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Procedure

NAVA vs Standard Ventilation for Bronchiolitis

N/A
Recruiting
Led By Jacqueline Weingarten, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Patients under the age of two years old with a diagnosis of bronchiolitis presenting to the pediatric ICU
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hour average, values collected at ~4 hour intervals.
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to find out if using a special mode of non-invasive ventilation called Neurally-Adjusted Ventilatory Assistance (NAVA) can improve comfort and reduce the need for more intensive treatment

Who is the study for?
This trial is for children under two years old diagnosed with bronchiolitis who are in the pediatric ICU. Specific details about who can't join were not provided.
What is being tested?
The study compares two types of non-invasive breathing support: standard ventilation and Neurally-Adjusted Ventilatory Assistance (NAVA). It aims to see if NAVA offers better comfort and reduces the need for more intense treatments like intubation.
What are the potential side effects?
Potential side effects are not detailed, but may include discomfort or issues related to wearing a ventilation mask, skin irritation from the equipment, or respiratory complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hour average, values collected at ~4 hour intervals.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hour average, values collected at ~4 hour intervals. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average Baseline Electrical Activity of the Diaphragm (Edi)
Average Respiratory Severity Score (RSS)
Baseline Electrical Activity of the Diaphragm (Edi)
+1 more
Secondary study objectives
Duration of Non-Invasive Ventilation
Frequency of increasing ventilatory support
Number of participants requiring intubation
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation ArmExperimental Treatment1 Intervention
This arm with utilize a NAVA mode of non-invasive ventilation within protocol parameters.
Group II: Standard Non-Invasive Mechanical Servo Ventilation ArmActive Control1 Intervention
This arm will utilize a standard mode of non-invasive ventilation within protocol parameters.

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
457 Previous Clinical Trials
588,501 Total Patients Enrolled
Jacqueline Weingarten, MDPrincipal InvestigatorPhysician
~47 spots leftby Jul 2025
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