Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist Versus Nasal Continuous Airway Pressure in Premature Infants

Study Overview
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Brief Summary
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The purpose of this study is to compare if a new noninvasive ventilation mode (NIV NAVA) is better in noninvasive ventilation of premature infants than currently used Nasal Continuous Airway Pressure (ncpap), and if NIV NAVA gives real benefits for patients or not. The investigators study hypothesis is that with NIV NAVA the invasive ventilation is more synchronous with patient, which will lead to a decrease in need of inspired oxygen.

Official Title
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Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist (NIV NAVA) Versus Nasal Continuous Airway Pressure (NCPAP) in Premature Infants

Conditions
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Respiratory Distress Syndrome (RDS) of Neonate

Intervention / Treatment
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* Device: NIV NAVA
* Device: Nasal continuous positive airway pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: postconceptional age 28+0 - 36+6 need of ncpap treatment and inspired oxygen for at least 60 minutes Exclusion Criteria: severe birth asphyxia, malformation or chromosomal abnormality, or other condition, which will decrease life expectancy any condition which prevents insertion of naso/orogastric tube

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 48 Hours

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: 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 ventilation with neurally adjusted ventilatory assist<br>|
| Active Comparator: ncpap<br>Patients randomized to this arm will receive noninvasive ventilation with continuous nasal CPAP as routinely in neonatal intensive care unit. | Device: Nasal continuous positive airway pressure<br>* Noninvasive respiratory support with continuous positive airway pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of inspired oxygen supply | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 30minutes- 3weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of noninvasive ventilation | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 30 minutes - 3 weeks | 
| Fraction of inspired oxygen | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 0, 1, 3 and 6hours, after which every 6 hours | 
| Blood gas analyses | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks. | 3 weeks | 
| Duration of parenteral nutrition | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NIV NAVA, non-invasive ventilation