Clinical trial NCT06441162: Efficacy Of Combined Nebulized Hypertonic Saline and Chest Percussion Therapy in Acute Viral Bronchiolitis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Bronchiolitis
Keywords: acute bronchiolitis
nebulized hypertonic saline
chest percussion therapy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 75
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

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

Primary outcomes:
measure: Length of Hospital Stay
timeFrame: Up to time of discharge (Approximately 1-5 days on average)
measure: Time on Supplemental Oxygen Support
timeFrame: Up to time of discharge (Approximately 1-5 days on average)
Secondary outcomes:
measure: Average Respiratory Rate
timeFrame: Up to time of discharge (Approximately 1-5 days on average)
measure: Average Heart Rate
timeFrame: Up to time of discharge (Approximately 1-5 days on average)
measure: Average Pulse Oximetry Reading
timeFrame: Up to time of discharge (Approximately 1-5 days on average)
measure: Number of Caregivers who Rate Child's Response as "Improved"
timeFrame: Time of discharge (Approximately 1-5 days on average)
measure: Number of Physicians who Rate Child's Response as "Improved"
timeFrame: Time of discharge (Approximately 1-5 days on average)
Other outcomes:
Locations:
city: Mineola
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Tuan Nguyen
role: PRINCIPAL_INVESTIGATOR
References: