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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Oulu
Sponsor:
Information provided by (Responsible Party):
Merja Ålander, University of Oulu
ClinicalTrials.gov Identifier:
NCT01624012
First received: June 4, 2012
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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 Intervention
Respiratory Distress Syndrome (RDS) of Neonate
Device: NIV NAVA
Device: Nasal continuous positive airway pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist (NIV NAVA) Versus Nasal Continuous Airway Pressure (NCPAP) in Premature Infants

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Duration of inspired oxygen supply [ Time Frame: 30minutes- 3weeks ] [ Designated as safety issue: No ]
    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks


Secondary Outcome Measures:
  • Duration of noninvasive ventilation [ Time Frame: 30 minutes - 3 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

  • Blood gas analyses [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.

  • Duration of parenteral nutrition [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks


Estimated Enrollment: 40
Study Start Date: August 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624012

Contacts
Contact: Merja Ålander, MD +358-44-5825148 merja.alander@oulu.fi
Contact: Timo Saarela, MD, PhD +358-8-3155169 timo.saarela@ppshp.fi

Locations
Finland
Oulu University hospital Recruiting
Oulu, Finland, 90230
Contact: Merja Ålander, MD       merja.alander@oulu.fi   
Contact: Timo Saarela, MD, PhD       timo.saarela@ppshp.fi   
Principal Investigator: Merja Ålander, MD         
Principal Investigator: Mari Mahlman, MD         
Sub-Investigator: Ulla Jounio, MD         
Sub-Investigator: Eija Anttila, MD         
Sub-Investigator: Outi Peltoniemi, MD, PhD         
Principal Investigator: Timo Saarela, MD, PhD         
Principal Investigator: Mikko Hallman, Prof         
Sponsors and Collaborators
University of Oulu
  More Information

No publications provided

Responsible Party: Merja Ålander, Principal investigator, University of Oulu
ClinicalTrials.gov Identifier: NCT01624012     History of Changes
Other Study ID Numbers: EETTMK:23/2011
Study First Received: June 4, 2012
Last Updated: June 10, 2013
Health Authority: Finland: Ministry of Social Affairs and Health

Keywords provided by University of Oulu:
NIV NAVA
non-invasive ventilation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on July 20, 2014