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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurally Adjusted Ventilatory Assist | Device | Neurally Adjusted Ventilatory Assist delivered via RAM cannula . |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode. |
| Asynchronicity Counts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry J Rozycki, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23255684 | Result | 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. | |
| 25318667 | Result | Gizzi 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. |
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Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
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| ID | Title | Description |
|---|---|---|
| FG000 | NIPPV Then NAVA Mode | 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. The ventilator will be set Nasal Intermittent Positive Pressure Ventilation (NIPPV) mode. These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to Neurally Adjusted Ventilatory Assist (NAVA) mode, 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) |
| FG001 | NAVA Then NIPPV Mode | 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. The ventilator will be set to Neurally Adjusted Ventilatory Assist (NAVA) mode. These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to Nasal Intermittent Positive Pressure Ventilation (NIPPV) mode , 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First 4 Hour Measurement Period |
| |||||||||||||
| Second 4 Hour Measurement Period |
|
Only 1 subject enrolled
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| ID | Title | Description |
|---|---|---|
| BG000 | NIPPV Then NAVA Mode | 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. The ventilator will be set Nasal Intermittent Positive Pressure Ventilation (NIPPV) mode. These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to Neurally Adjusted Ventilatory Assist (NAVA) mode, 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant. | Posted | 8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode. |
|
8 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NIPPV Then NAVA Mode | 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. The ventilator will be set Nasal Intermittent Positive Pressure Ventilation (NIPPV) mode. These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to Neurally Adjusted Ventilatory Assist (NAVA) mode, 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) |
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Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Henry J. Rozycki, MD | Virginia Commonwealth University | 8048289602 | henry.rozycki@vcuhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 8, 2016 | Nov 6, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059725 | Interactive Ventilatory Support |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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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.
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| Nasal Intermittent Positive Pressure Ventilation | Device | Nasal Intermittent Positive Pressure Ventilation delivered via RAM cannula |
|
|
Overall asynchronicity counts will be determined by ventilator data that can be uploaded and analyzed with software supplied by the manufacturer. |
| During each four hour treatment segment |
| Average Pressures | Average mean airway pressure and peak inspiratory pressures required in each mode of ventilation. | 8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode. |
| 19935062 | Result | Petrof BJ, Jaber S, Matecki S. Ventilator-induced diaphragmatic dysfunction. Curr Opin Crit Care. 2010 Feb;16(1):19-25. doi: 10.1097/MCC.0b013e328334b166. |
| 24238745 | Result | Stein 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. |
| 18512045 | Result | Moerer 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. |
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| BG001 | NAVA Then NIPPV Mode | 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. The ventilator will be set to Neurally Adjusted Ventilatory Assist (NAVA) mode. These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to Nasal Intermittent Positive Pressure Ventilation (NIPPV) mode , 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. |
| BG002 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Sex: Female, Male | Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant. | Number | participants |
|
| OG001 | NAVA Then NIPPV Mode | 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. The ventilator will be set to Neurally Adjusted Ventilatory Assist (NAVA) mode. These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to Nasal Intermittent Positive Pressure Ventilation (NIPPV) mode , 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. |
|
| Secondary | 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. | Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant. | Posted | 8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode. |
|
|
| Secondary | Asynchronicity Counts | Overall asynchronicity counts will be determined by ventilator data that can be uploaded and analyzed with software supplied by the manufacturer. | Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant. | Posted | During each four hour treatment segment |
|
|
| Secondary | Average Pressures | Average mean airway pressure and peak inspiratory pressures required in each mode of ventilation. | Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant. | Posted | 8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode. |
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| EG001 | NAVA Then NIPPV Mode | 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. The ventilator will be set to Neurally Adjusted Ventilatory Assist (NAVA) mode. These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to Nasal Intermittent Positive Pressure Ventilation (NIPPV) mode , 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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