Acute Bronchiolitis
Conditions
Keywords
acute bronchiolitis, nebulized hypertonic saline, chest percussion therapy
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.
Interventions
DRUGNebulized 3% sodium chloride solution
Standardized dose of nebulized 3% sodium chloride will be provided from 4 mL vial and administered be every 6 hours.
DEVICEChest 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.
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Months to 24 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Respiratory Rate | Up to time of discharge (Approximately 1-5 days on average) | Assessed every 4 hours and as needed in addition. |
| Average Heart Rate | Up to time of discharge (Approximately 1-5 days on average) | Assessed every 4 hours and as needed in addition. |
| 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 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." |
| 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." |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTuan Nguyen
NYU Langone Health
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 9 months |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 38 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 75 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 70 |
| other Total, other adverse events | 0 / 5 | 0 / 70 |
| serious Total, serious adverse events | 0 / 5 | 0 / 70 |
Outcome results
None listed