Noninvasive VentilationNCT03137225
Noninvasive NAVA Versus NIPPV in Low Birthweight Premature Infants
A study testing Neurally Adjusted Ventilatory Assist and Nasal Intermittent Positive Pressure Ventilation in people with Noninvasive Ventilation and Low Birth Weight, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The investigator hypothesizes that in very low birth weight infants who require respiratory support via noninvasive ventilation, that synchronizing the ventilator breath with the baby's breath using neurally adjusted ventilatory assist (NAVA) will reduce the number and/or severity of apnea/bradycardia/desaturation… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Noninvasive Ventilation, Low Birth Weight
- What is being tested?
- Neurally Adjusted Ventilatory Assist and Nasal Intermittent Positive Pressure Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2017to 30 Jun 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- < 1501 grams (VLBW (very low birth weight) infant)
- Patient must be receiving daily caffeine therapy for apnea
- On non-invasive ventilation, either NIPPV or non-invasive NAVA
Who cannot join
- No concerns for acute sepsis (i.e., blood cultures, if drawn, have been negative for 48 hours, and no active signs/symptoms of sepsis).
- No history of meningitis or seizures
- No signs of increased intracranial pressure, including bulging fontaneIle, presence of ventricular shunt device, or ventriculomegaly by most recent ultrasound.
- Presence of Grade III or IV intraventricular hemorrhage
- No cyanotic heart defects or clinically significant congenital heart disease. Will allow PDA (patent ductus arteriosus), PFO (patent foramen ovale), and mild to moderate ASD (atrial septal defect)/VSD (ventricular septal defect) as determined by pediatric cardiology.
- Non -English speaking legal representatives (parents)
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The investigator hypothesizes that in very low birth weight infants who require respiratory support via noninvasive ventilation, that synchronizing the ventilator breath with the baby's breath using neurally adjusted ventilatory assist (NAVA) will reduce the number and/or severity of apnea/bradycardia/desaturation episodes compared to nasal intermittent positive pressure ventilation (NIPPV).
Read the detailed description
Very low birthweight (VLBW) premature infants in the NICU (Neonatal Intensive Care Unit) frequently require respiratory support for prolonged periods of time. Invasive mechanical ventilation (which requires intubating the baby with a tube to provide breaths) can lead to ventilator induced lung injury. Because of this, noninvasive respiratory support has become increasingly popular, as this form of ventilation has been shown to reduce the incidence of permanent lung injury.
There are several methods to provide non-invasive support. The gentlest is continual flow of air and oxygen via nasal cannula. However, premature infants often develop apnea, either because the signals from their immature brain are not yet sufficient or because the muscles in the back of their throat do not get enough nerve signals to maintain sufficient opening. As a result, babies on nasal cannula often develop clinical apnea/bradycardia/desaturations. Before putting these babies back on invasive ventilation, clinicians often try to provide the baby with machine breaths while still on non-invasive ventilation.
This method is called nasal intermittent positive pressure ventilation and studies have demonstrated that this method reduces the need for re-intubation in VLBW infants (1) and reduces the rate of apneic events.
A newer method of non-invasive breathing support that has been FDA approved and used in VLBW infants, synchronizes the machine generated breath with the patient's own breath. Neurally adjusted ventilatory assist (NAVA) does this by replacing the standard nasogastric tube with a nasogastric tube that has sensors which detect the baby's natural diaphragm activity, which signal the ventilator to breath in synchronization with the baby. Studies have shown that the efficacy of nasal ventilation is significantly enhanced when the machine breath is synchronized with the patient breath (2). Synchronization also reduces diaphragmatic dysfunction (3). It can improve gas delivery, reduce work of breathing, and make patients demonstrably more comfortable (4).
Neurally Adjusted Ventilatory Assist (NAVA) is a mode of partial support. NAVA can be used both in intubated patients (invasive NAVA) as well as in extubated patients who require noninvasive positive pressure ventilation (noninvasive NAVA) (5). Invasive NAVA has been shown to deliver equivalent ventilation while requiring lower peak inspiratory pressure, as well as reduced respiratory muscle load, compared to conventional pressure support ventilation.
Currently, the choice of using NIPPV or NAVA is at the clinician's discretion. Both are regularly and frequently used in the VCU (Virginia Commonwealth University) Health System's NICU. There are no studies that have examined whether NAVA triggered synchronized ventilation is more effective than nonsynchronized NIPPV. In addition, there is limited data on the synchronicity and mechanics of non-invasive NAVA in VLBW infants. Information comparing clinical and lung mechanical outcomes between NIPPV and NIV (Nasal noninvasive ventilation) NAVA would significantly benefit VLBW care providers and, consequently, their patients in getting the best evidenced based therapy.
