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Procedure

Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation Arm 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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hour average, values collected at ~4 hour intervals.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average Baseline Electrical Activity of the Diaphragm (Edi)

Average Respiratory Severity Score (RSS)

Baseline Electrical Activity of the Diaphragm (Edi)

+1 more

Secondary outcome measures

Duration of Non-Invasive Ventilation

Frequency of increasing ventilatory support

Number of participants requiring intubation

+1 more

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor

444 Previous Clinical Trials

582,440 Total Patients Enrolled

1 Trials studying Bronchiolitis

227 Patients Enrolled for Bronchiolitis

Jacqueline Weingarten, MDPrincipal InvestigatorPhysician

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals who are being enrolled in this medical study?

"Indeed, as per the details available on clinicaltrials.gov, this study is currently seeking eligible patients. The trial was initially posted on December 18th, 2023 and recently updated on the same date. In total, they aim to enroll 120 participants at a single research site."

Answered by AI

Are eligible patients able to enroll in this ongoing trial at the present time?

"Indeed, as reported on clinicaltrials.gov, this trial is currently actively recruiting participants. The initial posting of the trial was made on December 18th, 2023 and it was last updated on the same date."

Answered by AI

Is the eligibility criteria for this medical study inclusive of individuals below the age of 50?

"To be eligible for enrollment in this clinical trial, participants must be between the ages of zero and two."

Answered by AI

Can individuals such as myself participate in this clinical study?

"In order to be eligible for this medical study, individuals must have a diagnosis of bronchiolitis and fall within the age range of 0 to 2 years. The trial has capacity for a total enrollment of 120 participants."

Answered by AI

What is the primary goal or purpose of this medical study?

"The primary focus of this research is to assess the Baseline Respiratory Severity Score (RSS) over an average duration of approximately 48 hours. The RSS values will be recorded at intervals around every 4 hours. Additional outcomes being evaluated include the Duration of Non-Invasive Ventilation, which measures how long patients require non-invasive ventilation in hours. Furthermore, the study aims to determine the number of participants who need intubation due to bronchiolitis and track any instances where physicians increase ventilatory support settings on the ventilator (excluding FiO2), while remaining within protocol parameters; these events will be counted during the study period"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Non-Invasive Ventilation Versus Neurally-Adjusted Ventilatory Assistance (NAVA) for the Treatment of Bronchiolitis

2023. "Non-Invasive Ventilation Versus Neurally-Adjusted Ventilatory Assistance (NAVA) for the Treatment of Bronchiolitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06053684.

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