York, 11501, United States

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Tuan Nguyen
• Organization: NYU Langone Health

tuan.nguyen@nyulangone.org

405-535-7093

Study Officials

• Tuan Nguyen

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: July 15, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: February 20, 2026
• Results First Posted: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (1)