Randomized Crossover of NAVA and Synchronized Intermittent Pressure Ventilation in Neonates and Infants

Study Overview
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Brief Summary
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This study is a single center, prospective cohort crossover study comparing mechanically ventilated neonates and infants on Neurally Adjusted Ventilatory Assist (NAVA) and synchronized intermittent mandatory ventilation with pressure control plus pressure support (SIMV(PC) + PS) modes. This design will allow for direct comparison of two commonly used ventilator modalities in the neonatal intensive care unit (NICU) to determine if one mode is superior to the other with regards to respiratory mechanics and estimated energy expenditure. It is hypothesized that neonates and infants will have improved respiratory severity score (MAP X FiO2) utilizing NAVA compared to the SIMV (PC) + PS mode but will have increased estimated energy expenditure.

Detailed Description
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This single center, prospective cohort crossover study will involve mechanically ventilated neonates and infants who are determined to be on stable ventilator settings in either the NAVA or SIMV(PC) + PS modes. This design will allow for direct comparison of two commonly used ventilator modalities in the neonatal intensive care unit (NICU) to determine if one mode is superior to the other with regards to respiratory mechanics and energy expenditure. Infants will be screened for stability criteria including: being stable on the ventilator in either SIMV (PC) + PS or NAVA mode, on weaning or unchanged ventilatory support in previous 12 hours, and no need of escalation of ventilatory pressure or rate in prior 12 hours. After screening criteria is met and consent has been obtained, data will be retrospectively collected for 12 hours prior to randomization. After the subject is randomized, the infant will be stabilized and data will be collected for 12 hours in the randomized mode. Data will then be collected for 12 hours afterwards in the crossover mode. Data will be collected in areas of patient demographics, diagnoses, indications for mechanical ventilation, hemodynamic variables and respiratory parameters. While in each mode, the patient will also have indirect calorimetry obtained to determine estimated energy expenditure of each mode.

Official Title
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Respiratory Severity and Caloric Consumption on NAVA: Randomized Crossover Trial of NAVA and SIMV

Conditions
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Respiratory Insufficiency, Infant, Newborn, Disease

Intervention / Treatment
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* Device: Neurally Adjusted Ventilatory Assist
* Device: Synchronized Interm. Mandatory Assist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neonates and infants, 22 weeks gestation age or older at birth Require mechanical ventilation for respiratory support in either SIMV (PC) + PS or NAVA modes Stable on the ventilator with a fractional inspired oxygen requirement (FiO2) of 0.60 or less. Stable on the ventilator with weaning or unchanged ventilatory support without need of escalation of ventilatory pressure or rate in prior 12 hours. Exclusion Criteria: Major congenital anomalies Neurologic compromise of respiratory drive Phrenic nerve palsy Sedated enough to suppress respiratory drive Respiratory support with volume mechanical ventilation Respiratory support with high frequency oscillatory ventilation

Ages Eligible for Study
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Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Neurally Adjusted Ventilatory Assist<br>Subject will be randomized to NAVA ventilation. Intervention is mechanical ventilation with Neurally Adjusted Ventilatory Assist for 12 hours. | Device: Neurally Adjusted Ventilatory Assist<br>* The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist<br>Device: Synchronized Interm. Mandatory Assist<br>* The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support<br>|
| Other: Synchronized Interm. Mandatory Assist<br>Subject will be randomized to SIMV(PC)PS ventilation. Intervention is mechanical ventilation with Synchronized Intermittent Mandatory Assist with Pressure Support for 12 hours. | Device: Neurally Adjusted Ventilatory Assist<br>* The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist<br>Device: Synchronized Interm. Mandatory Assist<br>* The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Severity Score (MAP X FiO2) | The respiratory severity score will be calculated throughout 24 hour time frame prior to and after study initiation to determine the subject's respiratory severity prior to the randomization, after randomization and after crossover. The respiratory severity score (RSS) is a simplified severity score consisting of the mean airway pressure (MAP) multiplied by the fraction of inspired oxygen (FiO2). This score ranges from 0 to 12, with a higher score indicating more severe disease. | 12 hours and 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy Expenditure | The subject will have indirect calorimetry performed twice during the study on each mode, 12 hours after randomization and 12 hours after crossover to determine the approximate amount of energy expenditure needed for each mode of mechanical ventilation. Energy expenditure is calculated by using the Harris-Benedict equation, resulted in kcal/kg per day. | 12 hours and 24 hours |