Neurally Adjusted Ventilatory Assist (NAVA) in Ventilatory Care of Premature Infants
NCT ID: NCT01156467
Last Updated: 2013-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2010-04-30
2013-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Infants randomised to this arm will receive a regular nasogastric tube, and the ventilatory care is given as routinely is done.
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.
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.
Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)
Treatment with Edi-catheter
Interventions
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Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)
Treatment with Edi-catheter
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* condition which prevents the positioning of an oro-/nasogastric tube
9 Weeks
ALL
No
Sponsors
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University of Oulu
OTHER
Responsible Party
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Merja Ålander
MD
Principal Investigators
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Timo Saarela, MD, PhD
Role: STUDY_DIRECTOR
Oulu University Hospital
Merja Ålander, MD
Role: PRINCIPAL_INVESTIGATOR
Oulu University Hospital
Locations
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University hospital of Oulu
Oulu, North Ostrobothnia, Finland
Countries
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Other Identifiers
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EETTMK:26/2010
Identifier Type: -
Identifier Source: org_study_id
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