- Conditions
- Noninvasive Ventilation, Low Birth Weight
- Being tested
- Neurally Adjusted Ventilatory Assist, Nasal Intermittent Positive Pressure Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurally Adjusted Ventilatory AssistDevice
Also called NAVA
Neurally Adjusted Ventilatory Assist delivered via RAM cannula .
Nasal Intermittent Positive Pressure VentilationDevice
Also called NIPPV
Nasal Intermittent Positive Pressure Ventilation delivered via RAM cannula
| Study group | Role | What they receive |
|---|---|---|
| Nasal Intermittent Positive Pressure Ventilation (NIPPV) Mode | Experimental | After a one hour stabilization period, during which small adjustments to the noninvasive settings can be made to clinically optimize the settings, the study will begin. A Nellcor pulse oximeter probe will be placed on an extremity to provide a continuous non-invasive downloadable measure of saturation (blood oxygen level) and heart rate. Data from the ventilator will be downloaded in real-time to a laptop.
These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to the other mode (NIPPV to NAVA), at the same PEEP (positive end-expiratory pressure) and respiratory rate. One hour will be allowed to adjust the ventilator settings. Data will then be collected for 4 hours on the second ventilation mode (NAVA) Receives: Device: Neurally Adjusted Ventilatory Assist; Device: Nasal Intermittent Positive Pressure Ventilation |
| Neurally Adjusted Ventilatory Assist (NAVA) Mode | Experimental | After a one hour stabilization period, during which small adjustments to the noninvasive settings can be made to clinically optimize the settings, the study will begin. A Nellcor pulse oximeter probe will be placed on an extremity to provide a continuous non-invasive downloadable measure of saturation (blood oxygen level) and heart rate. Data from the ventilator will be downloaded in real-time to a laptop.
These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to the other mode (NAVA to NIPPV), at the same PEEP and respiratory rate. One hour will be allowed to adjust the ventilator settings. Data will then be collected for 4 hours on the second ventilation mode (NIPPV) Receives: Device: Neurally Adjusted Ventilatory Assist; Device: Nasal Intermittent Positive Pressure Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Unexpected Events
The number of isolated apneas, bradycardias and desaturations and the number of combined events will be compared by mode of ventilation.
Measured: 8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode.
Secondary outcomes (3)
Synchronicity
Synchronicity from the ventilator at the time of an event. This will be analyzed to determine whether asynchronicity is related to increased number of events during the study.
Measured: 8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode.
Asynchronicity Counts
Overall asynchronicity counts will be determined by ventilator data that can be uploaded and analyzed with software supplied by the manufacturer.
Measured: During each four hour treatment segment
Average Pressures
Average mean airway pressure and peak inspiratory pressures required in each mode of ventilation.
Measured: 8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start15 Apr 2017
- Primary completion20 Sep 2017
- Study completion30 Jun 2019
Why it stopped: Insufficient resources available to complete the study
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Noninvasive VentilationStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Randomization - the order of modes will be assigned based on a random number table using a 5 block design to match the DSMB reporting needs.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henry J Rozycki, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137225
- Sponsor's protocol ID
- HM20005575
- Status last verified
- Nov 2019
- First submitted
- 17 Apr 2017
- Last updated
- 12 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tang S, Zhao J, Shen J, Hu Z, Shi Y. Nasal intermittent positive pressure ventilation versus nasal continuous positive airway pressure in neonates: a systematic review and meta-analysis. Indian Pediatr. 2013 Apr;50(4):371-6. doi: 10.1007/s13312-013-0122-0. Epub 2012 Oct 5.
PubMed 23255684Gizzi C, Montecchia F, Panetta V, Castellano C, Mariani C, Campelli M, Papoff P, Moretti C, Agostino R. Is synchronised NIPPV more effective than NIPPV and NCPAP in treating apnoea of prematurity (AOP)? A randomised cross-over trial. Arch Dis Child Fetal Neonatal Ed. 2015 Jan;100(1):F17-23. doi: 10.1136/archdischild-2013-305892. Epub 2014 Oct 15.
PubMed 25318667Petrof BJ, Jaber S, Matecki S. Ventilator-induced diaphragmatic dysfunction. Curr Opin Crit Care. 2010 Feb;16(1):19-25. doi: 10.1097/MCC.0b013e328334b166.
PubMed 19935062Stein H, Firestone K. Application of neurally adjusted ventilatory assist in neonates. Semin Fetal Neonatal Med. 2014 Feb;19(1):60-9. doi: 10.1016/j.siny.2013.09.005. Epub 2013 Nov 13.
