Comparison of NIV-NAVA vs. N-CPAP After Extubation in Preterm Infants Study

Study Overview
=================
Brief Summary
-----------------
This study is a randomized controlled study to compare if a a non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is better than nasal continuous positive airway pressure (N-CPAP) after extubation in infants' < 30 weeks of gestation.

Official Title
-----------------
Comparison of Non-invasive Ventilation Neurally Adjusted Ventilatory Assist vs. Nasal Continuous Positive Airway Pressure After Extubation in Infants' < 30 Weeks of Gestation: Randomized Controlled Study

Conditions
-----------------
Endotracheal Extubation, Infant, Premature

Intervention / Treatment
-----------------
* Device: NIV-NAVA
* Device: N-CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postconceptional age less than 30+0 weeks infants who fulfill the the criteria for extubation for 6 hours extubation criteria: Ventilator rate ≤ 25 breaths/min, Peak inspiratory pressure (PIP) ≤ 16cmH2O, Fractional inspired oxygen (FiO2) ≤ 0.3 Exclusion Criteria: conditions which will decrease life expectancy major anomalies which will decrease life expectancy any anomalous conditions which involve upper and lower airway neuromuscular disease

Ages Eligible for Study
-----------------
Minimum Age: 2 Days
Maximum Age: 6 Weeks

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NIV-NAVA<br>Noninvasive ventilation in this group is practiced with NIV-NAVA | Device: NIV-NAVA<br>* Non-invasive neurally adjusted ventilatory assist<br>|
| Active Comparator: N-CPAP<br>Patients in this group will receive nasal continuous positive airway pressure as routinely in neonatal intensive care unit. | Device: N-CPAP<br>* Nasal-continuous positive airway pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extubation failure | Failure criteria pH < 7.2 with pCO2 > 70mmHg confirmed by capillary blood gas analysis in spite of maximum settings Severe apnea event requiring bag and mask resuscitation FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation Frequent desaturations (< 85%) ≥ 3/hr not responding to increased ventilatory settings or an increase in Fio2 to 1.0 | extubation - 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation | Participants will be followed for the extubation failure within 3 days after extubation | extubation - 72 hours | 
| Severe apnea event requiring bag and mask resuscitation | Participants will be followed for the extubation failure within 3 days after extubation | extubation - 72 hours | 
| FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation | Participants will be followed for the extubation failure within 7 days after extubation | extubation - 7 days | 
| pH < 7.2 with pCO2 > 70mmHg confirmed by capillary blood gas analysis in spite of maximum settings | Participants will be followed for the extubation failure within 7 days after extubation | extubation - 7 days | 
| Severe apnea event requiring bag and mask resuscitation | Participants will be followed for the extubation failure within 7 days after extubation | extubation - 7 days | 
| Bronchopulmonary dysplasia | Participants will be followed for the duration of hospital stay | postmenstrual age 36 weeks | 
| Duration of noninvasive ventilation | Participants will be followed for the duration of hospital stay | postmenstrual age 40 weeks (until discharge) | 
| Duration of inspired oxygen supply | Participants will be followed for the duration of hospital stay | postmenstrual age 40 weeks (until discharge) | 
| Duration of hospital stay | Participants will be followed for the duration of hospital stay | postmenstrual age 40 weeks (until discharge) | 
| Adverse events | Participants will be followed for 3 days after extubation | extubation - 3days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-invasive ventilation, non-invasive neurally adjusted ventilatory assist, nasal continuous positive airway pressure