Back to resultsNeurally Adjusted Ventilatory Assist (NAVA) in Ventilatory Care of Premature Infants
Primary Purpose
Ventilation
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)
Control group, ventilation with i-Servo or Stephanie
Sponsored by
About this trial
This is an interventional treatment trial for Ventilation focused on measuring Neurally adjusted ventilatory assist NAVA, Premature infant, Edi-signal
Eligibility 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
Sites / Locations
- University hospital of Oulu
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Control
NAVA
Arm Description
Infants randomised to this arm will receive a regular nasogastric tube, and the ventilatory care is given as routinely is done.
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.
Outcomes
Primary Outcome Measures
The duration of mechanical ventilation
Secondary Outcome Measures
Complications associated to mechanical ventilation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01156467
Brief Title
Neurally Adjusted Ventilatory Assist (NAVA) in Ventilatory Care of Premature Infants
Official Title
Neurally Adjusted Ventilatory Assist (NAVA) in Ventilatory Care of Premature Infants
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilation
Keywords
Neurally adjusted ventilatory assist NAVA, Premature infant, Edi-signal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Infants randomised to this arm will receive a regular nasogastric tube, and the ventilatory care is given as routinely is done.
Arm Title
NAVA
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)
Intervention Description
Treatment with Edi-catheter
Intervention Type
Device
Intervention Name(s)
Control group, ventilation with i-Servo or Stephanie
Intervention Description
Ventilatory support is given as routinely is done in the neonatal intensive care unit, with the ventilators available. Normal nasogastric tube is used.
Primary Outcome Measure Information:
Title
The duration of mechanical ventilation
Time Frame
1 hour - 6 weeks
Secondary Outcome Measure Information:
Title
Complications associated to mechanical ventilation
Time Frame
1 hour - 6 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
9 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timo Saarela, MD, PhD
Organizational Affiliation
Oulu University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Merja Ålander, MD
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital of Oulu
City
Oulu
State/Province
Pohjois-Pohjanmaa
ZIP/Postal Code
90100
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Neurally Adjusted Ventilatory Assist (NAVA) in Ventilatory Care of Premature Infants
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