PubMed 24238745Moerer O, Beck J, Brander L, Costa R, Quintel M, Slutsky AS, Brunet F, Sinderby C. Subject-ventilator synchrony during neural versus pneumatically triggered non-invasive helmet ventilation. Intensive Care Med. 2008 Sep;34(9):1615-23. doi: 10.1007/s00134-008-1163-z. Epub 2008 May 30.
PubMed 18512045
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive NAVA Versus NIPPV in Low Birthweight Premature Infants
- ClinicalTrials.gov ID
- NCT03137225
- Acronym / sponsor ID
- HM20005575
- Conditions
- Noninvasive Ventilation, Low Birth Weight
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient resources available to complete the study
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 20 Sep 2017 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Posted 12 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigator hypothesizes that in very low birth weight infants who require respiratory support via noninvasive ventilation, that synchronizing the ventilator breath with the baby's breath using neurally adjusted ventilatory assist (NAVA) will reduce the number and/or severity of apnea/bradycardia/desaturation episodes compared to nasal intermittent positive pressure ventilation (NIPPV).
Detailed description
Very low birthweight (VLBW) premature infants in the NICU (Neonatal Intensive Care Unit) frequently require respiratory support for prolonged periods of time. Invasive mechanical ventilation (which requires intubating the baby with a tube to provide breaths) can lead to ventilator induced lung injury. Because of this, noninvasive respiratory support has become increasingly popular, as this form of ventilation has been shown to reduce the incidence of permanent lung injury.
There are several methods to provide non-invasive support. The gentlest is continual flow of air and oxygen via nasal cannula. However, premature infants often develop apnea, either because the signals from their immature brain are not yet sufficient or because the muscles in the back of their throat do not get enough nerve signals to maintain sufficient opening. As a result, babies on nasal cannula often develop clinical apnea/bradycardia/desaturations. Before putting these babies back on invasive ventilation, clinicians often try to provide the baby with machine breaths while still on non-invasive ventilation.
This method is called nasal intermittent positive pressure ventilation and studies have demonstrated that this method reduces the need for re-intubation in VLBW infants (1) and reduces the rate of apneic events.
A newer method of non-invasive breathing support that has been FDA approved and used in VLBW infants, synchronizes the machine generated breath with the patient's own breath. Neurally adjusted ventilatory assist (NAVA) does this by replacing the standard nasogastric tube with a nasogastric tube that has sensors which detect the baby's natural diaphragm activity, which signal the ventilator to breath in synchronization with the baby. Studies have shown that the efficacy of nasal ventilation is significantly enhanced when the machine breath is synchronized with the patient breath (2). Synchronization also reduces diaphragmatic dysfunction (3). It can improve gas delivery, reduce work of breathing, and make patients demonstrably more comfortable (4).
Neurally Adjusted Ventilatory Assist (NAVA) is a mode of partial support. NAVA can be used both in intubated patients (invasive NAVA) as well as in extubated patients who require noninvasive positive pressure ventilation (noninvasive NAVA) (5). Invasive NAVA has been shown to deliver equivalent ventilation while requiring lower peak inspiratory pressure, as well as reduced respiratory muscle load, compared to conventional pressure support ventilation.
Currently, the choice of using NIPPV or NAVA is at the clinician's discretion. Both are regularly and frequently used in the VCU (Virginia Commonwealth University) Health System's NICU. There are no studies that have examined whether NAVA triggered synchronized ventilation is more effective than nonsynchronized NIPPV. In addition, there is limited data on the synchronicity and mechanics of non-invasive NAVA in VLBW infants. Information comparing clinical and lung mechanical outcomes between NIPPV and NIV (Nasal noninvasive ventilation) NAVA would significantly benefit VLBW care providers and, consequently, their patients in getting the best evidenced based therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization - the order of modes will be assigned based on a random number table using a 5 block design to match the DSMB reporting needs.
| Arm | Type | Receives |
|---|---|---|
| Nasal Intermittent Positive Pressure Ventilation (NIPPV) Mode | Experimental | Device: Neurally Adjusted Ventilatory Assist, Device: Nasal Intermittent Positive Pressure VentilationAfter a one hour stabilization period, during which small adjustments to the noninvasive settings can be made to clinically optimize the settings, the study will begin. A Nellcor pulse oximeter probe will be placed on an extremity to provide a continuous non-invasive downloadable measure of saturation (blood oxygen level) and heart rate. Data from the ventilator will be downloaded in real-time to a laptop. These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to the other mode (NIPPV to NAVA), at the same PEEP (positive end-expiratory pressure) and respiratory rate. One hour will be allowed to adjust the ventilator settings. Data will then be collected for 4 hours on the second ventilation mode (NAVA) |
| Neurally Adjusted Ventilatory Assist (NAVA) Mode | Experimental | Device: Neurally Adjusted Ventilatory Assist, Device: Nasal Intermittent Positive Pressure VentilationAfter a one hour stabilization period, during which small adjustments to the noninvasive settings can be made to clinically optimize the settings, the study will begin. A Nellcor pulse oximeter probe will be placed on an extremity to provide a continuous non-invasive downloadable measure of saturation (blood oxygen level) and heart rate. Data from the ventilator will be downloaded in real-time to a laptop. These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to the other mode (NAVA to NIPPV), at the same PEEP and respiratory rate. One hour will be allowed to adjust the ventilator settings. Data will then be collected for 4 hours on the second ventilation mode (NIPPV) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- < 1501 grams (VLBW (very low birth weight) infant)
- Patient must be receiving daily caffeine therapy for apnea
- On non-invasive ventilation, either NIPPV or non-invasive NAVA
Key exclusion criteria (6 listed)
- No concerns for acute sepsis (i.e., blood cultures, if drawn, have been negative for 48 hours, and no active signs/symptoms of sepsis).
- No history of meningitis or seizures
- No signs of increased intracranial pressure, including bulging fontaneIle, presence of ventricular shunt device, or ventriculomegaly by most recent ultrasound.
- Presence of Grade III or IV intraventricular hemorrhage
- No cyanotic heart defects or clinically significant congenital heart disease. Will allow PDA (patent ductus arteriosus), PFO (patent foramen ovale), and mild to moderate ASD (atrial septal defect)/VSD (ventricular septal defect) as determined by pediatric cardiology.
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 |
|---|---|---|
| Neurally Adjusted Ventilatory AssistAlso: NAVANeurally Adjusted Ventilatory Assist delivered via RAM cannula . | Device | Nasal Intermittent Positive Pressure Ventilation (NIPPV) Mode, Neurally Adjusted Ventilatory Assist (NAVA) Mode |
| Nasal Intermittent Positive Pressure VentilationAlso: NIPPVNasal Intermittent Positive Pressure Ventilation delivered via RAM cannula | Device | Nasal Intermittent Positive Pressure Ventilation (NIPPV) Mode, Neurally Adjusted Ventilatory Assist (NAVA) Mode |
Primary outcome
Number of Unexpected Events
Time frame: 8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode.
The number of isolated apneas, bradycardias and desaturations and the number of combined events will be compared by mode of ventilation.
3 secondary outcomes
Synchronicity
Time frame: 8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode.
Asynchronicity Counts
Time frame: During each four hour treatment segment
Average Pressures
Time frame: 8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23255684Tang S, Zhao J, Shen J, Hu Z, Shi Y. Nasal intermittent positive pressure ventilation versus nasal continuous positive airway pressure in neonates: a systematic review and meta-analysis. Indian Pediatr. 2013 Apr;50(4):371-6. doi: 10.1007/s13312-013-0122-0. Epub 2012 Oct 5.
- Results publication: PubMed 25318667Gizzi C, Montecchia F, Panetta V, Castellano C, Mariani C, Campelli M, Papoff P, Moretti C, Agostino R. Is synchronised NIPPV more effective than NIPPV and NCPAP in treating apnoea of prematurity (AOP)? A randomised cross-over trial. Arch Dis Child Fetal Neonatal Ed. 2015 Jan;100(1):F17-23. doi: 10.1136/archdischild-2013-305892. Epub 2014 Oct 15.
- Results publication: PubMed 19935062Petrof BJ, Jaber S, Matecki S. Ventilator-induced diaphragmatic dysfunction. Curr Opin Crit Care. 2010 Feb;16(1):19-25. doi: 10.1097/MCC.0b013e328334b166.
- Results publication: PubMed 24238745Stein H, Firestone K. Application of neurally adjusted ventilatory assist in neonates. Semin Fetal Neonatal Med. 2014 Feb;19(1):60-9. doi: 10.1016/j.siny.2013.09.005. Epub 2013 Nov 13.
- Results publication: PubMed 18512045Moerer O, Beck J, Brander L, Costa R, Quintel M, Slutsky AS, Brunet F, Sinderby C. Subject-ventilator synchrony during neural versus pneumatically triggered non-invasive helmet ventilation. Intensive Care Med. 2008 Sep;34(9):1615-23. doi: 10.1007/s00134-008-1163-z. Epub 2008 May 30.
- 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.
Henry J Rozycki, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurally Adjusted Ventilatory Assist and Nasal Intermittent Positive Pressure Ventilation in people with Noninvasive Ventilation and Low Birth Weight, run by Virginia Commonwealth University at 1 site 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 3 inclusion and 6 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 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 12 Nov 2019). 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?
Number of Unexpected Events (time frame: 8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03137225, which also lists 5 linked publications.
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 12 Nov 2019.