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Clinical Trials/NCT01624012
NCT01624012
Completed
Not Applicable

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

University of Oulu1 site in 1 country40 target enrollmentAugust 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Distress Syndrome (RDS) of Neonate
Sponsor
University of Oulu
Enrollment
40
Locations
1
Primary Endpoint
Duration of inspired oxygen supply
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
May 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Merja Ålander

Principal investigator

University of Oulu

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Duration of parenteral nutrition(3 weeks)
  • Blood gas analyses(3 weeks)
  • Duration of noninvasive ventilation(30 minutes - 3 weeks)
  • Fraction of inspired oxygen(0, 1, 3 and 6hours, after which every 6 hours)

Study Sites (1)

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