Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist Versus Nasal Continuous Airway Pressure in Premature Infants (NIV NAVA)
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|ClinicalTrials.gov Identifier: NCT01624012|
Recruitment Status : Completed
First Posted : June 20, 2012
Last Update Posted : May 12, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome (RDS) of Neonate||Device: NIV NAVA Device: Nasal continuous positive airway pressure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist (NIV NAVA) Versus Nasal Continuous Airway Pressure (NCPAP) in Premature Infants|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||May 2016|
Active Comparator: NIV NAVA
Noninvasive ventilation in this group is practiced with NIV NAVA
Device: NIV NAVA
Non invasive ventilation with neurally adjusted ventilatory assist
Active Comparator: ncpap
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
Noninvasive respiratory support with continuous positive airway pressure
- Duration of inspired oxygen supply [ Time Frame: 30minutes- 3weeks ]Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
- Duration of noninvasive ventilation [ Time Frame: 30 minutes - 3 weeks ]Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
- Fraction of inspired oxygen [ Time Frame: 0, 1, 3 and 6hours, after which every 6 hours ]Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
- Blood gas analyses [ Time Frame: 3 weeks ]Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
- Duration of parenteral nutrition [ Time Frame: 3 weeks ]Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624012
|Oulu University hospital|
|Oulu, Finland, 90230|