Efficacy Of Combined Nebulized Hypertonic Saline and Chest Percussion Therapy in Acute Viral Bronchiolitis
- Conditions
- Acute Bronchiolitis
- Interventions
- Drug: Nebulized 3% sodium chloride solutionDevice: Chest percussion cups
- Registration Number
- NCT06441162
- Lead Sponsor
- NYU Langone Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 114
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
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nebulized Hypertonic Saline + Chest Percussion Therapy Nebulized 3% sodium chloride solution 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. Nebulized Hypertonic Saline + Chest Percussion Therapy Chest percussion cups 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.
- Primary Outcome Measures
Name Time Method Time on Supplemental Oxygen Support Up to time of discharge (Approximately 1-5 days on average) Measured in days from from time of admission to the general inpatient pediatrics unit until time of discharge from the general inpatient pediatrics unit.
Length of Hospital Stay Up to time of discharge (Approximately 1-5 days on average) Measured in days from from time of admission to the general inpatient pediatrics unit until time of discharge from the general inpatient pediatrics unit.
- Secondary Outcome Measures
Name Time Method Number of Caregivers who Rate Child's Response as "Improved" Time of discharge (Approximately 1-5 days on average) Caregivers will be given a survey in which they will rate their child's overall response following the treatments as "Improved," "Unchanged," or "Worsened."
Average Pulse Oximetry Reading Up to time of discharge (Approximately 1-5 days on average) Assessed every 4 hours and as needed in addition.
Number of Physicians who Rate Child's Response as "Improved" Time of discharge (Approximately 1-5 days on average) Caregivers will be given a survey in which they will rate their child's overall response following the treatments as "Improved," "Unchanged," or "Worsened."
Average Heart Rate Up to time of discharge (Approximately 1-5 days on average) Assessed every 4 hours and as needed in addition.
Average Respiratory Rate Up to time of discharge (Approximately 1-5 days on average) Assessed every 4 hours and as needed in addition.
Trial Locations
- Locations (1)
NYU Langone Health
🇺🇸Mineola, New York, United States