Status:
RECRUITING
Non-Invasive Ventilation Versus Neurally-Adjusted Ventilatory Assistance (NAVA) for the Treatment of Bronchiolitis
Lead Sponsor:
Montefiore Medical Center
Conditions:
Bronchiolitis
Eligibility:
All Genders
Up to 2 years
Phase:
NA
Brief Summary
This project aims to answer whether the use of a Neurally-Adjusted Ventilatory Assistance mode for non-invasive ventilation in pediatric patients with bronchiolitis results in improved comfort and red...
Detailed Description
Bronchiolitis is a common diagnosis in pediatric hospitals and critical care units. Viral infection in younger patients often results in increased work of breathing, hypoxemia, impaired ventilation, a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06053684
Start Date
December 18 2023
End Date
March 1 2027
Last Update
September 5 2025
Active Locations (1)
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1
Children's Hospital at Montefiore
The Bronx, New York, United States, 10467