Combining nebulized saline and chest therapy for treating acute bronchiolitis in young children
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.
PHASE4 · NYU Langone Health · NCT06441162
This study tests if using a mix of salty mist and gentle chest tapping can help young children with bronchiolitis breathe better while they're in the hospital.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 0 Months to 24 Months |
| Sex | All |
| Sponsor | NYU Langone Health (other) |
| Locations | 1 site (Mineola, New York) |
| Trial ID | NCT06441162 on ClinicalTrials.gov |
What this trial studies
This study examines the effectiveness of using nebulized hypertonic saline in conjunction with chest percussion therapy for infants and toddlers aged 0 to 24 months who are hospitalized with acute bronchiolitis. Participants will receive treatments of 3% nebulized saline along with 3 minutes of chest percussion every 6 hours. The study aims to determine if this combined approach improves respiratory outcomes compared to standard care. Data for the control group will be collected retrospectively from similar patients.
Who should consider this trial
Good fit: Ideal candidates are infants and toddlers aged 0 to 24 months who are hospitalized with acute bronchiolitis and require supplemental oxygen.
Not a fit: Patients admitted to the pediatric intensive care unit or those with pre-existing respiratory conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved recovery times and respiratory function in young children suffering from acute bronchiolitis.
How similar studies have performed: While this approach is not widely tested, similar studies have shown promise in using nebulized treatments for respiratory conditions in young children.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Mineola, New York
- NYU Langone Health — Mineola, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Tuan Nguyen — NYU Langone Health
- Study coordinator: Tuan Nguyen
- Email: tuan.nguyen@nyulangone.org
- Phone: 405-535-7093
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Bronchiolitis, acute bronchiolitis, nebulized hypertonic saline, chest percussion therapy