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DSME recommendation due to recommendations on study redesign.
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| Name | Class |
|---|---|
| Rhode Island Hospital | OTHER |
| Children's Miracle Network | OTHER |
| American Respiratory Care Foundation | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAVA | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | up to 5 days per study arm |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 5 days per study arm |
| Stress |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erik Jensen, MD, MSCE | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States | ||
| Rhode Island Hospital (Hasboro Children's Hospital) |
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12 subjects were enrolled in the study and 9 completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Neurally Adjusted Ventilatory Assist (NAVA) Followed by CMV | Subjects will be ventilated on neurally adjusted ventilatory assist (NAVA) mode with data collected for the first 5 day time, followed by a second day time frame in which subjects will be ventilated with conventional mechanical ventilation (CMV). Data will be collected throughout the two 5 day periods for comaprison. NAVA: 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. CMV: 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 |
| FG001 | Conventional Flow Triggered Mechanical Ventilation (CMV) Followed by NAVA | Subjects will be ventilated with Conventional Mechanical Ventilation (CMV) with for the first 5 day time frame, followed by a second 5 day time frame in which subjects will be ventilated with Neurally Adjusted Ventilatory Assist (NAVA) mode. Data will be collected throughout both 5 day time frames for comparison. CMV: 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 NAVA: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mechanical Ventilation Sequence 1 |
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| Mechanical Ventilation Sequence 2 |
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12 patients were enrolled. 9 completed the study. This is a crossover study design; therefore, each subject completed both arms of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All study participants include Conventional Flow Triggered Mechanical Ventilation (CMV) and Neurally Adjusted Ventilatory Assist (NAVA) CMV: 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 NAVA: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | 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). | Three were withdrawn early during the NAVA arm. 2 due to concern for increased hypoxemic episodes and 1 was removed for ventilator technical fault unrelated to patient safety. There is partial data for the 3 subjects who were withdrawn early from the NAVA arm. 1 was never able to be successfully placed on NAVA mode for disordered breathing. | Posted | Mean | Standard Deviation | Oxygen Saturation Index (OSI) | up to 5 days per study arm |
Up to 11 days
Due to the medical complexity of subjects, only intervention related AEs were captured.
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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 | Conventional Flow Triggered Mechanical Ventilation (CMV) | Subjects will be ventilated with conventional mechanical ventilation with data collected for the 5 day time frame to compare to the experimental arm CMV: 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased risk for Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | concern for increased hypoxemic episodes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natalie Napolitano, PhD, RRT-NPS, FAARC | The Children's Hospital of Philadelphia | 215-590-1708 | NapolitanoN@chop.edu |
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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 | Aug 31, 2022 | Oct 14, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 4, 2024 | Oct 14, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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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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Prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation
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|
| CMV | Device | 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 |
|
|
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. |
| up to 5 days per study arm |
| Providence |
| Rhode Island |
| 02903 |
| United States |
| NOT COMPLETED |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Gestational Age at Birth | Number | Count of Participants |
|
| Birth Weight | Number | Count of Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Conventional Mechanical Ventilation (CMV) | Subjects will be ventilated with Conventional Mechanical Ventilation (CMV) with data collected for the first 5 day time frame, followed by a second 5 day time frame to compare to the experimental arm. CMV: 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 |
| OG001 | Neurally Adjusted Ventilatory Assist (NAVA) | Subjects will be ventilated on neurally adjusted ventilatory assist (NAVA) mode with data collected for the first 5 day time frame, followed by a second 5 day time frame to compare to the experimental arm. NAVA: 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. |
|
|
| Secondary | 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. | Three were withdrawn early during the NAVA arm. 2 due to concern for increased hypoxemic episodes and 1 was removed for ventilator technical fault unrelated to patient safety. There is partial data for the 3 subjects who were withdrawn early from the NAVA arm. 1 was never able to be successfully placed on NAVA mode for disordered breathing. | Posted | Mean | Standard Deviation | mg/kg/day | up to 5 days per study arm |
|
|
|
| Secondary | 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. | Three were withdrawn early during the NAVA arm. 2 due to concern for increased hypoxemic episodes and 1 was removed for ventilator technical fault unrelated to patient safety. There is partial data for the 3 subjects who were withdrawn early from the NAVA arm. 1 was never able to be successfully placed on NAVA mode for disordered breathing. | Posted | Median | Inter-Quartile Range | μg/dL | up to 5 days per study arm |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 2 |
| 12 |
| EG001 | Neurally Adjusted Ventilatory Assist (NAVA) | 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 NAVA: 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. | 0 | 12 | 0 | 12 | 4 | 12 |
|
| Procedural Event | Injury, poisoning and procedural complications | Non-systematic Assessment | Vaso-vagal response with insertion of NAVA catheter |
|
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| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |