Back to resultsNon-invasive Ventilation With Neurally Adjusted Ventilatory Assist Versus Nasal Continuous Airway Pressure in Premature Infants (NIV NAVA)
Primary Purpose
Respiratory Distress Syndrome (RDS) of Neonate
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
NIV NAVA
Nasal continuous positive airway pressure
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome (RDS) of Neonate focused on measuring NIV NAVA, non-invasive ventilation
Eligibility Criteria
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
Sites / Locations
- Oulu University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
NIV NAVA
ncpap
Arm Description
Noninvasive ventilation in this group is practiced with NIV NAVA
Patients randomized to this arm will receive noninvasive ventilation with continuous nasal CPAP as routinely in neonatal intensive care unit.
Outcomes
Primary Outcome Measures
Duration of inspired oxygen supply
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary Outcome Measures
Duration of noninvasive ventilation
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Fraction of inspired oxygen
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Blood gas analyses
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
Duration of parenteral nutrition
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01624012
Brief Title
Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist Versus Nasal Continuous Airway Pressure in Premature Infants
Acronym
NIV NAVA
Official Title
Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist (NIV NAVA) Versus Nasal Continuous Airway Pressure (NCPAP) in Premature Infants
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome (RDS) of Neonate
Keywords
NIV NAVA, non-invasive ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NIV NAVA
Arm Type
Active Comparator
Arm Description
Noninvasive ventilation in this group is practiced with NIV NAVA
Arm Title
ncpap
Arm Type
Active Comparator
Arm Description
Patients randomized to this arm will receive noninvasive ventilation with continuous nasal CPAP as routinely in neonatal intensive care unit.
Intervention Type
Device
Intervention Name(s)
NIV NAVA
Intervention Description
Non invasive ventilation with neurally adjusted ventilatory assist
Intervention Type
Device
Intervention Name(s)
Nasal continuous positive airway pressure
Intervention Description
Noninvasive respiratory support with continuous positive airway pressure
Primary Outcome Measure Information:
Title
Duration of inspired oxygen supply
Description
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Time Frame
30minutes- 3weeks
Secondary Outcome Measure Information:
Title
Duration of noninvasive ventilation
Description
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Time Frame
30 minutes - 3 weeks
Title
Fraction of inspired oxygen
Description
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Time Frame
0, 1, 3 and 6hours, after which every 6 hours
Title
Blood gas analyses
Description
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
Time Frame
3 weeks
Title
Duration of parenteral nutrition
Description
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Oulu University hospital
City
Oulu
ZIP/Postal Code
90230
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist Versus Nasal Continuous Airway Pressure in Premature Infants
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