Ventilator Weaning Outcome Between NIV-NAVA and Nasal CPAP (or IMV ) Modes in Premature Neonates

Study Overview
=================
Brief Summary
-----------------
Premature neonates are prone to respiratory distress and need ventilator support because of the rapid breathing and large variations in respiratory patterns. The setting and adjustment of the ventilator for premature neonate is not easy, often resulting in poor patient-ventilator interaction, increased work of breathing, patient discomfort and delayed weaning . Recently, a new ventilation mode (NAVA; Neurally Adjusted Ventilatory Assist) mode, allows the respirator to provide a proportional ventilation mode based on the patients' diaphragm electrical activity, which was validated in many domestic and international clinical researches. The NAVA mode improves patient-ventilator interaction, reduces work of breathing and contributes to early weaning and extubation . When participating in this study, the neonate with receive a special oral tube placement, which is used to replace the original gastric tube to monitor the electrical activity of the diaphragm.

Detailed Description
-----------------
Premature neonates are prone to respiratory distress and need ventilator support because of the rapid breathing and large variations in respiratory patterns. The setting and adjustment of the ventilator for premature neonate is not easy, often resulting in poor patient-ventilator interaction, increased work of breathing, patient discomfort and delayed weaning . Recently, a new ventilation mode (NAVA; Neurally Adjusted Ventilatory Assist) mode, allows the respirator to provide a proportional ventilation mode based on the patients' diaphragm electrical activity, which was validated in many domestic and international clinical researches. The NAVA mode improves patient-ventilator interaction, reduces work of breathing and contributes to early weaning and extubation . When participating in this study, the neonate with receive a special oral tube placement, which is used to replace the original gastric tube to monitor the electrical activity of the diaphragm. The aims of the study are: 1. To select the appropriate ventilation mode and parameters (for example, switch to NIV-NAVA mode); 2. To monitor intermittent apnea, bradycardia and the frequency of cyanosis, 3. To pay attention to the changes in maximum peak pressure, adjust appropriate pressure support, and avoid lung injury. The predicted outcomes of NAVA mode for premature neonate may include : 1. Measurement of the lower PIP value to maintain proper and synchronized ventilation; 2. Monitoring of the diaphragm activity (Edi) signal to evaluate the work of breathing and estimate the weaning time.

Official Title
-----------------
Ventilator Weaning Outcome Between Non-invasive Neural Adjusted Ventilator Assist and Nasal Continuous Positive Airway Pressure (or Intermittent Mandatory Ventilation) Modes in Premature Neonates

Conditions
-----------------
Respiratory Distress Syndrome in Premature Infant

Intervention / Treatment
-----------------
* Procedure: NIV-NAVA
* Procedure: Nasal CPAP or NIMV mode


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature >30week Respiratory distress Exclusion Criteria: Premature < 30weeks ENT contraindication: fistula Contraindication with orogastric tube or nasogastric

Ages Eligible for Study
-----------------
Minimum Age: 30 Weeks
Maximum Age: 37 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIN-NAVA<br>Premature>30weeks with respiratory distress PI to determine eligibility or exclusion Randomize to either NIV-NAVA or Nasal CPAP (NIMV) 1:1 randomization PI will not be blinded to the intervention (not feasible) Place the catheter to optimize position ABG or VBG to be obtained at 2 hrs. post NIV-NAVA NIV-NAVA settings will be weaned or increased as the clinical situation demands and outlined in the protocol | Procedure: NIV-NAVA<br>* NAVA mode during Non-invasive ventilation<br>|
| Active Comparator: Nasal CPAP or NIMV<br>Premature>30weeks with respiratory distress PI to determine eligibility or exclusion Randomize to either NIV-NAVA or Nasal CPAP (NIMV) 1:1 randomization PI will not be blinded to the intervention (not feasible) Place the catheter to optimize position ABG or VBG to be obtained at 2 hrs. post Nasal CPAP or NIMV NCPAP or NIMV settings will be weaned or increased as the clinical situation demands and outlined in the protocol | Procedure: Nasal CPAP or NIMV mode<br>* Nasal CPAP or NIMV mode during Non-invasive ventilation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of mechanical ventilation | Defined as the time from the start of mechanical ventilation, defined as either the time of in the ICU and until successful weaning mechanical ventilator, with successful weaning defined as ≥5 days of unassisted spontaneous breathing after . | Until the date of discharge from ICU, up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily patient physiological blood gas status | Defined as daily PaO2/FiO2 from randomization until successful Weaning. | Until the date of discharge from ICU, up to 4 weeks | 
| Length of ICU stay | Defined as the duration of ICU admission from randomization to ICU discharge | Until the date of discharge from ICU, up to 4 weeks | 
| Length of hospital stay | Defined as the duration of hospital admission from randomization to hospital discharge | Until the date of discharge from ICU, up to 4 weeks | 
| Difference in the number of patient ventilator asynchrony | To assess the difference of number of patient ventilator asynchrony | Entire period of ventilatory support, an average of 7 days | 
| Ventilation parameters: peak inspiratory pressure in NIV-NAVA | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min ) | Entire period of ventilatory support, an average of 7 days | 
| Ventilation parameters : tidal volume in NIV-NAVA | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min ) | through study completion, an average of 7 days | 
| Ventilation parameters : PEEP in NIV-NAVA | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min ) | through study completion, an average of 7 days | 
| Ventilation parameters : FiO2 in NIV-NAVA | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min ) | through study completion, an average of 7 days | 
| Ventilation parameters : Edi peak in NIV-NAVA | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min ) | through study completion, an average of 7 days | 
| Ventilation parameters : Edi min in NIV-NAVA | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min ) | through study completion, an average of 7 days | 
| Ventilation parameters : peak inspiratory pressure in NCPA (or NIMV) | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC Level, RR) | through study completion, an average of 7 days | 
| Ventilation parameters : tidal volume in NCPA(or NIMV) | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC, RR) | through study completion, an average of 7 days | 
| Ventilation parameters : PEEP in NCPA (or NIMV) | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PCl, RR) | through study completion, an average of 7 days | 
| Ventilation parameters : FiO2 in NCPA or NIMV | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC, RR) | through study completion, an average of 7 days | 
| Ventilation parameters : pressure control level in NIMV | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC, RR) | through study completion, an average of 7 days | 
| Ventilation parameters : RR in NIMV | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC, RR) | through study completion, an average of 7 days | 
| Clinical parameters of Premature: heart rate in NIV-NAVA | Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period | through study completion, an average of 7days | 
| Clinical parameters of Premature: respiratory rate in NIV-NAVA | Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period | through study completion, an average of 7days | 
| Clinical parameters of Premature: SpO2 in NIV-NAVA | Evolution of clinical parameters (SpO2) at the beginning and end of each period | through study completion, an average of 7days | 
| Clinical parameters of Premature: blood pressure in NIV-NAVA | Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period | through study completion, an average of 7days | 
| Clinical parameters of Premature: heart rate in NCPA(or NIMV) | Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period | through study completion, an average of 7days | 
| Clinical parameters of Premature: respiratory rate in NCPA (or NIMV) | Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period | through study completion, an average of 7days | 
| Clinical parameters of Premature: blood pressure in NCPA (or NIMV) | Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period | through study completion, an average of 7days | 
| Clinical parameters of Premature: SpO2 in NCPAP(or NIMV) | Evolution of clinical parameters (SpO2) at the beginning and end of each period | through study completion, an average of 7days |