Bronchopulmonary DysplasiaNCT04821453
NAVA vs. CMV Crossover in Severe BPD
A study testing NAVA and CMV in people with Bronchopulmonary Dysplasia and Neurally Adjusted Ventilatory Assist, run by Children's Hospital of Philadelphia at 2 sites in United States.
Trial summary
This prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation will compare measures of pulmonary mechanics, respiratory gas exchange, and patient comfort between conventional flow triggered mechanical ventilation and neurally adjusted ventilatory assist (NAVA) among 20 prematurely… Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Bronchopulmonary Dysplasia, Neurally Adjusted Ventilatory Assist, Mechanical Ventilation
- What is being tested?
- NAVA and CMV
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Sep 2021to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational ages (GA) ≤ 32 weeks
- Current age between 36 weeks postmenstrual age (PMA) and 2 years corrected age
- Severe BPD [as per National Institutes of Health (NIH) consensus definition] diagnosed at 36 weeks postmenstrual age
- Receiving invasive mechanical ventilation for ongoing lung disease
- Not expected to be ready for extubation within 11 days following enrollment
- Parental consent
Who cannot join
- Severe congenital anomalies
- Known diaphragmatic defect
- Current treatment with high frequency mechanical ventilation
- Do not resuscitate (DNR) Status or Futility of Care
- >10% leak around the artificial airway,
- Treatment with neuromuscular blockade within 72 hours prior to enrollment
- Acute respiratory instability defined as a ventilator rate increase > 15 beats per minute (bpm), Positive end-expiratory pressure (PEEP) increase > 2 cm/water (H2O), sustained FiO2 increase > 20%, and/or prescribed increase in tidal volume > 2 mL/kg within 24 hours prior to enrollment will be excluded.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Rhode Island Hospital (Hasboro Children's Hospital)
Providence, Rhode Island, 02903
About this study
Official title: Pilot Cross-Over Trial of Neurally Adjusted Ventilatory Assist (NAVA) and Conventional Flow Triggered Mechanical Ventilation (CMV) in Severe Bronchopulmonary Dysplasia (sBPD)
This prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation will compare measures of pulmonary mechanics, respiratory gas exchange, and patient comfort between conventional flow triggered mechanical ventilation and neurally adjusted ventilatory assist (NAVA) among 20 prematurely born infants and young children receiving invasive respiratory support for severe bronchopulmonary dysplasia (BPD).
Read the detailed description
Most research to date in neonatal lung disease has focused on bronchopulmonary dysplasia (BPD) prevention. As a result, insufficient investigation has been performed to define optimal respiratory management strategies for infants and young children with established BPD. Thus, there is no robust evidence base to guide ventilator management to promote lung disease recovery and support neurodevelopment in this population. Neurally adjusted ventilatory assist (NAVA) is an alternative to conventional flow triggered ventilation that has shown promise for improving respiratory gas exchange, patient-ventilator interaction, and work of breathing in preterm neonates. The safety and efficacy of NAVA in infants and young children with established, severe BPD is uncertain. This prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation will compare measures of pulmonary mechanics, respiratory gas exchange, and patient comfort between conventional flow triggered mechanical ventilation and NAVA among 20 prematurely born infants and young children receiving invasive respiratory support for severe BPD.
- Being tested
- NAVA, CMV
- Keywords
- BPD, Bronchopulmonary Dysplasia
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVADevice
Also called Neurally Adjusted Ventilatory Assist
NAVA mode of mechanical ventilation provide the trigger for a spontaneous breath from the diaphragmatic movement instead of diaphragm and allows the patient to control the dynamics of the breath generally set in CMV mode.
CMVDevice
Also called Conventional Flow Triggered Mechanical Ventilation
CMV mode of mechanical ventilation that provides a trigger for a spontaneous breath from the airway flow sensor with dynamics of the breath set as required by the mode
| Study group | Role | What they receive |
|---|---|---|
| Conventional Flow Triggered Mechanical Ventilation (CMV) | Placebo comparator | Subjects will be ventilated with conventional mechanical ventilation with data collected for the 5 day time frame to compare to the experimental arm Receives: Device: CMV |
| Neurally Adjusted Ventilatory Assist (NAVA) | Experimental | 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 Receives: Device: NAVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Saturation (SpO2) Index
The Oxygenation Saturation Index (OSI) is a composite measure of the severity of hypoxic respiratory failure. It quantifies how much ventilatory support is required to achieve a given level of oxygen saturation. Lower OSI values indicate better oxygenation and better clinical status. Higher OSI values indicate worse oxygenation and more severe respiratory failure. Oxygen saturation index will be measured by assessing if invasive mechanical ventilation with NAVA compared to CMV improves respiratory gas exchange in patients receiving invasive respiratory support for BPD. This will be calculated as the mean, time-weighted daily oxygen saturation (SpO2) index ([mean airway pressure x Fraction of inspired oxygen (FiO2)]/SpO2).
Measured: up to 5 days per study arm
Secondary outcomes (2)
Sedation Medications
The need for sedation medication will be assessed by comparing the needs for sedation by the average daily dose milligram/kilogram (mg/kg) of sedation medications on invasive mechanical ventilation with NAVA compared to CMV.
