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

Acute Bronchiolitis Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06441162
• Other study ID #: 23-01357
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 30, 2024
• Est. completion date: May 15, 2025

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: Tuan Nguyen
• Phone: 405-535-7093
• Email: tuan.nguyen[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 114
• Est. completion date: May 15, 2025
• Est. primary completion date: May 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Acute Bronchiolitis
• Bronchiolitis
• Bronchiolitis, Viral

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	Mineola	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

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