NCT06053684 Non-Invasive Ventilation Versus Neurally-Adjusted Ventilatory Assistance (NAVA) for the Treatment of Bronchiolitis
| NCT ID | NCT06053684 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montefiore Medical Center |
| Condition | Bronchiolitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2023-12-18 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2023-12-18 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 reduced escalations in therapy (including intubation) when compared to using a standard mode of non-invasive ventilation. Neurally-Adjusted Ventilatory Assistance (NAVA) has been shown to result in greater synchrony then the standard mode of non-invasive ventilation. The study team hypothesizes that this improved synchrony can result in important clinical improvements when NAVA is used to treat children with bronchiolitis.
Eligibility 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
Contact & Investigator
Jacqueline Weingarten, MD
PRINCIPAL INVESTIGATOR
Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT06053684 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 2 Years, studying Bronchiolitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06053684 currently recruiting?
Yes, NCT06053684 is actively recruiting participants. Contact the research team at jweingar@montefiore.edu for enrollment information.
Where is the NCT06053684 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT06053684 clinical trial?
NCT06053684 is sponsored by Montefiore Medical Center. The principal investigator is Jacqueline Weingarten, MD at Montefiore Medical Center. The trial plans to enroll 130 participants.