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

NCT ID: NCT06441162

Last Updated: 2026-02-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2025-05-15

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nebulized 3% sodium chloride solution

Intervention Type: DRUG

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

Chest percussion cups

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Other Intervention Names

MC-2247 Pediatric Manual Percussor Cup

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tuan Nguyen

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

Mineola, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

23-01357

Identifier Type: -

Identifier Source: org_study_id