Comparing two types of non-invasive ventilation for treating bronchiolitis in young children
Comparison of Conventional Non-Invasive Ventilation and Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Ventilation for the Treatment of Bronchiolitis
This study is testing if a new type of breathing support called NAVA can make young children with bronchiolitis more comfortable and reduce the need for more serious treatments like intubation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 0 Years to 2 Years |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT06053684 on ClinicalTrials.gov |
What this trial studies
This project aims to determine if Neurally-Adjusted Ventilatory Assistance (NAVA) provides better comfort and reduces the need for more intensive therapy, such as intubation, compared to standard non-invasive ventilation in pediatric patients with bronchiolitis. The study hypothesizes that NAVA's improved synchrony with the patient's breathing can lead to better clinical outcomes. Bronchiolitis, a common respiratory condition in infants, often requires hospitalization and can lead to severe respiratory failure. The study will involve children under two years old diagnosed with bronchiolitis who are admitted to the pediatric ICU.
Who should consider this trial
Good fit: Ideal candidates are children under the age of two with a diagnosis of bronchiolitis requiring hospitalization.
Not a fit: Patients with chronic lung disease, cyanotic heart lesions, or those requiring imminent intubation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved respiratory support for infants with bronchiolitis, reducing the need for invasive procedures.
How similar studies have performed: While the use of NAVA is gaining interest, this specific comparison with standard non-invasive ventilation in bronchiolitis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients under the age of two years old with a diagnosis of bronchiolitis presenting to the pediatric ICU * Patient's provider believes there is equipoise between the use of NAVA or conventional non-invasive ventilation for the patient Exclusion Criteria: * Patients unable to utilize a nasogastric tube * Patients with a diagnosis of chronic lung disease, cyanotic heart lesions, or congestive heart failure * Patients with hypotonia * Patients likely to require imminent intubation: \>0.60 Fraction of Inspired Oxygen (FiO2); Carbon Dioxide (CO2) \> 60, frequent apneas, clinician determines patient unlikely to tolerate non-invasive modality) * Patients with hemodynamic instability, defined as the need for vasoactive medication
Where this trial is running
The Bronx, New York
- Children's Hospital at Montefiore — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jacqueline Weingarten, MD — Montefiore Medical Center
- Study coordinator: Jacqueline Weingarten, MD
- Email: jweingar@montefiore.edu
- Phone: 2017459825
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.