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Mechanical Ventilation
NAVA vs. CMV for Severe Bronchopulmonary Dysplasia
N/A
Recruiting
Led By Erik Jensen, MD, MSCE
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Receiving invasive mechanical ventilation for ongoing lung disease
Severe BPD [as per National Institutes of Health (NIH) consensus definition] diagnosed at 36 weeks postmenstrual age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 days per study arm
Awards & highlights
Study Summary
This trial will compare two modes of mechanical ventilation - conventional and neurally adjusted ventilatory assist - for 20 infants with severe bronchopulmonary dysplasia.
Who is the study for?
This trial is for prematurely born infants and young children up to 2 years old with severe bronchopulmonary dysplasia (BPD). They must be on invasive mechanical ventilation, not expected to be extubated within 11 days of joining, and have parental consent. Infants with certain health conditions or recent treatments are excluded.Check my eligibility
What is being tested?
The study compares two types of breathing support in severely ill babies: conventional mechanical ventilation (CMV) and neurally adjusted ventilatory assist (NAVA). It will look at lung function, oxygen exchange, and comfort levels during treatment in a small group of patients.See study design
What are the potential side effects?
While the trial description does not specify side effects, both NAVA and CMV can potentially cause discomfort due to the artificial airway used for breathing support. There may also be risks associated with changes in respiratory settings.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on a ventilator due to lung disease.
Select...
My baby was diagnosed with severe BPD at 36 weeks postmenstrual age.
Select...
I am between 36 weeks postmenstrual age and 2 years old.
Select...
My pregnancy is 32 weeks along or less.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 days per study arm
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 days per study arm
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Oxygen saturation (SpO2) index
Secondary outcome measures
Sedation Medications
Stress
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Neurally Adjusted Ventilatory Assist (NAVA)Experimental Treatment1 Intervention
Subjects will be ventilated on neurally adjusted ventilatory assist (NAVA) mode with data collected for the 5 day time frame to compare with placebo arm
Group II: Conventional Flow Triggered Mechanical Ventilation (CMV)Placebo Group1 Intervention
Subjects will be ventilated with conventional mechanical ventilation with data collected for the 5 day time frame to compare to the experimental arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NAVA
2013
N/A
~220
Find a Location
Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,581,034 Total Patients Enrolled
7 Trials studying Bronchopulmonary Dysplasia
424 Patients Enrolled for Bronchopulmonary Dysplasia
American Respiratory Care FoundationUNKNOWN
Children's Miracle NetworkOTHER
22 Previous Clinical Trials
1,814 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have more than 10% air leaking around the breathing tube.I am on a ventilator due to lung disease.I haven't needed significant changes to my breathing support settings in the last 24 hours.You have a "do not resuscitate" (DNR) status or if further treatment is unlikely to help.I am currently on a high-frequency ventilator.You are not expected to be able to breathe without a ventilator within 11 days after joining the study.I have not had muscle relaxant drugs in the last 72 hours.My baby was diagnosed with severe BPD at 36 weeks postmenstrual age.I have a known issue with my diaphragm.You have serious birth defects.I am between 36 weeks postmenstrual age and 2 years old.My pregnancy is 32 weeks along or less.
Research Study Groups:
This trial has the following groups:- Group 1: Neurally Adjusted Ventilatory Assist (NAVA)
- Group 2: Conventional Flow Triggered Mechanical Ventilation (CMV)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum capacity of participants for this clinical experiment?
"Indeed, the clinicaltrials.gov page for this research confirms that enrollment is ongoing. This trial was published on September 13th 2021 and its information was most recently revised on September 26th 2022. 25 participants are needed at 2 sites in order to complete the study's recruitment goals."
Answered by AI
Are new participants still able to join this experiment?
"According to clinicaltrials.gov, the recruitment phase of this medical study is still ongoing. The trial was initially posted on September 13th 2021 and last updated on September 26th 2022."
Answered by AI
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