Neurally Adjusted Ventilatory Assist (NAVA) in Ventilatory Care of Premature Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merja Ålander, University of Oulu
ClinicalTrials.gov Identifier:
NCT01156467
First received: July 1, 2010
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to find out, whether it is possible to improve the ventilatory care of premature infants by using Neurally adjusted ventilatory assist (NAVA).

The study hypothesis is that by using NAVA-technology and/or by monitoring Edi-signal (the electrical signal of diaphragm), it is possible to accomplish ventilatory care to premature infants more individually.


Condition Intervention
Ventilation
Device: Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)
Device: Control group, ventilation with i-Servo or Stephanie

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neurally Adjusted Ventilatory Assist (NAVA) in Ventilatory Care of Premature Infants

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • The duration of mechanical ventilation [ Time Frame: 1 hour - 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications associated to mechanical ventilation [ Time Frame: 1 hour - 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Infants randomised to this arm will receive a regular nasogastric tube, and the ventilatory care is given as routinely is done.
Device: Control group, ventilation with i-Servo or Stephanie
Ventilatory support is given as routinely is done in the neonatal intensive care unit, with the ventilators available. Normal nasogastric tube is used.
Active Comparator: NAVA
Infants randomised to this arm will receive and Edi-catheter as an oro-/nasogastric tube and the Edi-signal will be monitored and when possible NAVA-ventilation used.
Device: Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)
Treatment with Edi-catheter

Detailed Description:

Asynchrony means that the timing of support given by the ventilator is different from patients own breathing pattern. Asynchrony during ventilatory care may increase the risk for complications especially in premature infants with immature lungs.

In this study investigators will compare currently used ventilation methods to a new neurally adjusted ventilatory assist (NAVA). The aim is to find out, whether by using this new method it is possible to decrease the complications associated to ventilatory care and to shorten the need for mechanical ventilation.

  Eligibility

Ages Eligible for Study:   up to 9 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All children of postconceptional age from 28+0 to 36+6 weeks needing mechanical ventilation for at least 60 minutes

Exclusion Criteria:

  • severe birth asphyxia, malformations, chromosomal abnormality or other condition, which will decrease the length of life
  • condition which prevents the positioning of an oro-/nasogastric tube
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156467

Locations
Finland
University hospital of Oulu
Oulu, Pohjois-Pohjanmaa, Finland, 90100
Sponsors and Collaborators
University of Oulu
Investigators
Study Director: Timo Saarela, MD, PhD Oulu University Hospital
Principal Investigator: Merja Ålander, MD Oulu University Hospital
  More Information

No publications provided

Responsible Party: Merja Ålander, MD, University of Oulu
ClinicalTrials.gov Identifier: NCT01156467     History of Changes
Other Study ID Numbers: EETTMK:26/2010
Study First Received: July 1, 2010
Last Updated: June 10, 2013
Health Authority: Finland: Finnish Medicines Agency
Finland: Social and health ministry
European Union: Parliament of the European Union

Keywords provided by University of Oulu:
Neurally adjusted ventilatory assist NAVA
Premature infant
Edi-signal

ClinicalTrials.gov processed this record on April 17, 2014