Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients
1 other identifier
interventional
170
1 country
1
Brief Summary
The purpose of this study is to find out if NAVA-technology is better in detecting patients own inspiratory efforts during mechanical ventilation than currently used flow-triggering in PRVC (pressure regulated volume controlled) ventilation, and if NAVA gives real benefits for patients or not. The investigators study hypothesis is that NAVA-technology can detect spontaneous inspiration more accurately than currently used methods, and thus will lead to more smooth adaptation to mechanical ventilation in pediatric patients. The investigators expect this to decrease the time of ventilatory support needed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 19, 2010
CompletedFirst Posted
Study publicly available on registry
January 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMay 25, 2012
May 1, 2012
2.7 years
January 19, 2010
May 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary outcome is the duration of mechanical ventilation
30minutes-3weeks
Secondary Outcomes (1)
Amount of sedative medication needed
30minutes-3weeks
Study Arms (2)
NAVA
ACTIVE COMPARATORChildren randomised in this arm will be treated with neurally adjusted ventilatory assist
Control
ACTIVE COMPARATORPatients randomized to control group will be treated with pressure controlled ventilation (PC) when they are newborns and older children in this group will be treated with pressure regulated volume controlled (PRVC) ventilation.
Interventions
Treatment with neurally adjusted ventilatory assist
Treatment with PC or PRVC ventilation.
Eligibility Criteria
You may qualify if:
- All children from term newborn (37+0 gestational week) to 16-year-old needing ventilatory care at least 30 minutes
You may not qualify if:
- Any condition that prevents feeding tube positioning. Critical ventilatory or perfusion problems.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Oulu
Oulu, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 19, 2010
First Posted
January 26, 2010
Study Start
September 1, 2009
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
May 25, 2012
Record last verified: 2012-05