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

May 10, 2016 updated by: Merja Ålander, University of Oulu

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland, 90230
        • Oulu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30minutes- 3weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 minutes - 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
0, 1, 3 and 6hours, after which every 6 hours
Blood gas analyses
Time Frame: 3 weeks
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
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
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

June 4, 2012

First Submitted That Met QC Criteria

June 17, 2012

First Posted (Estimate)

June 20, 2012

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EETTMK:23/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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