Measured: up to 5 days per study arm
Stress
Patient stress will be assessed by collecting salivary swabs three times per day to measure cortisol levels. The daily cortisol levels will be averaged during each arm of the study. The averaged cortisol level per arm will be assessed and compared as a marker for patient stress on invasive mechanical ventilation with NAVA compared to CMV. Elevated salivary cortisol reflects greater stress response, whereas lower levels reflect reduced physiologic stress.
Measured: up to 5 days per study arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start13 Sep 2021
- Primary completion8 Nov 2024
- Study completion28 Feb 2025
Why it stopped: DSME recommendation due to recommendations on study redesign.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Rhode Island Hospital, Children's Miracle Network, American Respiratory Care Foundation
- Responsible party
- Sponsor
- Investigators
- Erik Jensen, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821453
- Sponsor's protocol ID
- 19-017175
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2021
- Last updated
- 20 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Cross-Over Trial of Neurally Adjusted Ventilatory Assist (NAVA) and Conventional Flow Triggered Mechanical Ventilation (CMV) in Severe Bronchopulmonary Dysplasia (sBPD)
- ClinicalTrials.gov ID
- NCT04821453
- Acronym / sponsor ID
- 19-017175
- Keywords
- BPD, Bronchopulmonary Dysplasia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSME recommendation due to recommendations on study redesign.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Rhode Island Hospital, Children's Miracle Network, American Respiratory Care Foundation
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Posted 6 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation will compare measures of pulmonary mechanics, respiratory gas exchange, and patient comfort between conventional flow triggered mechanical ventilation and neurally adjusted ventilatory assist (NAVA) among 20 prematurely born infants and young children receiving invasive respiratory support for severe bronchopulmonary dysplasia (BPD).
Detailed description
Most research to date in neonatal lung disease has focused on bronchopulmonary dysplasia (BPD) prevention. As a result, insufficient investigation has been performed to define optimal respiratory management strategies for infants and young children with established BPD. Thus, there is no robust evidence base to guide ventilator management to promote lung disease recovery and support neurodevelopment in this population. Neurally adjusted ventilatory assist (NAVA) is an alternative to conventional flow triggered ventilation that has shown promise for improving respiratory gas exchange, patient-ventilator interaction, and work of breathing in preterm neonates. The safety and efficacy of NAVA in infants and young children with established, severe BPD is uncertain. This prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation will compare measures of pulmonary mechanics, respiratory gas exchange, and patient comfort between conventional flow triggered mechanical ventilation and NAVA among 20 prematurely born infants and young children receiving invasive respiratory support for severe BPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation
| Arm | Type | Receives |
|---|---|---|
| Conventional Flow Triggered Mechanical Ventilation (CMV) | Placebo comparator | Device: CMVSubjects will be ventilated with conventional mechanical ventilation with data collected for the 5 day time frame to compare to the experimental arm |
| Neurally Adjusted Ventilatory Assist (NAVA) | Experimental | Device: NAVASubjects will be ventilated on neurally adjusted ventilatory assist (NAVA) mode with data collected for the 5 day time frame to compare with placebo arm |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Gestational ages (GA) ≤ 32 weeks
- Current age between 36 weeks postmenstrual age (PMA) and 2 years corrected age
- Severe BPD [as per National Institutes of Health (NIH) consensus definition] diagnosed at 36 weeks postmenstrual age
- Receiving invasive mechanical ventilation for ongoing lung disease
- Not expected to be ready for extubation within 11 days following enrollment
Key exclusion criteria (7 listed)
- Severe congenital anomalies
- Known diaphragmatic defect
- Current treatment with high frequency mechanical ventilation
- Do not resuscitate (DNR) Status or Futility of Care
- >10% leak around the artificial airway,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAVAAlso: Neurally Adjusted Ventilatory AssistNAVA mode of mechanical ventilation provide the trigger for a spontaneous breath from the diaphragmatic movement instead of diaphragm and allows the patient to control the dynamics of the breath generally set in CMV mode. | Device | Neurally Adjusted Ventilatory Assist (NAVA) |
| CMVAlso: Conventional Flow Triggered Mechanical VentilationCMV mode of mechanical ventilation that provides a trigger for a spontaneous breath from the airway flow sensor with dynamics of the breath set as required by the mode | Device | Conventional Flow Triggered Mechanical Ventilation (CMV) |
Primary outcome
Oxygen Saturation (SpO2) Index
Time frame: up to 5 days per study arm
The Oxygenation Saturation Index (OSI) is a composite measure of the severity of hypoxic respiratory failure. It quantifies how much ventilatory support is required to achieve a given level of oxygen saturation. Lower OSI values indicate better oxygenation and better clinical status. Higher OSI values indicate worse oxygenation and more severe respiratory failure. Oxygen saturation index will be measured by assessing if invasive mechanical ventilation with NAVA compared to CMV improves respiratory gas exchange in patients receiving invasive respiratory support for BPD. This will be calculated as the mean, time-weighted daily oxygen saturation (SpO2) index ([mean airway pressure x Fraction of inspired oxygen (FiO2)]/SpO2).
2 secondary outcomes
Sedation Medications
Time frame: up to 5 days per study arm
Stress
Time frame: up to 5 days per study arm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Jensen, MD, MSCE principal investigator
Children's Hospital of Philadelphia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAVA and CMV in people with Bronchopulmonary Dysplasia and Neurally Adjusted Ventilatory Assist, run by Children's Hospital of Philadelphia at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Saturation (SpO2) Index (time frame: up to 5 days per study arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.